Documentation secuTrial Export Formats

Documentation

secuTrial® Export Formats

Valid for Version 5.1

As of 09.05.2017

© interActive Systems, Berlin 2017

Documentation secuTrial® 5.1 Export Formats

Table of Contents

1. Introduction.................................................................................................................................................. 5

New features in secuTrial® 5.0.3...................................................................................................5

1.1 Export Options .................................................................................................................................... 6

Description...................................................................................................................................... 7

Project and Centre ......................................................................................................................... 8

Visit................................................................................................................................................. 8

Patients........................................................................................................................................... 8

Format............................................................................................................................................. 8

Included data.................................................................................................................................. 9

Data handling................................................................................................................................ 11

Filter data records.........................................................................................................................11

Send email.................................................................................................................................... 12

1.2 Export after Search............................................................................................................................ 12

2. Export Model.............................................................................................................................................. 13

2.1 Standard (non-rectangular) structure.................................................................................................13

2.2 Rectangular structure........................................................................................................................14

3. SAS-Format............................................................................................................................................... 16

3.1 Introduction........................................................................................................................................ 16

3.2 Data types......................................................................................................................................... 16

Date Formats................................................................................................................................ 16

Other Data Types.......................................................................................................................... 17

Labels........................................................................................................................................... 18

Code Lists..................................................................................................................................... 18

Images.......................................................................................................................................... 18

Numbers....................................................................................................................................... 18

3.3 SAS Format Problems....................................................................................................................... 19

4. SPSS Format............................................................................................................................................. 20

4.1 Introduction........................................................................................................................................ 20

4.2 Data types......................................................................................................................................... 20

Date formats................................................................................................................................. 20

Code Lists..................................................................................................................................... 21

Images.......................................................................................................................................... 21

Numbers....................................................................................................................................... 22

5. CSV & Text Formats.................................................................................................................................. 23

5.1 Introduction........................................................................................................................................ 23

5.2 Data types......................................................................................................................................... 23

Date Formats................................................................................................................................ 23

Code Lists..................................................................................................................................... 24

Images.......................................................................................................................................... 25

Numbers....................................................................................................................................... 25

6. Table descriptions...................................................................................................................................... 26

6.1 Explanations for variable description flags.........................................................................................26

6.2 visitplan /vp (Project visit plan)..........................................................................................................27

6.3 visitplanforms / vpfs (Forms shown in visits)......................................................................................28

6.4 forms / fs (Forms).............................................................................................................................. 28

6.5 questions / qs (Questions)................................................................................................................. 29

6.6 items / is (Items)................................................................................................................................ 30

6.7 deactivatedcodes / dc (Deactivated Codelists Options).....................................................................31

6.8 centres / ctr (Centres)........................................................................................................................ 31

As of 09.05.2017 - 2 - © by interActive Systems


6.9 casenodes / cn (Patient information).................................................................................................32

6.10 atcasenodes / atcn (Patient information history)................................................................................33

6.11 atcasevisitplans / atcvp (Patient visit plan history).............................................................................34

6.12 atadverseevents / atae (Patient's adverse event and follow-up history)............................................36

6.13 queries / qac (Queries)......................................................................................................................38

6.14 comments / cts (Comments)..............................................................................................................40

6.15 sdv / sdv (Source Data Verification)...................................................................................................42

6.16 atsdv / atsdv (Source Data Verification audit trail).............................................................................44

6.17 miv / miv (Missing Values)................................................................................................................46

6.18 atmiv / atmiv (Missing Values audit trail)............................................................................................47

6.19 mnp…: eCRF Data............................................................................................................................ 49

6.20 atmnp…: Audit Trail eCRF................................................................................................................. 54

6.21 emnp…: Sub-Documents.................................................................................................................. 55

6.22 atemnp…: Audit Trail Sub-Documents..............................................................................................56

6.23 images / img (Images).......................................................................................................................57

6.24 data ................................................................................................................................................... 59

6.25 formnumbers..................................................................................................................................... 66

7. CDISC ODM 1.3........................................................................................................................................ 67

7.1 Introduction........................................................................................................................................ 67

7.2 ODM Data structure........................................................................................................................... 67

Omitted information.......................................................................................................................67

Artifical study elements................................................................................................................. 68

Audit Trail...................................................................................................................................... 68

Queries and Comments................................................................................................................68

Hidden data................................................................................................................................... 69

secuTrial® and CDISC.................................................................................................................. 69

Date Formats................................................................................................................................ 70

7.3 secuTrial® Vendor Schema Extension..............................................................................................72

7.4 Structure summary............................................................................................................................ 74

7.5 Element description: General information..........................................................................................76

<ODM> ........................................................................................................................................ 76

7.6 Element description: Project setup....................................................................................................77

<Study> ........................................................................................................................................ 77

<StudyName> .............................................................................................................................. 77

<StudyDescription> ......................................................................................................................77

<ProtocolName> ......................................................................................................................... 77

<MetaDataVersion>......................................................................................................................77

<Protocol>..................................................................................................................................... 78

<StudyEventRef>..........................................................................................................................78

<StudyEventDef>..........................................................................................................................78

<FormRef>.................................................................................................................................... 79

<FormDef>.................................................................................................................................... 79

<Description>................................................................................................................................ 80

<ItemGroupRef>........................................................................................................................... 80

<ItemGroupDef>........................................................................................................................... 80

<ItemRef>..................................................................................................................................... 81

<Alias>.......................................................................................................................................... 82

<ItemDef>..................................................................................................................................... 82

<CodeListRef>.............................................................................................................................. 83

<CodeList>.................................................................................................................................... 83



<CodeListItem>............................................................................................................................. 83

<TranslatedText>..........................................................................................................................83

7.7 Element description: Participant administration.................................................................................84

<AdminData>................................................................................................................................ 84

<User>.......................................................................................................................................... 84

<LocationRef>............................................................................................................................... 85

<Location>.................................................................................................................................... 85

<SignatureDef>............................................................................................................................. 85

7.8 Element description: Clinical data......................................................................................................86

<ClinicalData>............................................................................................................................... 86

<SubjectData>.............................................................................................................................. 86

<Annotation> - Subject.................................................................................................................. 86

<StudyEventData>........................................................................................................................ 87

<FormData>.................................................................................................................................. 88

<AuditRecord>.............................................................................................................................. 88

<Signature>.................................................................................................................................. 88

<Annotation>................................................................................................................................. 89

<ItemGroupData>.........................................................................................................................89

<Annotation>................................................................................................................................. 90

<ItemDataTyped>.........................................................................................................................90

<ItemData>................................................................................................................................... 90

<ImageData>................................................................................................................................ 91

<ImageFileData>........................................................................................................................... 91

<Annotation>................................................................................................................................. 91

<Annotations>............................................................................................................................... 93

8. Appendix A-1: SAS program example.......................................................................................................94

9. Appendix A-2: SAS format (=code lists) example....................................................................................133

10.Appendix B: SPSS syntax example.........................................................................................................141

11.Appendix C: CDISC ODM v1.3 example.................................................................................................229



1. Introduction

Data stored through the secuTrial® DataCapture may be exported to external files in various formats from theExportSearchTool. The export is started by the user and generated asynchronous on the server. The filecontaining the exported data is at first stored on the application server. This file is encrypted for theintermediate storage using a five digit random TAN (transaction number) which is only known to the personwho started the export. After completion of the export, the data file can be downloaded from the server usingthe TAN for access.

As the export generation is done asynchronous, you can start several exports, logout and login later todownload the results. To get informed when the exports are finished you can be notified by e-mail.

All data of the patients entered in the eCRFs are exported. Further related data may be exported using theavailable options in the ExportSearchTool.

The data may be exported in various formats. These are:

SAS

SPSS

CSV / text files

CDISC ODM

All exported data are delivered as zip files to minimize download time. These files have to be unpackedbefore they may be imported into the required application.

The zip-files contain a varying amount of files:

CDISC ODM v1.3 (XML): 6-9 files (1 *.xml for the data and 5-8 *.xsd file for description of formats)

SAS: 1 *.sas, 1 *_fmt.sas file, all tables in separate files named *.dat in the subdirectory "dat".

SPSS: 1 *.sps file, all tables in separate files named *.txt in the subdirectory "dat"

CSV and text-format: all tables in separate files (forms and subforms, according audit trails-tables; additionally casenodes, forms, items, questions, visit plan, visit forms, centres, queries, comments, sdv, separate table with reference values [some might be missing according to the chosen export options])

Images

If the project setup and the chosen option (“Included data: project setup”) includes separate image data ascollected with an image item all exported files are included into a separate "patientimages" folder (withfurther substructure). The names and path of the included files are listed in the exported "images" table.

Images and image items are not included in the rectangular export format.

New features in secuTrial® 5.1

There are no changes regarding the export in this version.

1.1 Export Options

Several options can be set to define which data are to be exported. The range of options varies if the exportis started directly or on the result of a search. It depends further on the project configuration and selectedexport format.

The selected options are included on a html page into the export zip file.



Fig. 1: Upper page part of the possible options for exports (format CSV format for MS Excel).

Fig. 2: Extended display for the selection of single or multiple items instead of all items to be included.



Fig 3: Lower page part for possible options for export. The filter for data records can be hidden from view if not needed.

Description

You can enter a short description for your export. This entry is optional. It shall help to distinguish thegenerated exports in the download or history list. If you omit this information (or in older exports) the list ofselected centre is displayed.

Project and Centre

The project and centres for which the data should be exported must be selected. The displayed optionsdepend on the role and assignment of the user. If the export is started as a search result only the foundpatients are included and the options for project and centre selection are disabled.

Visit

The data could be restricted for the included visits. Normally the whole visit plan is included but that could berestricted to include only the first or last visit (calculated individually for each patient regardless of visit type)or a single visit type could be selected. If the single visit is repeated in a patients visit plan, all visits of thistype will be exported. eCRFs of adverse events or general patient status are always included.

Patients

The patient data to be exported may be restricted to valid patients. Valid patients are all those patients whoare participating in the study and have not been dismissed from the study for reasons such as withdrawalfrom the study, death, etc. This is stored in the patient status: The patient status could have been set to"dead", "frozen" or "anonymized". None of those patients will be exported if you choose the option "Validpatients" but will be included with the option "All patients".

If you start an export after a search or from the display of a historical search result only the displayedpatients will be exported without further check for centres or status (see below).



Patients which are to be deleted completely or from the selected project will never be exported regardless ofthe chosen options.

Format

There are 6 different export formats available:

CDISC ODM v1.3 format (xml)

SAS format

SPSS format

CSV format for MS Excel

CSV data

Text file with fixed field lengths

Depending on the chosen format more options are available to specify it: For normal CSV format the fieldseparator and encloser could be assigned, in the MS Excel format the tabulator is used as separator anddouble quotes as encloser.

For the SAS and SPSS format additional files describing the data and starting the import in the statisticalapplication are created. These files are intended to be executed in the evaluation program to load allexported data in one or two steps.

For both CSV formats and the text file the handling of the code list could be specified. The reference valuescould either be exported in a separate file or the codes could be directly replaced by the coded value in thesame (form) table.

In the CDISC format some additional information could be included into the export by choosing the "withsecuTrial® Extensions" option. The format of the single data item could be chosen between the current 1.3and the older 1.2 ODM format. For further information see chapter: "CDISC ODM 1.3

Rectangular table

For SAS, SPSS, CSV and TXT the rectangular format can be choosen. For each patient there will beexactly one data row with all forms. Repeated data e.g. forms shown in multiple visits will be exported asrepeated columns.The repetition will be indicated be appropriate column names (see table description insection “6.24 data “ below).

With this format all code lists are automatically included in the data table for CSV and TXT format. Forthe explanation of the column names there are always one or two additional tables included in theexport. The visitplan (vp) explaines the used visit IDs.The formnames (fa) are only needed in the SASformat and describes the replacement of the tablenames with numbers, necessary because of thecolumn name length restriction in this program.

Duplicate form meta data into all tables

This option is not available for CDISC format and the rectangular option has not been chosen. Theduplication of meta data will repeat all meta data specified below in the section "Included data" to berepeated in all patient-related tables when appropriate. The amount of repeated columns will alsodepends on the existing project setup. For example: when there is no randomization used in the projectno randomization columns will be repeated (see explanation before the table descriptions for moredetails).

Shorten table names

Normally all names (standard and eCRF tables) are appended by the project model suffix and thetimestamp of the export, e.g. "casenode_TPX_20071105-183214.csv". For SAS tables the timestamp isonly appended to the included *.dat files, not to the table names itself.

For the SAS, SPSS, CSV and TXT format the option "shorten table names" can be selected. In this casethe standard tables are exported with only short names. Names of eCRF tables are abbreviated byremoving the "mnp" and project model suffix from the table name. The prefix for audit trail and subformtables will be maintained.

WARNING: If there are any naming conflicts between custom and standard tables, the later exportedtables will be renamed by adding a number suffix!



In the rectangular export format this option removes the timestamp from the name and shortens thenames of the additional explanation tables. The project abbreviation remains.

Included data

Patient identifier

In all export files patients are identified by the internal unique patient identifier (=DB-primary key). Alongwith this identifier, the pseudonym and the additional identification code (=AID) to identify the patient inthe export data may be exported. The possible choices depend on the project usage of these identifiers.

Centre information

Centre information may be included in the export data. The centre is exported in a separate table,containing the name of the centre and the country. For CDISC export this option is always enabled tocreate valid ODM files.

The participant information is now included with the document edit meta information (see below).

Project setup

A short description of the defined forms of the selected project including the project visit plan can beexported by choosing this option. For CDISC export this option is always enabled to create valid ODMfiles.

This option is not available for rectangular export formats.

Queries and Comments

Queries and Comments may be included in the export data.


Source Data Verification (SDV)

The validation of the electronic data against the original source is stored in two separate tables (one forthe current form data and one for the audit trail) which can be exported by choosing this option. The SDVstatus of each document is included into the export even if this option is not chosen. In the CDISC formatthe SDV status is added either as an additional attribute (with iAS extension) or as separate annotations(without iAS extension).

This option is only available if the usage of SDV is configured for the selected project. This option is notavailable for rectangular export formats.

Missing Values (MV)

The markup of missing values is stored in two separate tables (one for the current form data and one forthe audit trai) which can be exported by chossing this option, the audit trail MV table only when the audittrail option is additionaly selected. The markup of missing values is not exported within CDISC format.

This option is only available if the usage of MV is configured for the selected project. This option is notavailable for rectangular export formats.

Audit Trail

A complete audit trail may be exported along with the valid current patient data.


Double Data Entry

This option is only displayed for projects which uses double data entry.

Normally only the original records where the double data entry comparison has been finished areexported. You can choose to include the duplicates (in the DataCapture visible from the original audittrail) or the double records before finished comparison to be included into export.


Images



If any image item is included into the project setup these option let you include the original (uploaded),the displayed (web) and/or the thumbnail image to the export. Besides the image description table whichis always exported, the option included the separate image files into the export. These files are exportedin the separate "patientimages" folder.

This option is not available for rectangular export formats. Images and image items are not exported inthe rectangular format.

E-Signature and validation

Some information about the e-signature including the signature-validity of every eCRF may be includedin the export data. The validation is done during the time of the export.

A new algorithm for creating e-signatures has been introduced in secuTrial® 3.1 to handle problems withsigning subforms. The algorithm version is stored in each document to allow the validation of both (oldand new) types of e-signatures. If the validation option has been choosen, this version is exported too.

This option is only available if the usage of e-signature is configured for the selected project.

Form data of hidden fields

Instead of the deletion of items, questions or complete eCRFs with the risk of non-tolerable data-lossthese elements can be marked as "hidden" in the FormBuilder. Even visit forms, not shown in any visitare treated as hidden. Hidden elements will not be displayed in the DataCapture for collecting anddisplay of data but the data are preserved in the database and can still be exported (per selection foreach export) and evaluated.

If the export option “include hidden data” is selected for export of SAS / SPSS / CSV or TXT format, eventhe data related to hidden fields will be exported. If any element in a project is marked as "hidden" thedescription of the project-setup contains an additional column for this property. The hidden data of theform description, queries, comments, sdv or forms will be marked as “hidden” in a therefore introducedcolumn “hidden”, resp. “mnphide” in form data tables.

In the CDISC format the form description and queries and comments on hidden elements are onlyexported if this option is chosen. Here the "hidden" property is exported as an annotation to the eCRFdata. The form data are filtered as chosen by this option.

NOTE: It is not possible to export any data of visit forms not shown in any visit with the rectangularformat because with this structure all forms must be assigned to a distinct visit to create thedistinct columns!

Form items

Since secuTrial 4.3 it can be selected weather the complete eCRFs or only selected items shall beexported. Non-displayed (=hidden) items can only be selected if the option “Form data of hidden fields”has been selected. Single items, formgroups, forms or formfamilies can be selected. At least one itemmust be selected to start an export with item selection.

In the non-rectangular export only those tables will be exported, that includes one of the selected items.

This option is not selectable for the CDISC format. For this format the complete project setup will alwaysbe exported.

Form meta data

The meta information about form and patient status, document editing an eCRF-structure can be in- orexcluded from the export. This can reduce the amount of additional columns if this information is notneeded for data evaluation.

The specific description of the columns belonging to the meta categories can be found in the online helpor in the annotations of the mnp* and data table descriptions below.

Data handling

Unselected checkbox

The value of unselected checkboxes can exported as “0” (as in previous versions) or “null”. In eithercases it is not possible to distinguish between not stored eCRF with checkbox and stored eCRF withunselected checkbox values.

Date / time items



To allow the handling of eCRF date / time items as real dates during evaluation it is now possible to letthis value be exported in “real” date format. Because most evaluation software only accept completedates and times, not given parts has be completed with a default value. The default can be specifiedhere.

For further details about the exported date and time formats in the selected export format see theappropriate sections about “Date formats”.

Randomization

If the project configuration includes the configurable randomization with blinding and the participant hasthe unblinding export right, there is an option to unblind the randomization during export. With this optionselected the additional randomization columns in the casenode table (or the additional RANDOM form inthe CDISC ODM format) will include the random groups whereas the normal randomization form itemswill always be exported the blinded randomization value.

The unblinding will be logged in the export history.

Filter data records

The included eCRFs are filtered by these options. A data row (one stored eCRF) will not be exported if theattributes stored in the congruent mnp-document (e.g. "form is complete") are not the same as specified inthe filter options. The default value - “no check” – means not to filter by this option. The filter checks alloptions with an AND qualifier.

The options and values are:

Completion status: no check / empty / partly filled / completely filled

Validation: no check / without / with warning

Validation: no check / without / with error

Review A: no check / no / yes

Review B: no check / no / yes

Freeze (by system): no check / no / yes

Comment status: no check / without / with comment

Query status: no check / open / answered / resolved Query

Source Data Verification: no check / not done / in progress / verified with errors / not necessary / verified

The filter applies to the current data in the eCRFs, if the audit trail option has been choosen, all audit trailrecords for all exported current records are exported. Therefore the actual status information of the audittrails records can be different from the filter selection.

Send email

You can be notified if the export has been finished. If your email contact is already known in secuTrial ® theaddress field will be pre-filled.

1.2 Export after Search

Additionally search results can be exported. The data selection options "project" and "centre" are thereforenot available, because the subjects whose data are to be exported are determined before the export isstarted on the result of the search.

Only patients displayed in the search result will be exported. That means the applied filters on the searchresult will apply on the export too. On the other hand all forms matching the export filter will be exported; thedata is not restricted to that included in the search form.

Patients, who shall be deleted completely or in the chosen project, will never be exported.



2. Export Model

This section describes all possible tables and columns that SAS export files may contain. Some tables andcolumns are optional, see chapter: "Export Options".

2.1 Standard (non-rectangular) structure

For reasons of simplification, some tables in secuTrial® are joined into one table. Like this, the secuTrial®

database model is transformed to a more flat model. The following picture illustrates the exported tables in atable-relationship model. A table is shown with its keys and major columns. The number of tables of entities“<tablename>”, “<sub-tablename>” and "<at-tablename>", "<at-sub-tablename>" depends on the project(study).

Some of the tables could be omitted for an export depending on chosen export configuration. The columns inthe “<tablename>” entities vary depending on the fact, if the eCRF has been collected during a normal visit,an adverse event or directly connected to the casenode. The exact declaration for these three categories canbe found in the table descriptions.

The structuring into administrative data, study setup and eCRF data is only an informal structure concerningthe table contents. This structure is not explicitly found in the export.

Fig. 4: Structure of the exported data in the standard (non-rectangular) format. The black arrows depictthe relationships between the tables. The orange arrows indicate the content relations to the tableand column names from the form setup to the eCRF data.


Study Setup

vpform

mnpvisid <fk>formid <fk>

Administrative Data

eCRF Data

casenode

mnppid <pk>mnpctrid <fk>...

centre

mnpctrid <pk>...

visitplan

mnpvisid <pk>...

questions

fgid <pk>formid <fk>...

forms

formid <pk>formtablename...

items

ffid <pk>fgid <fk>ffcolname...

<tablename>

mnpdocid <pk>mnppid <fk>mnpvisid<fk>...(ffcolname)…

<sub-tablename>

mnpsubdocid<pk>mnpdocid <fk>...(ffcolname)…

<at-sub-tablename>

mnpatsubdocid <pk>mnpatdocid <fk>fgid <fk>...(ffcolname)…

queries

mnpdocid <fk>ffid <fk>ffcolnamemnpqueryid…

<at-tablename>

mnpdocid <fk>mnpatdocid<pk>mnppid <fk>mnpvisid <fk>...(ffcolname)… comments

mnpdocid <fk>ffid <fk>ffcolnamemnpcommentid…


2.2 Rectangular structure

In the rectangular export format all casenode and eCRF data are exported into a single “data” table. Foreach patient there is exactly one data row. The tables structure of single eCRFs are then concatenated.Repeated display of forms, like eCRF shown in several visits, are then appended as additional columns.

The form types are concatenated in the sequence:

1. visit forms2. casenode forms3. adverse event forms4. image forms

Patient visits are sorted by visit type as defined in the project visit plan. Visit repetitions are in immediatesuccession. Visit groups or treatment arms are neglected in the export. For each visit all shown forms areincluded.

Adverse events and follow-ups are repeated and counted according creation, starting with 1. For each follow-up all adverse event forms are included regardless if they are shown for a single patient (adverse eventforms may be filtered according the “is SAE” property of the single event).

Image forms are also repeated and counted according creation per image form. The assignment to patientsvisit or follow-up are only indicated by the export of the corresponding mnpcvpid (=primary key of the patient-visit) or mnpfuid (primary key of the adverse event follow up). If both key columns are empty then the imageform was assigned to the patient directly.

According to the form definition the user defined items are listed for each form. To distinguish the columnsfrom separate eCRFs the columns are prepanded by an appropriate name prefix. Subforms are repeated asoften as the maximal number for each export. The item repetitions are marked by appending repetitionindizes (see below).

Scheme of column names for visit forms

Example v21_1_mnptp0table_column[_1_1]Visit: listed by primary key, here with visitid = 21Visit repetition: 1Table: mnptp0table ('mnp' + project scheme + user entered value), for SAS format the

tablesnames are replaced by a number to avoid too long column names. The replacement is documented in the formnumbers table.

Column: column name as defined per user (eCRF item) or meta data (see table descriptions)

Optional for sub forms: ID of Repetitiongroup-question and number of repetition

Scheme of column names for casenode forms

Example c_mnptp0table_column[_1_1]Table: mnptp0table ('mnp' + project scheme + user entered value)Column: column name as defined per user (eCRF item) or meta dataOptional for sub forms: ID of Repetitiongroup-question and number of repetition

Scheme of column names for adverse event forms

Example: a1_3_mnptp0table_column[_1_1]Adverse event number: counted by existance per patient, here = 1Repetition/Followup: counted by existance per patient, here = 3Table: mnptp0table ('mnp' + project scheme + user entered value)Column: column name as defined per user (eCRF item) or meta dataOptional for sub forms: ID of Repetitiongroup-question and number of repetition

Scheme of column names for image forms

Example i5_mnptp0table_column[_1_1]Image form: repetition: 5Table: mnptp0table ('mnp' + project scheme + user entered value)Column: column name as defined per user (eCRF item) or meta dataOptional for sub forms: ID of Repetitiongroup-question and number of repetition

If the option “shorten table names” have been selected, the “mnptp0” part of the form names are removedfrom the column names.



If an eCRF is not stored or created for a single patient the corresponding columns are empty. The structureof the complete table may differ depending on the included patient data: only the maximal number orrepetitions in the exported data, not in the complete project data, are displayed.

For the explanation of the visit-IDs in the column names the standard table visitplan is additionaly included inthe export. In the SAS format the form table names are replaced by a simple form number. To explain thereplacement an additional table formnumbers is exported too.

Fig. 5: Structure of the exported data in the rectangular. The orange arrows indicate the content relationsto the name parts of the column names from the setup to the eCRF data. The table “formnumbers”is only exported in the SAS format, for all other formats the respective table names are useddirectly as part of the column names.


Study SetupeCRF Data

visitplan

mnpvisid <pk>...

formnumbers

formnumberformtablename

data

v21_1_mnpdocidv21_1_mnpptnid <cl>v21_1_mnpcvpidv21_1_mnpvispdt...v21_1_(ffcolname)…

a1_1_mnpdocida1_1_mnpptnid <cl>a1_1_mnpfuida1_1_mnpaedt...a_1_(ffcolname)…

mnpcnid <pk>mnpctrid <cl>mnpptnid <cl>mnpcs0 <cl>…

i1_mnpdocidi1_mnpptnid <cl>i1_mnpcvpidi1_mnpfuidi1_mnpfs0 <cl>...i1_(ffcolname)…

mnpdocidmnpptnid <cl>mnpfs0 <cl>...(ffcolname)…


3. SAS-Format

3.1 Introduction

By selecting the appropriate export format, all data are exported in a SAS compatible format. At least twofiles are created for the export, one containing table meta-data and clinical data definition, the othercontaining the code lists. The naming convention for these files is: the file name is an abbreviation of theproject name with the file extension ".sas“. The code lists file has the additional naming extension"*_fmt.sas".

The sas file contains all data descriptions, the data records are separate files. All names of tables in theexport have the name of table as they are stored in the secuTrial® database. These data tables are includedin a separate directory "dat" and have the file extension ".dat". The names follow the convention:

the prefix 'at' for audit records

the prefix 'mnp' for normal data records, the prefix 'emnp' for repetition data records

the project abbreviation, e.g. 'tp0'

a representative short table name, e.g. 'persondata'

The naming of these files follows the naming convention described above, extended with the projectabbreviation and the timestamp of the export, similar to the naming of the entire zipped download file. Thesenames are referenced in the sas script file. This naming convention avoids mixing data from differentexports.

Some older SAS versions only allow table names with eight characters. In order to achieve this, the codingconvention prefixes apart from the prefix ‘at’ and 'e'' (subforms) may be omitted from the export names, byusing the export option "shorten table names".

The data descriptions have INPUT and ATTRIB definitions of all variables. The INPUT label defines thename of all variables in the record and the start position and the end position of data in the record. All alpha-numerical fields are identified with a dollar-sign ($) before the start position. Date field input definitions arecharacterized by starting with an at-sign (@) followed by the start position of the date and then the fieldname.

The ATTRIB attributes contain a label for each variable, format details for code list elements, format andinformat details for date variables.

In the rectangulare export format there are exactly three data files: data, visitplan and formnumbers. Theproject abbreviation is always appended to the data files, an additional timestamp is appended if the option“shorten tablenames” has not been selected.

3.2 Data types

Date Formats

All date fields edited in the eCRFs (iAS date components) are stored as strings in the database with theformat YYYYMMDDHHMISS.

YYYY is a four digit year value, e.g. 1956

MM is a month as number (01 for January; 12 for December)

DD is the day of the month

HH is the time in 24 hours

MI is the minute value of the time

SS is the second’s value of the time.

Other system generated dates are stored in a real data format in the database.

SAS has no data type for date times that is capable to specify the time zone. Two types of SAS date formatsare used: DATETIME20 and DATE9. These formats are used to represent all internal dates stored in thesystem, such as last edit date, creation date, etc.

The time zone of all exported dates and datetimes is specified in the configuration file of the secuTrial®

installation.



It is possible to export the item dates as “real” dates. Then they will be exported similar to th e systemgenerated date and times. For the display in SAS the FORMAT for these variables are specified to simulatethe input display in the eCRFs. The “real” date formats are listed in the second row for each iAS datecomponent.

If exporting as “real” date all values not entered in the eCRF are replaced by the defaults given during exportstart. It is not therefore not possible to distinguish if a user has left a minor part of a non-checked date itemempty or if the part could not be entered because of the item type.

Type iAS FormatSAS INFORMAT SAS FORMAT Format Description Example

Date (e.g visit date) DATE11. DATE9. DD-MMM-YYYY 28-MAY-2004

Date-time

(e.g. last edit date)

DATETIME20. DATETIME20. DD-MMM-YYYY:HH:MI:SS 28-MAY-2004:11:58:03

iAS

date com

ponents

YYYY $4 YYYY 2004

DATE11. YEAR4. DD-MMM-YYYY 01-01-2004

MM-YYYY $6 YYYYMM 200405

DATE11. MONYY7. DD-MMM-YYYY 01-MAY-2004

DD-MM-YYYY $8 YYYYMMDD 20040528

DATE11. DATE9. DD-MMM-YYYY 28-MAY-2004

DD-MM-YYYYHH:MM

$12 YYYYMMDDHHMI 20040528115800

DATETIME20. DATETIME20. DD-MMM-YYYY:HH:MI:SS 28-MAY-2004:11:58:00

HH:MM $4 HHMI 1158

TIME8. HHMM5. HH:MI:SS 11:58:00

HH:MM:SS $6 HHMISS 115803

TIME8. TIME8. HH:MI:SS 11:58:03

MM:SS $4 MISS 5803

TIME8. TIME8. HH:MI:SS 00:58:03

iAS

calculated date tim

e intervals

Y $4 YYYY 0052

Y-M $6 YYYYMM 001202

Y-M-D $8 YYYYMMDD 00020503

Y-M-D-H-M $12 YYYYMMDDHHMI 000205031205

H-M $12 YYYYMMDDHHMI 000205031205

H-M-S $14 YYYYMMDDHHMISS 00020503120512

M-S $14 YYYYMMDDHHMISS 00020503120512

Because there are no display type for minutes and seconds only, this item type is formatted as a completetime if exported as “real” date.

Because of the three-letter month abbreviation it is possible to select the language for the date format.Probably most SAS installation will need the date-language in english.

Other Data Types

Other used SAS data types are Strings ($8, $10, $20, $40 … $100) and Numbers (4. == 4 digits).



The investigator data will be exported as code lists. In the rectangular data the centre and countryinformation are also exported as code lists, in the standard format this information is exported in a separatetable.

Most status data are exported as bit values which may be seen as Boolean values. The value 1 indicatesthat the bit is set and that the status is "valid" or "true". Status values "0" or NULL indicate that the bit is notset and that the corresponding status is "false". The meaning of all bit values are stored in the appropriatecode list.

The data lines all have fixed length fields. Between each pair of fields, one field is left empty. This makes iteasier to assess the file. Position rules with the variable names are provided as comments in the data file ifconfigured via configuration file. This again is just a convenience to be able to examine the file manually.

Labels

Every table and each item of the form (which build the variable parts of the variables) have assigned a labeltaken from the form (=eCRF) declaration as done in the secuTrial® FormBuilder. The label of the wholeeCRF is taken from the form name (the displayed name in the matrix).

The label of each item is made up of the item label. If this is not set, the question label is used. If this label isnot set either, the unique label as for the search is used, which must be set at least.

Code Lists

Code lists are exported to a separate file with the name extension 'fmt'. The reference of which field haswhich code list is defined in the FORMAT value of the ATTRIB specifiers. The following items are exportedas code lists:

Status values. These are most binary values which only have one key/value pair for the value "1". Some status values are coded by a small amount of values.

Checkbox values. Checkboxes may only be set or not set, like a binary value. In the data table, the value1 represents "set". The coding of the value is stored in the code lists, and quite like the binary status values, may only have two key/value pair. The standard value is "yes" or "no". Per export option it is possible to export the non-set state as “null” (unset column = spaces).

Drop down selections. All choices of the drop down are coded in the code list.

Radio-button choices. All choices of a radio-button group are coded in the code list.

Query, answer, comment, sdv code lists. The type of the annotation to an eCRF.

Investigators. All investigators referenced in export data are coded in code lists. These are only exportedif investigator and centre data are to be exported at all.

Centre and country names. These are only exported for the rectangular format.

Images

With the image component files of any format can be uploaded to the server. This function is intended to beused to collect associated images to a study. Therefore besides storing the uploaded file on the server thesystem tries to generate a web image for display on the eCRF and a thumbnail for compressed display. Allthree images (if existent) can be included into the export and will be stored into a separate image folder.

As an eCRF item the image will be exported as a reference to the separate table "images" containing someinformation about the image as origin name, file size, file type, upload date and user who uploaded theimage.

In the rectangular format image items and image data are not included, even if “all items” has been selected.

Numbers

In secuTrial® there are integer (without) and double (with decimal digits) number items. These items will beexported with the specified input precision.

Score number fields are exported with the length of 22 digits. The actual length of the calculated scorenumber is nevertheless be the same as displayed length in the DataCapture and depends on the calculationalgorithm and item configuration.



The used decimal digit character can be defined by specifying the number format language in the exportoptions.

3.3 SAS Format Problems

Problem: Data lines in SAS longer than 256 are truncated at 256 bytes and an error may be generated see[http://support.sas.com/techsup/unotes/SN/004/004448.html].

To avoid this problem SAS advise to follow one of two options:

Place data in an external file and specify this file in the INFILE statement. This allows the LRECL (logicalrecord length, the maximum length of a record) to be specified. The appropriate length of each statementis calculated by secuTrial®.

Alternatively, split the data lines, so that each line contains less than 256 bytes. This is not possible if thedata fields themselves are longer then 256 bytes, for example with queries, answers and comments. However, data of lines that are longer than 256 bytes may be wrapped to the next line. This is indicated in the input statement of the SAS file by the line pointer control character "/".

Because text areas in secuTrial® can consist of more than the allowed length, only the first option isimplemented since secuTrial® 2.0.

Since SAS version 9.1 it is possible to disable the option “QuoteLenMax” in the “fmt” script (export option“Ignore warnings for 262 character length“). Because the code list labels are originally not defined in SAS butin various secuTrial® places, they could exceed the SAS limitations.


http://support.sas.com/techsup/unotes/SN/004/004448.html


4. SPSS Format

4.1 Introduction

The SPSS export consists of different files in one zip file with a similar structure as the SAS export. One*.sps syntax file describes the imported tables and columns and a "dat" folder contains the csv-data files.

The data files are simple csv-format as described in the next chapter. The single columns are enclosed indouble quotation marks and are separated by single commas.

In the data files the column names are listed in the first line which is omitted during the syntax execution butcan be used for manual inspections. In the syntax files the columns are labelled with the specified text for theSAS export (see table description for details) or the item labels as defined in the FormBuilder for the eCRFlayout.

4.2 Data types

The medical data entered into the eCRFs are exported either as whole or rational number with defined lengthor as text. The length of text depends on the input field. The meta data information such as visit plan date orsave timestamps are exported as real dates or datetimes. The length of number data are either defined bythe number of the form item field for standard number fields or by constants used for coding values.

Date formats

It is possible to export the item dates as “real” dates. Then they will be exported similar to the systemgenerated date and times. For the display in SPSS for these variables FORMATS are specified to simulatethe input display in the eCRFs. The “real” date formats are listed in the second row for each iAS datecomponent.

If exporting as “real” date all values not entered in the eCRF are replaced by the defaults given during exportstart. Therefore it is not possible to distinguish if a user has left a minor part of a non-checked date itemempty or if the part could not be entered because of the item type.


installation.

Type iAS FormatSPSS INFORMAT SPSS FORMAT Format Description Example

Date (e.g visit date) DATE DATE9. DD-MMM-YYYY 28-MAY-2004

Date-time

(e.g. last edit date)

DATETIME DATETIME23.2. DD-MMM-YYYY HH:MI:SS 28-MAY-2004 11:58:03iA

S date

components

YYYY A4 YYYY 2004

DATE MOYR9 DD-MMM-YYYY 01-01-2004

MM-YYYY A6 YYYYMM 200405

DATE MOYR9 DD-MMM-YYYY 01-MAY-2004

DD-MM-YYYY A8 YYYYMMDD 20040528

DATE DATE11 DD-MMM-YYYY 28-MAY-2004

DD-MM-YYYYHH:MM

A12 YYYYMMDDHHMI 20040528115800

DATETIME DATETIME23.2. DD-MMM-YYYY HH:MI:SS 28-MAY-2004 11:58:00

HH:MM A4 HHMI 1158

TIME TIME5 HH:MI:SS 11:58:00

HH:MM:SS A6 HHMISS 115803

TIME TIME8. HH:MI:SS 11:58:03

MM:SS A4 MISS 5803

TIME TIME8. HH:MI:SS 00:58:03



Type iAS FormatSPSS INFORMAT SPSS FORMAT Format Description Example

iAS

calculated date tim

e intervals

Y A4 YYYY 0052

Y-M A6 YYYYMM 001202

Y-M-D A8 YYYYMMDD 00020503

Y-M-D-H-M A12 YYYYMMDDHHMI 000205031205

H-M A12 YYYYMMDDHHMI 000205031205

H-M-S A14 YYYYMMDDHHMISS 00020503120512

M-S A14 YYYYMMDDHHMISS 00020503120512

Because there are no display type for minutes and seconds only, this item type is formatted as a completetime if exported as “real” date. There is no FORMATS type in SPSS for year only, so this item type isformatted similar to the month-year item.

Because of the three-letter month abbreviation it is possible to select the language for the date format.Probably most SPSS installation will need the date-language in english.

Code Lists

Coded values such as radio button, popup, lookups, checkboxes as well as status values and participantreferences are exported as coded values with defined value labels containing all corresponding possiblevalues.

The following items are exported as code lists:

Status values (F2.0)These are most binary values which only have one key/value pair for the value "1". Some status values are coded by a small amount of values. The length for this fields are F2.0

Checkbox values (F2.0)Checkboxes may only be set or not set, like a binary value. In the data table, the value 1 represents "set". The coding of the value is stored in the code lists, and quite like the binary status values, may only have two key/value pair. The standard value are "yes" and "no".

Drop down selections ("popup" items)(F10.0)All choices of the drop down are coded in the code list.

Radio-button options (F10.0)All options of a radio-button group are coded in the code list.

Query, answer, comment, sdv status code lists (F2.0)The type of the annotation to an eCRF.

Investigators (F10.0)All investigators referenced in export data are coded in code lists. These are only exported if investigatorand centre data are to be exported at all.

Centre and country names (F10.0). These are only used for the rectangular format.

Images


As an eCRF item the image will be exported as a reference to the separate table "images" containinginformations about the image as origin name, file size, file type, upload date and user who uploaded theimage.



In the recangular format image items and image data are not included, even if “all items” has been selected.

Numbers

The number format in SPSS depends on the system locale of the SPSS installation. As this could be setduring the import it would change the setting permanently. So the number format can be chosen before theexport creation in secuTrial® independently of the module or project configuration to match the SPSS systemused for evaluation.



5. CSV & Text Formats

5.1 Introduction

The CSV-Format (Character Separated Values) is a very flexible export format, and many systems supporttheir import: Microsoft Excel, OpenOffice.org Calc, Oracle, SPSS. A disadvantage of this format against SASand CDISC is that no meta-data such as labels and descriptions of fields may be exported. The CSV andText formats are described together here. They only vary slightly in the formatting of the data lines.

Three export selections are available for these formats:

CSV Format for MS Excel

CSV Data

Text files with fixed field lengths.

Fig. 6: Possible encloser types for the CSV export format.

The CSV formats use variable field lengths. The data fields are enclosed with field enclosure characters andare delimited by another character. The MS-Excel format uses a tabulator "(Tabulator)" as field separatorand double quotation marks as field enclosure characters. In the CSV data format these delimiters may bealtered (see possible selection as shown above). In the text file format with fixed field lengths, all fields areexported with fixed field lengths and no field delimiters are used, similar to the SAS dat-file format.

Each table is exported to a separate file. The file name has the name of the table. Reference values may beexported to separate tables or to the same table. When exported to the same table, the code is replaced. Ifexported to a separate file, they are all exported to one file, with the naming convention „cl_“+ projectabbreviation.

Column names may be exported; these will be exported to the first line of each file.

5.2 Data types

Date Formats

It is possible to export the item dates as “real” dates. Then they will be exported similar to the systemgenerated date and times. The “real” date formats are listed in the second row for each iAS date component.It is not possible to specify a distinct display format in CSV or TXT files. This has to be done manually in theused software if desired.

If exporting as “real” date all values not entered in the eCRF are replaced by the defaults given during exportstart. It is not therefore not possible to distinguish if a user has left a minor part of a non-checked date itemempty or if the part could not be entered because of the item type.


installation.

Type iAS Format Format Description Example

Date (e.g visit date) YYYY-MM-DD 2004-05-28

Date-time

(e.g. last edit date) YYYY-MM-DD HH:MI:SS 2004-05-28 11:58:03

YYYY YYYY 2004



Type iAS Format Format Description Example

iAS

date com

ponents

YYYY-MM-DD 2004-05-28

MM-YYYY YYYYMM 200405

DD-MMM-YYYY 2004-05-28

DD-MM-YYYY YYYYMMDD 20040528

DD-MMM-YYYY 2004-05-28

DD-MM-YYYY HH:MM YYYYMMDDHHMI 20040528115800

DD-MMM-YYYY HH:MI:SS 2005-05-28 11:58:03

HH:MM HHMI 1158

HH:MI:SS 11:58:00

HH:MM:SS HHMISS 115803

HH:MI:SS 11:58:03

MM:SS MISS 5803

HH:MI:SS 00:58:03

iAS

calculated date tim

e intervals

Y YYYY 0052

Y-M YYYYMM 001202

Y-M-D YYYYMMDD 00020503

Y-M-D-H-M YYYYMMDDHHMI 000205031205

H-M YYYYMMDDHHMI 000205031205

H-M-S YYYYMMDDHHMISS 00020503120512

M-S YYYYMMDDHHMISS 00020503120512

Code Lists

Code lists could be exported to a separate file with the name "cl_" + project-abbreviation if the option“separate table” is chosen. Otherwise the db-values of code lists would be replaced by the referenced(label-) values during export. The three columns contain information about "column", "code", and "value".The column is described by table name + "." + column name. The code consists of the db-value to beinterpreted, and the value represents the meaning of the code. The following item types are referenced in thecode list:

Binary status values. These only have one key/value pair for the value "1“.

Status values for status with more than one option.

Checkbox values. Checkboxes may only be set or not set, like a binary value. In the data table, the value"1" represents "set". The coding of the value is stored in the code lists and like the binary status values may only have two key/value pair. The value is "yes" or "no" possibly appended by label following the checkbox display in the form.

Drop down selections. All choices of the drop down are coded in the code list.

Radio-button choices. All choices of a radio-button group are coded in the code list.

Queries, sdv: The type of annotation to an eCRF.

Investigators. All investigators referenced in export data are coded in code lists. These are only exportedif investigator and centre data are to be exported.



If an item references a lookup table and the reference values are exported into separate files the values ofthe lookup table are referenced by this lookup table name in contrast to simple code list values of radiobuttons which are referenced by table- and column name of the item. The information which lookup table hasto be used for an item is given in the "lookuptablename" column of the item-description.

With the rectangular table format the option “separate table” cannot be chosen and all values will be directlyexported inline in the data table.

Images


As an eCRF item the image will be exported as a reference to the separate table "images" containing someinformation about the image as origin name, file size, file type, upload date and user who uploaded theimage.

In the rectangular format image items and image data are not included, even if “all items” has been selected.

Numbers

The number format can be chosen before the export creation in secuTrial® independently of the module orproject configuration to match the software system used for evaluation.



6. Table descriptions

The following table description generally applies in structure and content to the SAS, SPSS and the CSV /TXT formats. The Label descriptions are only applicable for the SAS or SPSS export format. The SASLength/ Format description is only applicable for the SAS export format. The SPSS Format descriptions areonly applicable for the SPSS export format.

For simple CSV or TXT format only the variable names are exported and even that only if the correspondingoption (“column names”) has been chosen.

6.1 Explanations for variable description flags

The numerical or letter flags in the first columns of the export table descriptions mark variables that are onlyexported if project configuration and export options match specific criteria. These flags are explained here.

0: Patient's pseudonym

This variable includes one of the patient's pseudonym. The available pseudonyms depend on the project'sconfiguration. The available pseudonyms can be selected separatly to be included.

1: Centre information

This variable is only exported if the export option "Centre information" has been chosen.

2: Document editing

This variable is only exported if the export option form meta data "Document editing" has been chosen. Itcontains information about author (investigator or patient user) and edit date. The variable for the patientuser is only exported if the project uses the "patient reported outcome" (PRO) workflow. In that case eitherparticipant or patient could have made one entry. In that case for each line either participant or patientusewill be set, not both.

3: Structure information

This variable is only exported if the export option form meta data "structure information" has been chosen.This information includes event (visit / adverse event) dates or event numbering.

v: Visit or image eCRF

Visit eCRFs additionally have these variables of the Case Visit Plan of every patient. The labels of the visitsand other meta-data are exported in a separate table, see [section Visit Plan].

As image eCRFs could be related to either patient, single visits or adverse event follow-ups these tables willhave all possible visit columns too.

a: Adverse Event or image eCRF

Adverse Events are occasions when a patient visits the physician for a medical reason outside of the regularvisit plan of the trial (according GCP: “Any untoward medical occurrence in a patient or clinical investigationsubject administered a pharmaceutical product and which does not necessarily have a causal relationshipwith this treatment.”). The indication of the irregular visit, for example flu, is the Adverse Event. All furtherirregular visits to the physician for the same indication are follow-ups to the initial Adverse Event.

As image eCRFs could be related to either patient, single visit or adverse event follow-up these tables willhave all possible adverse event columns too.

i: Image eCRF

Image eCRFs did not follow a study plan. They can be created using the predefined forms by every participant with the edit right and can be related to patient, visit or adverse event follow-up. These variables define the creator (participant) and creation date.

4: E-Signature and validation

This variables are only exported if the e-signature is used and the option “E-signature with validation” hasbeen chosen.

5: Hidden data

This variable is only exported if there are any hidden fields in the project and the option "Form data of hiddenfields" has been chosen.



6: Patient status

This variable is only exported if the export option form meta data "patient status" has been chosen.

7: Form status

These variables are only exported if the export option form meta data “status” has been chosen. Theycontains information about the completion and review status of a form document.

8: Image files

These variables includes the file names of the included image (binary) files. Which of the three possible files(original, web-display, thumbnail) are included depends on the distinct selection. If a value could be exporteddepends on the file's type (only real images can be manipulated to create a web display and thumbnailimage).

d: Double data entry

This variable is only exported if there is any double data entry form in the project.

m: Duplication of meta data

This variables will only be exported if the additional format option "Duplicate meta data in all tables" has beenchosen. This variables are also restricted by the other options listed above.

r: Randomization

This variable(s) is (are) only exported if the project contains any configurable randomization. The variablename and label of this information depends on the definition of the randomization button item. The variablefor the random number ('no') is only added if the randomization is blinded. The "rdm" part of the columnname is replaced by the random column name specified in the randomization form.

t: DTM

This variable is only exported if the workflows of the project include the discrepancies handling (DTM).

p: Patient information

For form tables: This variable is only exported if the table includes patient form related information only.

c: Centre information

This variable is only exported if there are any centre forms specified in the project and the table eithercontains centre form data or the content could be related to patient or centre form data (e.g. for queries).

6.2 visitplan /vp (Project visit plan)

This table is exported if the option "Project setup" was included. The primary key of the visit (‘mnpvisid’) isreferenced in every visit related eCRF.

This table is always exported in the rectangular format as an explanation for the the column visit numbers.

In the productive area the visitplan of the current, productive project and all archived project versions areexported, the version information is included in the last two columns. In the setup area these columns will beempty. Only if a project has just been set to released but the release has not been performed the versioninformation of the next productive version is included there.

Variable Label SAS Length/Format

SPSSFormat

Description

mnpvisid Visit-ID 10 F10.0 Identifier of the visit. Used in eCRF Data as reference to the Visit Plan.

visitnumber Visit sequence 10 F4.0 Sequence of visit creation

visittype Type of visit 2[clvt.]

F2.0 Type of visit (scheduled/unscheduled, type of date check)[ 0 = 'fixed' 1 = 'flexible' 2 = 'unscheduled' 3 = 'free']




SPSSFormat

Description

previsid Preceding visit-ID 10 F10.0 Reference to the preceding visit (needed for calculation of visit date)

visitday Time lag to precedingvisit (days)

10 DATE11 The visit plan date is calculated by the date from the preceding visit (seeabove) and this time lag.

minusoffset Possible negative time frame (days)

10 F10.0 For some visit types it is possible to give a time frame around the calculated visit day where a visit is allowed. This defines the days beforethe visit plan date.

plusoffset Possible positive timeframe (days)

10 F10.0 For some visit types it is possible to give a time frame around the calculated visit day where a visit is allowed. This defines the days past the visit plan date.

visitarm Treatment arm $100 A100 Name of the treatment arm if this visit is dedicated to an arm.

visitgroup Visit group $100 A100 Name of the visit group if this visit is included into a (repeated) visit group.

5 hidden hidden in DataCapture

2[clhd.]

F2.0 A status setting indicating that this visit is hidden in the DataCapture.[ 0 = 'no' 1 = 'yes']

mnpvislabel Visit label $50 A50 (Individual) visit label that is shown inthe patient's form overview.

mnpvsno Version number 10 F10.0 Version number of project (will only be set in productive area).

mnpvslbl Version label $30 A30 Version label of project (will only be set in productive area)

6.3 visitplanforms / vpfs (Forms shown in visits)

This table is exported if the option "Study setup" was included. It only consists of the two foreign keys of visitand form, indicating which form is presented in which visit. This can be used to check if every presented formis stored for a patient.


SPSS Format Description

mnpvisid Visit-ID 10 F10.0 Identifier of the visit. Used in eCRF Data as reference to the Visit Plan.

formid Form-ID 10 F10.0 Identifier of the Form-Definition.

6.4 forms / fs (Forms)

All forms are exported to one table. This is exported if the option "Project setup" was included.

An eCRF in secuTrial® is based on a form definition which is set up in the FormBuilder and stored in thedatabase too. A short form setup description is exported too in three tables: "forms", "questions" and "items".The eCRF setup is structured hierarchically: 'form' <-->> 'question' <-->> 'item'. One eCRF is described withone form (and stored into one db table). The questions are mainly for layout purpose but connect also to thesubforms. The items itself reflects the single db column. In queries and comments the items are referencedby id and Colum name.



For subforms the question-ID of the parent-repetition is exported to distinguish between double referencedsubforms in the same parent form (e.g. medication in the morning and medication in the evening, recorded inone form "medication").

The 'hidden' column is only present for projects which contain at least one 'hidden' element (either form,question or item).

In the productive area the forms of the current, productive project and all archived project versions areexported, the version information is included in the last two columns. In the setup area these columns will beempty. Only if a project has just been set to released but the release has not been performed the versioninformation of the next productive version is included there.

The variables for forms are:

Variable Label SAS Length[Format]


formid Form-ID 10 F10.0 Unique identifier of the form.

formtablename DB table name $24 A24 The table name for the form-data. This table name is used in the export as the (part) filename too.

5 hidden hidden in DataCapture 2[clhd.]

F2.0 A status setting indicating that this form is hidden in the DataCapture[ 0 = 'no' 1 = 'yes']

fornname Form name (as in matrix)

$200 A100 This name is used in the patient matrix to identify an eCRF. Most times it will be the same as the titleof the opened eCRF.

formfamily Form family name $100 A100 Name of the form family as displayed in the matrix.

sequence Form sequence in form family

10 F10.0 Sequence of form in the form family. This field is used for numerical sorting.

d ddetype DDE form type 2[cldde.]

F2.0 A flag indicating that this form is used as a double data entry form.[ 0 = 'normal form'

1 = 'DDE form' ]

mnpvsno Version number 10 F10.0 Version number of project (will onlybe set in productive area).

mnpvslbl Version label $30 A30 Version label of project (will only be set in productive area).

6.5 questions / qs (Questions)

This table is exported if the option "Project setup" was included. Questions are the intermediate levelbetween forms and items. This level is used in secuTrial® mostly for layout purpose. Often it does contain thequestion text of the eCRF.

The 'hidden' column is only present for projects which contains at least on 'hidden' element (either form,question or item).

The variables for questions are:


SPSSFormat

Description

fgid Question-ID 10 F10.0 Unique identifier for the question. This ID is referenced in the QAC table.

formid Form-ID 10 F10.0 Identifier of the form, foreign key to the forms table.

formtablename DB table name $24 A24 The table name for the form-data. This table name is used in the export as the (part) filename too.




SPSSFormat

Description

fornname Form name (as in matrix)

$200 A100 This name is used in the patient matrix to identify an eCRF. Most times it will be the same as the title of the opened eCRF.

sequence Question sequence in form

10 F10.0 Sequence of question in the form as used for sorting. This may not be filled or may not simply be incremented. This field is nevertheless used for numerical sorting.


2[clhd.]

F2.0 A status setting indicating that this form is hidden in the DataCapture.[ 0 = 'no' 1 = 'yes']

fglabel Question label (or unique label for search)

$200 A200 The text of the question in the form. If this is not set, the unique label for search is used (which must be set at least in the FormBuilder)

subform-tablename

Sub-form DB table name

$24 A24 The table name for the subform data. This column is only filled for repetition form groups.

6.6 items / is (Items)

This table is exported if the option "Study setup" was included. All Items are exported to one table. One itemcorresponds to a single data field in the eCRF. Sometimes the textual descriptions are stored in the questionlabel (see above); therefore the exported label could be the same as the label of the question itself.

The 'hidden' column is only present for projects which contains at least on 'hidden' element (either form,question or item).

The variables for items are:


SPSSFormat

Description

ffid Item-ID 10 F10.0 Unique identifier for the item.

fgid Question-ID 10 F10.0 Identifier for the question, foreign key toquestions. This ID is referenced in the QAC table.

m fglabel Question label (or unique label for search)

$200 A200 The text of the question in the form. If this is not set, the unique label for search is used (which must be set at least in the FormBuilder)

m formid Form-ID 10 F10.0 Identifier of the form, foreign key to the forms table.

m formtablename DB table name $24 A24 The table name for the form-data. This table name is used in the export as the (part) filename too.

m fornname Form name (as in matrix)

$200 A100 This name is used in the patient matrix to identify an eCRF. Most times it will be the same as the title of the opened eCRF.

sequence Item sequence in question

10 F10.0 Sequence of items in the question as used for sorting. This may not be filled or may not simply be incremented. This field is nevertheless used for numerical sorting.

ffcolname DB column name $32 A32 Identifier of the form, foreign key to the forms table.




SPSSFormat

Description

itemtype Item component type

$200 A200 The name of the assigned item component type.


2[clhd.]

F2.0 A status setting indicating that this form is hidden in the DataCapture[ 0 = 'no' 1 = 'yes']

fflabel Item label (or question label or unique label for search)

$1500 A1500 The text of the item in the form. If this isnot set, the question label or at least theunique label for search is used (which must be set in the FormBuilder)

unit Unit / additional text

$200 A200 This text is displayed after the input element. It often describes the measurement unit of a number variable.

lookuptable name of lookup table

$30 A30 If the column refers to it the name of theLookup table is inscribed

d ddecomp Comparison type for DDE

2[clddecomp.]

F2.0 A status describing the type of comparison for DDE. [ null/0 = 'compare' 1 = 'ignore' 2 = 'ignore case and whitespace' (only text) 3 = 'compare including hash values' (only images)]

6.7 deactivatedcodes / dc (Deactivated Codelists Options)

This table is exported if the option "Project setup" was included. This table is only exported if there are anydeactivated code list entries at all in the project or the exported data. This table describes which code listoptions are deactivated and in which project version this was done. Code list items are either of type radiobutton, popup or lookup.

The variables for deactivated code list options are:



codelist Code list $30 – Name of the code list. This column is only exported in the SAS format because all other formats do not use code list names.

formtablename DB table name

$25 A24 The name of the form (for radio button and popup items).

column Column $30 A30 The name of the form column (for radio button and popup items).

lookuptable Name of lookup table

$30 A30 The name of the lookup table (for lookup items).

value Value 10 F10.0 Coded value of code list entry.

label Label $200 A200 Label of the code list entry.

version Version $100 A100 Version label of the project where the entry was (last) deactivated.

versiondate Version date DATETIME20 DATETIME23.2Version timestamp of the project where the entry was (last) deactivated.

6.8 centres / ctr (Centres)

This table is exported if it is chosen to export "Investigator and centre" option. All centres of the project areexported. The primary key of the centre "mnpctrid" is then referenced in every casenode.

The variables for centres are:





mnpctrid Centre-ID 10 F10.0 The identifier of the centre.

mnpctrname Centre name $100 A100 The name of the centre.

mnpcname Country name $200 A200 The name of the country.

6.9 casenodes / cn (Patient information)

This table contains the basic information about the exported patients. Various casenode identifiers may beexported, if they are available in the system. Each patient is identified with a unique primary key. Theparticipant referenced here is the person responsible for the patient inclusion into the given project (neededfor payment).

A patient pseudonym or an additional identifier (=AID) also uniquely identifies a patient. This need not beexported though. The selection option for this depends on the project configuration.

Patients with the status set to "to-be-deleted" will never be exported. Patients with the status "deletepseudonym" will be exported if the option "all patients" have been chosen. Otherwise these patients will beomitted too.

The casenode table will be extended with the columns of the configurable randomization items as defined inthe project. If the column names are not unique across the project the column names will be prefixed with thetable name.

The variables for casenode are:


SPSSFormat

Description

mnppid Patient-ID 10 F10.0 Identifies each patient uniquely. This identifier is a unique number which each patient record receives automatically and can not be altered.

0 mnppsd Patient pseudonym

$20 A20 The random patient pseudonym. This identifier may not be exported.

0 mnpaid Patient identifier

$20 A20 An alternative patient identifier which may be entered when the patient is stored. This identifier may not be exported.

0 mnplabid Patient identifier

$20 A20 An alternative patient identifier which is given when the patient is created. This identifier may not be exported.

r mnp_rdm_no Label of the randomizationitem + "no"

$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type.This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.

r mnp_rdm_gr Label + "group"

$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type.This column is exported if the randomization is blinded, the unblinded option has been selected for the export or some patients have been unblinded permanently due to an emergency.

2 mnpcnptnid Participant-ID 10[cltn.]

F10.0 The identifier of the user who entered the patient into the project. Investigators are exported as code lists and the identifier is the key of the code list.

1 mnpctrid Centre-ID 10 F10.0 The identifier of the centre. This information is not exported if centre data are not to be exported. Centres are exported as separate tables and this identifier is the primary key of thattable.




SPSSFormat

Description

m1mnpctrname Centre name $100 A100 The name of the centre.

6 mnpcs0 Case status 0 2[clcs_0x.]

F2.0 A status setting indicating that the patient record is not valid.[ 1 = 'not shown']


F2.0 A status setting indicating that the patient record has been marked as being anonymized (no pseudonym). [ 1 = 'delete Pseudonym']


F2.0 A status setting indicating that the patient record data is frozen and may not be changed. This status is not used at the moment; therefore it is not distinguished from the next.[ 1 = 'data frozen']


F2.0 A status setting indicating that the patient record has been frozen automatically, set by rule [ 1 = 'data frozen']


F2.0 A status setting indicating that the patient has deceased. [ 1 = 'deceased']


F2.0 A status setting indicating that the patient data in this project is frozen and may not be changed.[ 1 = 'Project: data frozen]


F2.0 A status setting indicating that the patient data in this project will be deleted. [ 1 = 'Project: to be deleted']


F2.0 A status setting stating that no new visits may be added for this patient in this project. [ 1 = 'Project: closed visit plan']

3 mnpvisstartdate Entry date DATE11. DATE11 Date of patient entry into the project. Base for thecalculation of the patients visit plan.

6.10 atcasenodes / atcn (Patient information history)

The audit trail tables of the patient visit plans are divided into two tables: 'atcn' and 'atcvp' which are exportedwith the "Audit trail" option. For casenodes the entry dates could be changed to adjust the base of the visitplan.



mnppid Patient-ID 10 F10.0 Identifies each patient uniquely. This identifier is a unique number which each patient record receivesautomatically and can not be altered.

m0 mnppsd Patient pseudonym


m0 mnpaid Patient identifier $20 A20 An alternative patient identifier which may be entered when the patient is stored. This identifier may not be exported.

m0 mnplabid Patient identifier $20 A20 An alternative patient identifier which is given when the patient is created. This identifier may not be exported.





mr mnp_rdm_no Label of the randomization item + "no"

$100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.

mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.

m2 mnpcnptnid Participant-ID 10[cltn.]

F10.0 The identifier of the user who entered the patient into the project.Investigators are exported as codelists and the identifier is the key of the code list.

m1 mnpctrname Centre name $100 A100 The name of the centre.

m3 mnpvisstartdate Entry date DATE11. DATE11 Date of patient entry into the project. Base for the calculation of the patients visit plan.

oldvisitstartdate Old entry date DATE11. DATE11 Former entry date before change of visit plan.

newvisitstartdate New entry date DATE11. DATE11 New date after the change of visit plan.

2 mnpptnid Participant-ID 10[cltn.]

F10.0 The identifier of the user who made the change of the entry date.Investigators are exported as codelists and the identifier is the key of the code list.

2 mnppusid Patientuser-ID 10 F10.0 Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table.

changedate Date of change DATETIME20 DATETIME23.2 Timestamp of change.

changereason Reason for change

$200 A200 Reason given by user.

6.11 atcasevisitplans / atcvp (Patient visit plan history)

The audit trail tables of the patients case visit plans are divided into two tables: 'atcn' and 'atcvp' which areexported with the "Audit trail" option. Patient visits could be changed in the planned visit date or - forunscheduled visits - in the visit type.



mnppid Patient-ID 10 F10.0 Identifies each patient uniquely.This identifier is a unique number which each patient record receives automatically and can not be altered.





m0 mnppsd Patient pseudonym $20 A20 The random patient pseudonym. This identifier may not be exported.

m0 mnpaid Patient identifier $20 A20 An alternative patient identifier which may be entered when thepatient is stored. This identifier may not be exported.



$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded or the centre-assignment of random numbershas been selected.

mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.




m3 mnpvisstartdate Entry date DATE11. DATE11 Date of patient entry into the project. Base for the calculationof the patients visit plan.

mnpcvpid Patient visit-ID 10 F10.0 Unique identifier for the visit of a patient. If the visit has been deleted, this column is empty.

oldmnpvispdt old planned date of visit

DATE11. DATE11 Former plan date before change of visit plan.

newmnpvispdt New planned date of visit

DATE11. DATE11 New plan date after the change of visit plan. If the visit has beendeleted, this column is empty.

oldmnpvisid Old visit-ID 10 F10.0 If the type of an unscheduled visit was changed, this is the former visit type.

newmnpvisid New visit-ID 10 F10.0 If the type of an unscheduled visit was changed, this is the new visit type. If the visit has





been deleted, this column is empty.

oldmnpvisno Old patient-visit number

10 F10.0 The patient-visits are counted inthe sequence of their creation, starting with 1. The counting is independently for the scheduledand unscheduled visits. Unscheduled visits are counted individually be type. If a visit type was changed, the absolutenumbers and sequences have to be adjusted. The former number is stored here.

newmnpvisno New patient-visit number

10 F10.0 The patient-visits are counted inthe sequence of their creation, starting with 1. The counting is independently for the scheduledand unscheduled visits. Unscheduled visits are counted individually be type. If a visit type was changed, the absolutenumbers and sequences have to be adjusted. The new number is stored here. If the visit has been deleted, this column is empty.


F10.0 The identifier of the user who made the change of the visit. Investigators are exported as code lists and the identifier is the key of the code list.

2 mnppusid Patientuser-ID 10 F10.0 Patient ID if the patient has made the change instead of theparticipant, references the mnppid from the casenode table.

changedate Date of change DATETIME20. DATETIME23.2Timestamp of change.

changereason Reason for change $200 A200 Reason given by participant.

6.12 atadverseevents / atae (Patient's adverse event and follow-up history)

The audit trail tables of the patients adverse events and follow-ups are included into one table: 'atae' whichis exported with the "Audit trail" option. Patient adverse events and follow-ups could be changed in the dateor - for adverse events - in the adverse event number.



mnppid Patient-ID 10 F10.0 Identifies each patient uniquely. This identifier is a unique number which each patient record receives automatically and can not be altered.

m0 mnppsd Patient pseudonym $20 A20 The random patient pseudonym. This identifier may not be exported.





m0 mnpaid Patient identifier $20 A20 An alternative patient identifier which may be entered when the patient is stored. This identifier may notbe exported.



$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.

mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.


F10.0 The identifier of the user who entered the patient into the project. Investigators are exported as code lists and theidentifier is the key of the code list.


m3 mnpvisstartdate Entry date DATE11. DATE11 Date of patient entry into the project. Base for the calculation of the patients visitplan.

mnpaeid Adverse event-ID 10 F10.0 Unique identifier for the adverse event of a patient.

mnpaefuid Follow-up-ID 10 F10.0 Unique identifier of the follow-up of a patient. Only set for edited follow-ups.

olddate Old date DATE11. DATE11 Old date of adverse event or follow-up before editing. If theentry has been made for editing of adverse event (mnpaefuid is empty), this refers to the adverse event. If the entry has been made for editing of a follow-up





(maneaefuid is set), this referes to the follow-up date.

newdate New date DATE11. DATE11 New date of adverse event or follow-up after editing. If the entry has been made for editing of adverse event (mnpaefuid is empty), this refers to the adverse event. If the entry has been made for editing of a follow-up (maneaefuid is set), this referes to the follow-up date.

oldmnpaeno Old patient adverse event number

10 F10.0 The patient-adverse events are counted in the sequence of their creation, starting with 1. If the chronological sequence had been change the sequence could have been adjusted. The former number is stored here.

newmnpaeno New patient adverse event number

10 F10.0 The patient-adverse events are counted in the sequence of their creation, starting with 1. If the chronological sequence had been change the sequence could have been adjusted. The new number is stored here.


F10.0 The identifier of the user who made the change of the visit. Investigators are exported as code lists and the identifier is the key of the code list.

2 mnppusid Patientuser-ID 10 F10.0 Patient ID if the patient has made the change instead of the participant, references themnppid from the casenode table.

changedate Date of change DATETIME20. DATETIME23.2 Timestamp of change.

changereason Reason for change $200 A200 Reason given by editing user.

6.13 queries / qac (Queries)

This table is exported if it is chosen to export "queries and comments" option.

Queries and comments are annotations to the eCRFs. Each eCRF may have multiple queries andcomments. One query can consist of many questions and answers. At last a query is resolved with a finalremark. Resolved queries consist at least of one question, one answer and one final remark. Queries areplaced upon single items in the form.

The variables for queries are:



mnppid Patient-ID 10 F10.0 The unique patient identifier associatinga query record to a patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the query was made on a centre-form).







m0 mnpaid Patient identifier


m0 mnplabid Patient identifier




mr mnp_rdm_gr Label + "group"

$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patienthas been unblinded permanently due toan emergency.

m2 mnpcnptnid Participant-ID

10[cltn.]

F10.0 The identifier of the user who entered the patient into the project. Investigatorsare exported as code lists and the identifier is the key of the code list.



m3v mnpvislabel Visit label $50 A50 (Individual) visit label that is shown in the patient's form overview.

m3v mnpvispdt Planned dateof visit

DATE11. DATE11 The planned date of the visit. For a fixed visit this date is predefined by the visit plan. For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant.

m3a mnpaedate Adverse Event date

DATETIME20. DATETIME23.2The date when the Adverse Event occurred.

m3a mnpaeno Adverse Event casenumber

10 F10.0 Individual number of the Adverse Event for the given casenode. This number is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events.

m3a mnpaefuid Adverse Event Follow-up-ID

10 F10.0 The ID of a follow-up to the Adverse Event.

m3a mnpaefudt Adverse Event Follow-up date

DATETIME20. DATETIME23.2The date when the patient data was collected for the follow-up.

m3i mnpcrtdt Document create date

DATETIME20. DATETIME23.2The date of the creation of this document.





mnpdocid Document-ID 10 F10.0 Unique identifier of the eCRF to which this annotation has been added. As queries could be added on normal items or item in subforms, this is either the mnpdocid from the outer form or themnpsubdocid from the inner form.

ffid Item-ID 10 F10.0 Identifier for the item, foreign key to table "items".

ffcolname DB column name

$32 A32 Column name of the item.


2[clhd.]

F2.0 A status setting indicating that this query is hidden in the DataCapture because either item, question, form or visit is hidden.[ 0 = 'no' 1 = 'yes']

qacdate Date of entry DATETIME20. DATETIME23.2The date when the annotation was edited.

mnpqueryid Query-ID 10 F10.0 Unique identifier of a query. This field indicates which answer belongs to which question.

t querytype Query Type (Manual or Automatic)

$1 A1 The type indicates if the query is the result of an automatically check (via discrepancies) or entered directly into the form. [A = 'Automatical' M = 'Manual']

querystatus Query Status(Calculated Status)

2

[clqa.]

F2.0 The result status of the actual sequenceof queries and answers (= the status of the last query-entry). If the query is based on an automatic check (type="A"), then the final resolve could be marked for a new check. The last option is only available if the setup includes the discrepancies handling (DTM).[ 0 = 'no entry' 1 = 'Query' 2 = 'Answer' 4 = 'Resolved' 8 = 'Resolved and check again']

qacstatus QAC Status (type of query-entry)

2[clqa.]

F2.0 The status of the single query entry. The type is the same as the result status of the whole query (see above).

2 mnpptnid Participant-ID

10

[cltn.]

F10.0 The identifier of the user. Investigators are exported as code lists and the identifier is the key of the code list.

qaccontent Content $1000 A1000 The content of the annotation.

6.14 comments / cts (Comments)

This table is exported if the "queries and comments" option has been selected.

Comments are annotations to the eCRFs. Each eCRF may have multiple comments. The comments aresingle, unrelated remarks to single items.

The variables for Comments are:





mnppid Patient-ID 10 F10.0 The unique patient identifier associating a comment record to a patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the comment was made on a centre-form).


$20 A20 The random patient pseudonym. Thisidentifier may not be exported.






$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of thistype. This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.

mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of thistype. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.


F10.0 The identifier of the user who enteredthe patient into the project. Investigators are exported as code lists and the identifier is the key of thecode list.




m3v mnpvispdt Planned date of visit



DATETIME20. DATETIME23.2 The date when the Adverse Event occurred.


10 F10.0 Individual number of the Adverse Event for the given casenode. This number is calculated during the creation of an Adverse Event, it does not necessarily represent the





temporal order of events.




DATETIME20. DATETIME23.2 The date when the patient data was collected for the follow-up.


DATETIME20. DATETIME23.2 The date of the creation of this document.

mnpdocid Document-ID 10 F10.0 Unique identifier of the eCRF to which this annotation has been added. As comments could be addedon normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form.





2[clhd.]

F2.0 A status setting indicating that this comment is hidden in the DataCapture because either item, question, form or visit is hidden.[ 0 = 'no' 1 = 'yes']

qacdate Date of entry DATETIME20. DATETIME23.2 The date when the annotation was edited.

mnpcommentid Comment-ID 10 F10.0 Unique identifier of a Comment.


F10.0 The identifier of the user. Investigators are exported as code lists and the identifier is the key of thecode list.

qaccontent Content $1000 A1000 The content of the annotation.

6.15 sdv / sdv (Source Data Verification)

This table is exported when the selected project has this function configured and the corresponding exportoption was chosen. For every item there could be an entry in this table stating the state of SDV. If there is noentry, the item has the default status "not done". If the value of an SDV for an item or form has changed, theold values will be transferred in to the SDV audit trail table (see down).




c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the SDV was performed on a centre-form).







mr mnp_rdm_no Label of the $100 A100 Randomization similar to the form table





randomization item + "no"

with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.


$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patienthas been unblinded permanently due to an emergency.


10[cltn.]


m1 mnpctrname Centre name

$100 A100 The name of the centre.




DATE11. DATE11 The planned date of the visit. For a fixedvisit this date is predefined by the visit plan. For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant.











mnpdocid Document-ID

10 F10.0 Unique identifier of the eCRF on which the SDV has been performed. As SDV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form.









2[clhd.]

F2.0 A status setting indicating that this queryis hidden in the DataCapture because either item, question, form or visit is hidden.[ 0 = 'no' 1 = 'yes']

sdvdate Date of entry DATETIME20 DATETIME23.2 The date when the SDV was performed.

mnpfssdv Status SDV 2[clfssdv.]

F2.0 Status of the referenced item.[ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred' 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors' ]


10[cltn.]


6.16 atsdv / atsdv (Source Data Verification audit trail)

This table is exported when the selected project has this function configured and the SDV and audit trailexport option was chosen. For every item there could be an entry in this table stating the former state ofSDV. If there is no entry, the item has the default status "not done".




c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the SDVwas performed on a centre-form).


$20 A20 The random patient pseudonym. Thisidentifier may not be exported.







mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been





unblinded permanently due to an emergency.


F10.0 The identifier of the user who enteredthe patient into the project. Investigators are exported as code lists and the identifier is the key of thecode list.




m3v mnpvispdt Planned date ofvisit












mnpatdocid ATDocument-ID

10 F10.0 Unique identifier of the audit trail eCRF on which the SDV has been performed. As SDV could be done onnormal items or item in subforms, thisis either the mnpdocid from the outer form or the mnpsubdocid from the inner form.





2[clhd.]

F2.0 A status setting indicating that this query is hidden in the DataCapture because either item, question, form orvisit is hidden.[ 0 = 'no' 1 = 'yes']

sdvdate Date of entry DATETIME20 DATETIME23.2 The date when the SDV was performed.

mnpfssdv Status SDV 2[clfssdv.]

F2.0 Status of the referenced item.[ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible'





8 = 'deferred' 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors']


F10.0 The identifier of the user. This information is not exported if investigator data are not to be exported. Investigators are exported as code lists and the identifier is the key of the code list.

6.17 miv / miv (Missing Values)

This table is exported when the selected project has this function configured and the corresponding exportoption was chosen. For every item there could be an entry in this table stating the state of Missing Values. Ifthere is no entry, the item has the default status "Value exists". If the value of an MV for an item haschanged, the old values will be transferred in to the MV audit trail table (see down).




c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the MV was performed on a centre-form).










$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.


F10.0 The identifier of the user who entered the patient into the project. Investigators are exported as code lists and the identifier is the key of thecode list.




















mnpdocid Document-ID 10 F10.0 Unique identifier of the eCRF on which the MV has been set. As MV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form.





2[clhd.]

F2.0 A status setting indicating that this query is hidden in the DataCapture because either item, question, form orvisit is hidden.[ 0 = 'no' 1 = 'yes']

editdate Date of entry DATETIME20 DATETIME23.2 The date when the MV was performed.

mivstatus Status MV 2[clmiv.]

F2.0 Status of the referenced item, label depends on project configuration.[ 2 = 'Value not collected' 3 = 'Other reason for missing value' 4 = 'Value not collected due to rule' ]

mivstatustext Other reason for MV

$250 A250 Other reason for missing value (freetext entry of user). May only be exported if project configured to use





this MV status.


F10.0 The identifier of the user. Investigators are exported as code lists and the identifier is the key of thecode list.

2 mnppusid Patientuser-ID

10 F10.0 10

6.18 atmiv / atmiv (Missing Values audit trail)

This table is exported when the selected project has this function configured and the MV and audit trailexport option was chosen. For every item there could be an entry in this table stating the former state of MV.If there is no entry, the item has the default status "Value exists".




c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the MV was performed on a centre-form).










$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.


10[cltn.]





m3v mnpvispdt Planned date DATE11. DATE11 The planned date of the visit. For a fixed





of visit visit this date is predefined by the visit plan. For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant.











mnpatdocid ATDocument-ID

10 F10.0 Unique identifier of the audit trail eCRF on which the SDV has been performed. As SDV could be done on normal items or item in subforms, this is either the mnpdocid from the outer form or the mnpsubdocid from the inner form.





2[clhd.]

F2.0 A status setting indicating that this queryis hidden in the DataCapture because either item, question, form or visit is hidden.[ 0 = 'no' 1 = 'yes']

editdate Date of entry DATETIME20 DATETIME23.2 The date when the MV was performed.

mivstatus Status MV 2[clmiv.]

F2.0 Status of the referenced item, label depends on project configuration.[ 2 = 'Value not collected' 3 = 'Other reason for missing value' 4 = 'Value not collected due to rule' ]

mivstatustext Other reasonfor MV

$250 A250 Other reason for missing value (freetext entry of user). May only be exported if project configured to use this MV status.


10[cltn.]


2 mnppusid Patientuser-ID

10 F10.0 10



6.19 mnp…: eCRF Data

The eCRF tables have names following the naming convention for short and long names described above.The audit records are stored in separate tables, and these have the same name as the table along with aconstant prefix 'at'. The audit tables have the same structure as the data tables, with an additional newprimary key. The original document is referenced by the original primary key.

The variable eCRFs have fixed and varying schema. Each eCRF table has the same fixed variables. Thevarying variables are eCRF dependent. The labels of the varying schema are taken from the form definitionas made in the FormBuilder. If the item label is set, this is used directly. If no item label is set, the questionlabel is used instead. If this is not set either, the unique label for search of the question is used, which mustbe set at least. If the item is the number part of a unit group, the standard unit is appended in brackets to thelabel.

Four types of eCRF record sets exist:

1. Data belonging to the casenode, independent of a visit. These eCRFs just have a reference to the patient casenode.

2. Data collected during patient visits. These eCRFs contain visit details. Each visit is identified by a visit-id.All records of one patient in the same visit have the same visit-id. For each patient the visits are numbered according creation sequence.

3. Data of Adverse Events and Serious Adverse Events. These eCRFs contain details of the Adverse Eventand Follow-up. For each patient the adverse events are numbered according creation sequence.

4. Data of image forms could be created without study plan and related to either patient directly or every single visit or adverse event follow-up. These forms depend on corresponding templates in the project setup and are therefore not necessarily included into every study.

Some of the standard variables depend on the selected options for export. These are commented in thedescriptions of the variables. Only a few variables depend on the overall project configuration as made in theFormBuilder or on the general setup of secuTrial®. These variables are explicitly stressed in the descriptionsbelow. (The order of description is approximately the order of export.)

Some eCRF variables are only exported for special types of forms. These variables are marked by numbersexplained below.



p mnppid Patient-ID 10 F10.0 The unique patient identifier associatingan eCRF record to a patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if this is a centre-form table).

pm0 mnppsd Patient pseudonym


pm0 mnpaid Patient identifier


pm0 mnplabid Patient identifier


pmr mnp_rdm_no Label of the randomizationitem + "no"


pmr mnp_rdm_gr Label + "group"

$100 A100 Randomization similar to the form table with the randomization button item. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient





has been unblinded permanently due toan emergency.

pm2 mnpcnptnid Participant-ID 10[cltn.]



pm3 mnpvisstartdate

Entry date DATE11. DATE11 Date of patient entry into the project. Base for the calculation of the patients visit plan.

mnpdocid Document-ID 10 F10.0 Each eCRF document record has a unique document identifier.

ddeduplicatedid

Document-ID of the duplicate document for DDE

10 F10.0 Document-ID of the duplicate documentfor DDE (only set if this is the original document). This column is only exported, if the project configuration includes the DDE function.

dderealdid Document-ID of the real document for DDE

10 F10.0 Document-ID of the real document for DDE (only set if this is the duplicate document). This column is only exported if the project configuration includes the DDE function.

2 mnplastedit Date of last edit

DATETIME20. DATETIME23.2Date when record was last edited (=saved).

2 mnpptnid Participant-ID 10

[cltn.]

F10.0 The identifier of the user who (last) saved the form. Investigators are exported as code lists and the identifier is the key of the code list.

2 mnppusid Patientuser-ID 10 F10.0 Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table. This column is only exported if the project configuration includes the PSD function.

p3v mnpvisid Visit-ID 10 F10.0 Identifier of the visit to which the eCRF belongs. This is the identifier for the common variables of the case visit plan.

3v mnpcvpid Patient visit-ID 10 F10.0 Unique identifier for each patient visit.

pm3vmnpvislabel Visit label $50 A50 (Individual) visit label that is shown in the patient's form overview.

p3v mnpvisno Patient visit number

10 F10.0 Individual number of visit for the given casenode. This number is calculated during the creation of the visit, it does not necessarily reflect the temporal sequence of visits. Scheduled and unscheduled visits are counted independently. Unscheduled visits are counted separate for each type.

p3v mnpvgrno Patient visit group number

10 F10.0 Individual number of repeating of group if the current visit is included in a (repeated) visit group.

p3v mnpvispdt Planned date of visit

DATE11. DATE11 The planned date of the visit. For a fixed visit this date is predefined by the visit plan. For flexible, free and





unscheduled visits this date is entered during the creation of a new visit by the participant.

p3v mnpvisfdt Date of first data entry in visit

DATETIME20. DATETIME23.2The date of first data entry. Normally this should be the real date of visit.

p3a mnpaeid Adverse Event-ID

10 F10.0 Unique identifier of an Adverse Event.

p3a mnpaedate Adverse Eventdate


p3a mnpaeno Adverse Eventcasenumber

10 F10.0 Individual number of the Adverse Eventfor the given casenode. This number is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events.

p3a mnpaefuid Adverse EventFollow-up-ID


p3a mnpaefudt Adverse EventFollow-up date


p3i mnpcrtdt Document create date


p3i mnpcrtpt Document creator (participant)

10

[cltn.]

F10.0 The user who creates this document. This information is not exported if investigator data are not to be exported.Investigators are exported as code lists and the identifier is the key of the code list.

p3i mnpcrtpusid Document creator (patientuser)

10 F10.0 The patientuser who creates this document. This is the Patient ID if the patient has made the change instead ofthe participant, references the mnppid from the casenode table. This column isonly exported if the project configuration includes the PSD function.

7 mnpfs0 Form status (Review A)

2[clfs_0x.]

F2.0 A status stating that the record has been reviewed with review level 1.[ 1 = 'medical reviewed(A)']

7 mnpfs1 Form status (Review B)

2[clfs_1x.]

F2.0 A status stating that the record has been reviewed with review level 2.[ 1 = 'data reviewed(B)']

7 mnpfs2 Form status (Freeze)

2[clfs_2x.]

F2.0 A status stating that the record is manually frozen and data may no longer be altered.[ 1 = 'manually frozen']

7 mnpfs3 Form status (System-Freeze)

2 [clfs_3x.]

F2.0 A status stating that the record is frozenby system and data may no longer be altered.[ 1 = 'rule based frozen']

7 mnpfcs0 Form completion status

2[clfs_0x.]

F2.0 A status indicating that the completion status of a record.[ 0 = 'empty' 2 = 'partially completed' 4 = 'completed']





7 mnpfcs1 Validation status (error)

2[clfs_1x.]

F2.0 A status stating that validation errors are stored in the record. [ 1 = 'with error']

7 mnpfcs2 Validation status (warning)

2

[clfs_2x.]

F2.0 A status indicating that confirmation warnings are stored in the record.[ 1 = 'with warning']

7 mnpfcs3 Data entry complete status

2[clfs_3x.]

F2.0 A status indicating the data entry on this record is completed. Further changes are only possible if queries aremade. This status is only exported, if the project configuration includes the DEC workflow.

7 mnpfsqa Form status Queries

2 [clfqa.]

F2.0 A status stating if any query or answered query is set on this record. If the status is set to 'Query' there is at least one open query on this record. If the status is set to 'Answer' than all existing queries on this record has beenanswered.[0 = '' 1 = 'with open query' 2 = 'with answered query' 4 = 'all queries resolved']

7 mnpfsct Form status Comments

2[clct.]

F2.0 A status stating if any comment has been made on this record.[1 = 'with comment']

7 mnpfssdv Form status SDV

2[clfssdv.]

F2.0 A status stating the progress of source data verification. This status is only exported, if the project configuration includes the SDV function.[ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors']

7 mnpfsdde Form status DDE

2[clfsdde.]

F2.0 A status describing the progress of the double data entry (DDE). This status is only exported, if the project configuration includes the DDE function.[ 0 = 'DDE comparison finished' 1 = 'entry in progress' 2 = 'entry completed' 3 = 'ignore' (duplicate)]

5 mnphide hidden in DataCapture

2[clhd.]

F2.0 A status setting indicating that this document is hidden in the DataCapture because either form or visit is hidden, or form is currently not shown in visit. This column is only exported if the project includes any hidden element.[ 0 = 'no' 1 = 'yes']





4 siguser Signature user $200 A200 Textual representation of the user:

TNTITEL+TNVORNAME + TNNACHNAME (of table PARTICIPANT). Only for validation purposes.

4 sigtext Signature text $30 A30 This is the textual description of the action leading to data storing. It is the same signature text that the user was presented during the signature process.It has been stored textually in the database as presented.

2 sigstatus Signature status

$2 F2.0 Numerical description of the action leading to data storing. This flag is always set, independent of any necessary e-signature. Meaning of values:

[ 1 = data edited 2 = review A 3 = review B 4 = comment 5 = query asked 6 = query answered 7 = data freeze 8 = data unfreeze 9 = sdv (only with SDV) 10 = revoke review A 11 = query resolved 12 = data entry complete (only DEC) 13 = modify data (only DEC) 14 = manual freeze 15 = data import 16 = revoke entry complete (only DEC) 17 = Query withdrawn 19 = DDE entry 20 = DDE entry completed 21 = DDE entry reopened 22 = DDE comparison finished 23 = DDE entry corrected 24 = revalidate]

4 sigvalid Signature validity

$10 A10 Validity of signature. This is only exported if chosen by option.[ valid invalid not signed ]

4 sigversion Signature algorithm version

2 F2.0 Numerical type of signature algorithm version.[0 = signature made before 3.1 1 = signature made since 3.1 2 = signature made since 4.0 ]

2 sigreason Reason for modification

$200 A200 Manually entered reason for modification of data after setting the "data entry complete" status. Required only for this action. This column is only exported if the project configuration includes the DEC workflow.

2 mnpvsno Version number

10 F10.0 Version number of the project with which the eCRF was stored (will only be set in productive area).

2 mnpvslbl Version label $30 A30 Version label of the project with which





the eCRF was stored (in the setup areathis is a timestamp of the last project setup editing).

6.20 atmnp…: Audit Trail eCRF

The tables of the audit trail are similar to the normal eCRF tables (see documentation above). Additionally,they have an own primary key "mnpatdocid". The reference to the original document is made via the"mnpdocid".



mnpdocid Document-ID 10 F10.0 The original eCRF document record unique document identifier.

mnpatdocid ATDocument-ID 10 F10.0 The unique identifier for the audittrail document itself.

6.21 emnp…: Sub-Documents

Fig. 7: Example of a repetition group with a subform. In this case there are no other items in the outer form.

eCRFs may contain repetition fields, which may have several values in one eCRF. An example is an eCRFwith medication. A patient often takes more than one type of medication, and these may be recorded usingrepetition fields. A repetition itself may contain many fields, in the medication example it might be theRegistered trademark, the Dose and Continuing it is taken. These data are stored and exported in separatetables, which contain a reference to the main eCRF.

Sub-document tables have the naming convention that all table names start with an 'e' for extended. If shortnames are to be used, the prefix is omitted from the table name.



p mnppid Patient-ID 10 F10.0 The unique patient identifier associating an eCRF record to a patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if this isa centre-subform table).

pm0 mnppsd Patient pseudonym


pm0 mnpaid Patient identifier $20 A20 An alternative patient identifier which may be entered when the





patient is stored. This identifier may not be exported.

pm0 mnplabid Patient identifier $20 A20 An alternative patient identifier which is given when the patient is created. This identifier may not be exported.

pmr mnp_rdm_no Label of the randomization item + "no"

$100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported ifthe randomization is blinded or the centre-assignment of random numbers has been selected.

pmr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported ifthe randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.

pm2 mnpcnptnid Participant-ID 10[cltn.]

F10.0 The identifier of the user who entered the patient into the project.Investigators are exported as code lists and the identifier is the key of the code list.

pcm1 mnpctrname Centre name $100 A100 The name of the centre.

pm3 mnpvisstartdate Entry date DATE11. DATE11 Date of patient entry into the project. Base for the calculation of the patients visit plan.

pm3v mnpvislabel Visit label $50 A50 (Individual) visit label that is shownin the patient's form overview.

pm3v mnpvispdt Planned date of visit

DATE11. DATE11 The planned date of the visit. For afixed visit this date is predefined bythe visit plan. For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant.

pm3a mnpaedate Adverse Event date


pm3a mnpaeno Adverse Event casenumber


pm3a mnpaefuid Adverse Event Follow-up-ID


pm3a mnpaefudt Adverse Event Follow-up date


pm3i mnpcrtdt Document create date


mnpdocid Parent document-ID

10 F10.0 The reference to the main (parent) document.





mnpsubdocid Subdocument-ID 10 F10.0 Unique identifier of the subdocument.

fgid Question-ID of Repetition

10 F10.0 Unique identifier of the repetition-question of the parent document.

position Position in Repetition

10 F10.0 Position in the repetition of the parent document starting with "0".

6.22 atemnp…: Audit Trail Sub-Documents

The audit trail tables of the sub-forms are exported in a similar way (see documentation above). In contrastto the audit trail of the normal eCRFs, the sub-documents do not reference the original sub-document butinstead reference the outer audit trail document. This is necessary because if a repetition was deleted priorto saving, there would be no original sub-document to refer to. Therefore the audit trail of the sub-documentscontains a new primary key and a new reference to the (audit trail) parent document.



p mnppid Patient-ID 10 F10.0 The unique patient identifier associating an eCRF record toa patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if this is a centre-subform table).

mnpatdocid Parent ATDocument-ID

10 F10.0 The identifier of the main (parent) audit trail document.

mnpatsubdocid ATSubdocument-ID 10 F10.0 The unique identifier for the audit trail subdocument itself.

fgid Question-ID of Repetition

10 F10.0 Unique identifier of the repetition-question of the parent (at)document.

position Position in Repetition 10 F10.0 Position in the repetition of theparent (at)document starting with "0".

6.23 images / img (Images)

If there are any images included into the eCRF data either in normal or special image forms, the imagereferences in the eCRF data are resolved in this separate image table. If the binary images are included intothe export, the corresponding file name and file status columns are appended to this table (see below).

The binary data are included in an "patientimages" folder inside the zip.



mnppid Patient-ID 10 F10.0 The unique patient identifier associating an eCRF record to a patient record.

c mnpctrid Centre-ID 10 F10.0 The identifier of the centre (if the image was uploaded in a centre-form).





m0 mnplabid Patient $20 A20 An alternative patient identifier





identifier which is given when the patient is created. This identifier may not be exported.


$100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded or the centre-assignment of random numbers has been selected.

mr mnp_rdm_gr Label + "group" $100 A100 Randomization similar to the form table with the randomization buttonitem. Depending on project setup there may be multiple columns of this type. This column is exported if the randomization is blinded, the unblinded option has been selected for the export or a patient has been unblinded permanently due to an emergency.


F10.0 The identifier of the user who entered the patient into the project.Investigators are exported as codelists and the identifier is the key of the code list.



m3v mnpvislabel Visit label $50 A50 (Individual) visit label that is shownin the patient's form overview.


DATE11. DATE11 The planned date of the visit. For afixed visit this date is predefined bythe visit plan. For flexible, free and unscheduled visits this date is entered during the creation of a new visit by the participant.




10 F10.0 Individual number of the Adverse Event for the given casenode. Thisnumber is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events.







mnpimgid Image-ID 10 F10.0 The unique identifier for the image.This ID is referenced in the eCRF tables.

uploadedfilename Uploaded file $500 A500 This is the original name from the client before the upload. As this is





not necessarily unique all files are renamed on the server and for export.

contenttype Content type $40 A40 Type of file as given by the uploading browser.

imagesize Image size (bytes)

22 F22.0 File size measured in bytes.

uploaddate Date of upload DATETIME20. DATETIME23.2 Timestamp of upload.

2 mnpptnid Participant-ID 10

[cltn.]

F10.0 The identifier of the user who uploaded the image. This information is not exported if investigator data are not to be exported. Investigators are exported as code lists and the identifier is the key of the code list.

2 mnppusid Patientuser-ID 10 F10.0 Patient ID if the patient has made the upload instead of the participant, references the mnppid from the casenode table. This column is only exported if the project configuration includes the PSD function.

8 originalfile Original file name

$100 A100 The file name of the uploaded file on the server resp. in the export.

8 originalstatus Status of original file

$15 A15 The status of the included original file.If the file is nonexistent this is an error for the original file as this should always exist.[ valid invalid nonexistent]

8 webfile Web file name $100 A100 For the display on the eCRF in the system a reduced web image could have been created during upload if possible for the uploaded file type.

8 webstatus Status of web file

$15 A15 The status of the included web file.

As the creation of a web image depends on file type a nonexistent web image could be valid. Possiblevalues:[ valid invalid nonexistent ]

8 thumbnailfile Thumbnail file name

$100 A100 For the display on report of patient matrix in the system a small thumbnail image could have been created during the upload if possible for the uploaded file type.

8 thumbnailstatus Status of thumbnail file

$15 A15 The status of the included thumbnail file.As the creation of a thumbnail image depends on file type a nonexistent web image could be valid. Possible values:[ valid





invalid nonexistent ]

6.24 data

This table is exported for the rectangular export format.


SPSS Format CSV /TXTLeng

th

Description

Patient

mnppid Patient-ID 10 F10.0 10 Identifies each patient uniquely. This identifier is a unique number which each patient record receives automatically and can not be altered.

0 mnppsd Patient pseudonym $20 A20 20 The random patient pseudonym. This identifier need not be exported.

0 mnpaid Patient identifier $20 A20 20 An alternative patient identifier which may be entered when the patient is stored. This identifier need not be exported.

0 mnplabid Patient identifier $20 A20 20 An alternative patient identifier


F10.0 150 The identifier of the user who entered the patient into the project. Investigators are exported as code lists and the identifier is the key of the code list.

CSV/TXT: full name of the participant,

Centre

1 mnpctrid Centre-ID 10 F10.0 200 The identifier of the centre.

CSV/TXT: name of the centre.

1 mnpcid Country name $100 A100 100 The identfier of the country

CSV/TXT: The name of the country.

Patient status


F2.0 30 A status setting indicating that thepatient record is not shown in the DataCapture.This status can be set by rule “anonymize patient” orin the AdminTool.[ 1 = 'not shown']


F2.0 30 A status setting indicating that thepatient record has been marked as being anonymized (no pseudonym). [ 1 = 'deleted Pseudonym']


F2.0 30 A status setting indicating that thepatient record has been frozen. This status can be set by rule 'freeze patient' or in the AdminTool.





th

Description

[ 1 = 'data frozen']


F2.0 30 A status setting indicating that thepatient has deceased. This statuscan be set by rule 'patient deceased' or in the AdminTool.[ 1 = 'deceased']


F2.0 30 A status setting indicating that thepatient data in this project is frozen and may not be changed. This status can be set by rule 'freeze casenode' or in the AdminTool.[ 1 = 'Project: data frozen]


F2.0 30 A status setting stating that no new visits may be added for this patient in this project. This status can be set by rule 'freeze following forms' or in the AdminTool.[ 1 = 'Project: closed visit plan']

3 mnpvisstartdate

Entry date DATE11 DATE11 10 Date of patient entry into the project. Base for the calculation ofthe patients visit plan.

r random Label of the randomization item

$100 A100 100 Randomization similar to the formtable with the randomizationbutton item. There may be

multiple columns of this type. Thecolumns includes either the

randomization number or therandomization group depending

on blinding of the project andchoosen export option. This

column(s) is(are) only exported ifthe configurable randomization is

used in the project.

r mnp_rdm_gr Label + "group" $100 A100 100 Randomization similar to the formtable with the randomization

button item. Depending on projectsetup there may be multiple

columns of this type. This columnis exported if the randomization isblinded, the unblinded option hasbeen selected for the export or a

patient has been unblindedpermanently due to an

emergency.

Form data

Scheme of column names for visit forms (example)v12_1_mnpxytable_mnpdocid Visit: listed by primary key, here with visitid = 21

Visit repetition: 1Table: mnptp0table ('mnp' + project scheme + user

entered value), for SAS format the tablesnames are replaced by a number to avoid too long column names. The





th

Description

replacement is documented in the formnumbers table.

Column: column name as defined per user (eCRF item)or meta data (see table descriptions)


Scheme of column names for casenode forms (example)

c_mnpxytable_mnpdocid Table: mnptp0table ('mnp' + project scheme + user entered value)Column: column name as defined per user (eCRF item)

or meta dataOptional for sub forms: ID of Repetitiongroup-question and number of

repetition

Scheme of column names for adverse event forms (example)

a1_3_mnpxytable_mnpdocid Adverse event number: counted by existance per patient, here = 1Repetition/Followup: counted by existance per patient, here = 3Table: mnptp0table ('mnp' + project scheme + user

entered value)Column: column name as defined per user (eCRF item)

or meta data


Scheme of column names for image forms (example)

i5_mnpxytable_mnpdocid Image form: repetition: 5Table: mnptp0table ('mnp' + project scheme + user

entered value)Column: column name as defined per user (eCRF item)

or meta dataOptional for sub forms: ID of Repetitiongroup-question and number of

repetition

The following columns are repeated for each form.

mnpdocid Document-ID 10 F10.0 10 Each eCRF document record hasa unique document identifier.

Document edit

2 mnplastedit Date of last edit DATETIME20 DATETIME23.2 18 Date when record was last edited (=saved).


F10.0 150 The identifier of the user who created the form. Investigators are exported as code lists and theidentifier is the key of the code list.

CSV/TXT: Full name of participant

2 mnppusid Patientuser-ID 10 F10.0 10 Patient ID if the patient has made the change instead of the participant, references the mnppid from the casenode table. If set this is the same ID as the current patient. This column is only exported if the project configuration includes the PSD function.

2 sigstatus Signature status $2 F2.0 2 Numerical description of the action leading to data storing.





th

Description

This flag is always set, independent of any necessary e-signature. Meaning of values:

[ 1 = data edited 2 = review A 3 = review B 4 = comment 5 = query asked 6 = query answered 7 = data freeze 8 = data unfreeze 9 = sdv (only with SDV) 10 = revoke review A 11 = query resolved 12 = data entry complete (only DEC) 13 = modify data (only DEC) 14 = manual freeze 15 = data import 16 = revoke entry complete(only DEC)

17 = Query withdrawn

19 = DDE entry 20 = DDE entry completed 21 = DDE entry reopened 22 = DDE comparison finished 23 = DDE entry corrected ]

24 = REVALIDATE

2 sigreason Reason for modification

$200 A200 200 Manually entered reason for modification of data after setting the "data entry complete" status. Required only for this action. Thiscolumn is only exported if the project configuration includes the DEC workflow.

2 0mnpvsno Version number 10 F10.0 10 Version number of project (will only be set in productive area).

2 mnpvslbl Version label $30 A30 30 Version label of project (will only be set in productive area).

Signature validation

4 siguser Signature user $200 A200 200 Textual representation of the user:

TNTITEL+TNVORNAME + TNNACHNAME (of table PARTICIPANT). Only for validation purposes.

4 sigtext Signature text $30 A30 30 This is the textual description of the action leading to data storing. It is the same signature text that the user was presented during the signature process.

4 sigvalid Signature validity $10 A10 10 Validity of signature. This is only exported if chosen by option.[ valid invalid not signed ]





th

Description

4 sigversion Signature algorithm version

2 F2.0 2 Numerical type of signature algorithm version.[0 = signature made before 3.1 1 = signature made since 3.1 2 = signature made since 4.0 ]

Structure

3vmnpcvpid Patient visit-ID 10 F10.0 10 Unique identifier for each patient visit.

3vmnpvisno Visit number 10 F10.0 10 Individual number of visit for the given casenode. This number is calculated during the creation of the visit, it does not necessarily reflect the temporal sequence of visits. Scheduled and unscheduled visits are counted independently. Unscheduled visits are counted separate for each type.

3vmnpvispdt Planned date of visit

DATE9 DATE11 10 The planned date of the visit. For a fixed visit this date is predefinedby the visit plan. For flexible, free and unscheduled visits this date is entered during the creation of anew visit by the participant.

3vmnpvisfdt Date of first data entry in visit

DATETIME20 DATETIME23.2 18 The date of first data entry. Normally this should be the real date of visit.

3amnpaeid Adverse Event-ID 10 F10.0 10 Unique identifier of an Adverse Event.

3amnpaedate Adverse Event date

DATETIME20 DATETIME23.2 18 The date when the Adverse Eventoccurred.

3amnpaeno Adverse Event casenumber

10 F10.0 10 Individual number of the Adverse Event for the given casenode. This number is calculated during the creation of an Adverse Event, it does not necessarily represent the temporal order of events.

3amnpaefuid Adverse Event Follow-up-ID

10 F10.0 10 The ID of a follow-up to the Adverse Event.

3amnpaefudt Adverse Event Follow-up date

DATETIME20 DATETIME23.2 18 The date when the patient data was collected for the follow-up.

3i mnpcrtdt Document create date

DATETIME20 DATETIME23.2 18 The date of the creation of this document.

3i mnpcrtpt Document creator (participant)

10

[cltn.]

F10.0 150 The user who creates this document. This information is not exported if investigator data are not to be exported. Investigators are exported as code lists and theidentifier is the key of the code list.

CSV/TXT: full name of participant.





th

Description

3i mnpcrtpusid Document creator (patientuser)

10 F10.0 10 The patientuser who creates this document. This is the current Patient ID if the patient has made the change instead of the participant. This column is only exported if the project configuration includes the PSD function.

Form status

7 mnpfs0 Form status (Review A)

2[clfs_0x.]

F2.0 30 A status stating that the record has been reviewed with review level 1.[ 1 = 'medical reviewed(A)']

7 mnpfs1 Form status (Review B)

2[clfs_1x.]

F2.0 30 A status stating that the record has been reviewed with review level 2.[ 1 = 'data reviewed(B)']

7 mnpfs2 Form status (Freeze)

2[clfs_2x.]

F2.0 30 A status stating that the record is manually frozen and data may no longer be altered.[ 1 = 'manually frozen']

7 mnpfs3 Form status (System-Freeze)

2 [clfs_3x.]

F2.0 30 A status stating that the record is frozen by system and data may no longer be altered.[ 1 = 'rule based frozen']

7 mnpfcs0 Form completion status

2[clfs_0x.]

F2.0 30 A status indicating that the completion status of a record.[ 0 = 'empty' 2 = 'partially completed' 4 = 'completed']

7 mnpfcs1 Validation status (error)

2[clfs_1x.]

F2.0 30 A status stating that validation errors are stored in the record. [ 1 = 'with error']

7 mnpfcs2 Validation status (warning)

2

[clfs_2x.]

F2.0 30 A status indicating that confirmation warnings are stored in the record.[ 1 = 'with warning']

7 mnpfcs3 Data entry complete status

2[clfs_3x.]

F2.0 30 A status indicating the data entry on this record is completed. Further changes are only possibleif queries are made. This status isonly exported, if the project configuration includes the DEC workflow.

7 mnpfsqa Form status Queries

2 [clfqa.]

F2.0 30 A status stating if any query or answered query is set on this record. If the status is set to 'Query' there is at least one open query on this record. If the status is set to 'Answer' than all existing queries on this record has been answered.[0 = '' 1 = 'with open query' 2 = 'with answered query' 4 = 'all queries





th

Description

resolved']

7 mnpfsct Form status Comments

2[clct.]

F2.0 30 A status stating if any comment has been made on this record.[1 = 'with comment']

7 mnpfssdv Form status SDV 2[clfssdv.]

F2.0 30 A status stating the progress of source data verification. This status is only exported if the project configuration includes the SDV function.[ 1 = 'not done' 2 = 'not necessary' 4 = 'not possible' 8 = 'deferred 16 = 'in progress' 32 = 'verified' 64 = 'verified with errors']

7 mnpfsdde Form status DDE 2[clfsdde.]

F2.0 30 A status describing the progress of the double data entry (DDE). This status is only exported if the project configuration includes the DDE function.[ 0 = 'DDE comparison finished' 1 = 'entry in progress' 2 = 'entry completed' 3 = 'ignore' (duplicate)]

5 mnphide Hidden in DataCapture

$2 F2.0 30 Status determines if the form washidden explicitly. This status is only exported if the project configuration includes any hiddenelement.

Form content data according project definition

According to the form definition the user defined items are listed for each form. Subforms are repeated as often as the maximal number for each export. The item repetitions are marked by appending repetition indizes.

NOTE: It is not possible to export form data of visit forms not shown in any visit with the rectangular export format!

6.25 formnumbers

This table is only exported for the rectangular SAS format. Here the form table names in the column namesare replaced by simple numbers in the sequence of occurrence in export. To map the numbers to the tablenames this information is given in a separate table.



formid Form-ID 10 F10.0 Identifier of the Form-Definition. This may not be the same ID as in the non-rectangularsetup definition.

formtablename DB table name $100 A100 Table name as given in the project setup definition.



7. CDISC ODM 1.3

7.1 Introduction

CDISC, the Clinical Database Interchange Standards Consortium, has developed several XML standards forthe interchange of clinical data. The Operational Data Model (ODM) represents data that can be transferredamong different systems during clinical trials or be used for archival storage. The format is vendor-independent and system-neutral. Study meta-data, study data and administrative data can be exported.

In the productive ExportSearchTool the audit trail will be exported with all existing MetaDataVersions of theexported project and corresponding ClinicalData elements.

7.2 ODM Data structure

ODM v1.3 has the following main sections:

Studyallows the representation of various studies in one file. It contains the protocol and form-setup definitions. The following sub-elements of "Study" are exported:

GlobalVariablescontains the study name.

MetaDataVersioncontains setup information regarding the study, including definitions of the visits, the eCRFs associated with each visit, the information collected on each eCRF, and code lists. For each project version as created by a project release a corresponding MetaDataVersion element is exported when the export option "with Audit Trail" has been selected.

AdminDataincludes administrative data such as references to the investigators and the trial centres. Also signature definitions are exported here.

ClinicalDatacontains the collected data items of the study. In the "ClinicalData" section, all study data is included. The data is represented according to the hierarchy for each subject (StudyEventData, FormData, ItemGroupData, ItemData), which in turn is equivalent to the meta-data hierarchy (StudyEvent, Form, ItemGroup, Item).

If the exported data include the audit trail then for each exported MetaDataVersion a corresponding ClinicalData element is exported if there has been any data changes in that setup version.

In CDISC and secuTrial® the wording for some elements are different. Both notations could be used in thefollowing description. Some of the elements are listed below:

secuTrial® CDISC

project study

patient subject

centre location

location address

Omitted information

The following sections are not included in the secuTrial® 5.1 ODM v1.3 export:

ReferenceDatagives information about the validity of data, such as value ranges not necessarily study-specific.

Associationfor annotations across different elements.

ds:Signaturefor signing the xml document itself. Do not mix up with the signature applied to an eCRF! The latter is documented with the "Signature" element.



Besides the matching problems mentioned below some setup information are omitted in the export. Theymay be included into future versions of secuTrial®.

setup information about non stored forms (as used for printing or display only)

rules and checks, including error messages

measurement units for number fields

Artifical study elements

There are some articifical study elements introduced by secuTrial® to allow the export of meta information,that are related to the eCRFs but not directly entered:

Study event random: RANDOM

The assigned random group or random number of a patient is exported as an additional study event witha single Form element, including a single ItemData element and one or two Item elements for eachrandomisation button, containing random number and or random group. The random button-itemsthemselves are additionally exported as normal eCRF item data. If unblinding during export has beenselected than only the data in the artifical random form is unblinded by providing both informations(number and group).

Form visit date: F.VMI

Because the visit date can be changed independent from any eCRF handling, a separate form for thisdate is used. The transactions of this form reflect the editing of the visit plan in the DataCapture.

ItemGroup subject identifier: FG.SUBJID

It was requested to include the patient pseudonym as an additional item into each eCRF form. So a newItemData and Item element has been created for this. As the pseudonyms cannot change, this item isonly inlcuded in the first INSERT transaction.

Normally the Pat-ID is used as the pseudonym. If this is not used in the project for patient identification orthe participant has no role right to see this, either the Add-ID or the Lab-ID is used, depending on projectand role configuration.

For centre forms the centre name is used as the subject identifier.

ItemGroup form status: FG.FS

The different form status are included in a separate form group on the beginning of each form. For everysingle status (see table description for mnp-tables above), an own Item element “FF.FS” is created.These elements are included into every transaction.

ItemGroup form saved timestamp: FG.MNP

The time stamp of eCRF editing is included as a separate ItemGroup element with a single Item“FF.MNPLASTEDIT” element. These elements are also included into every transaction.

Audit Trail

The secuTrial®-CDISC export is build as a single import file into other systems. In contrast to the other exportformats of secuTrial® the audit trail is not handled with separate files (or tables) but with subsequenttransactions to the same FormData element. The transaction type of the first statement is set to "Insert"whereas the subsequent entries to the same eCRF are set to "Update". The current data of the eCRF is thelast transaction.

In the productive ExportSearchTool all existing project versions are exported as separate MetaDataVersiondefinitions and corresponding ClinicalData elements. So every eCRF transaction is exported with the relatedMeta DataVersion element (=project version), with which the transaction was made.

If no audit trail is exported all transactions are of type "Insert".

Queries and Comments

Queries and comments are exported as annotations to the single item data. If the "typed data format" hasbeen chosen than the AnnotationID is given as an attribute of the ItemData<Type> element, the annotationitself will be listed in the Annotations element. With the "untyped data format" the Annotation will be includeddirectly as a sub element of the ItemData element.



If no audit trail is exported the complete list of queries and comments are added to the current data (=lasttransaction) with the transaction type set to "Insert" if the format of the data is untyped. In this case thecomplete list of queries and comments will therefore be exported (if the option is chosen) even if the audittrail is omitted. If the audit trail is included the particular query or comment entry is added to the correctparticular transaction. In this case the element UserEntry will not be added to the annotation (if iAS extensionhas been selected), because the user of the form data is responsible for the annotation too.

If the typed data format is chosen and the audit trail is omitted, than only those queries and comments will beexported that has been added as the last transaction to the data.

Hidden data

As it is not allowed to delete any collected (productive) data, in secuTrial® it is possible to hide single items,item groups(=questions) or forms from view in the DataCapture if this information shall not be collected anylonger. This data could be included into an export.

If the iAS extensions are used than hidden data are denoted by the attribute "ias:hidden" in the studydefinition of the FormData, ItemGroupData or ItemData elements. Without the iAS extension this data isflagged up by annotations added to the hidden data element (FormData, ItemGroupData or ItemData)

secuTrial® and CDISC

There are some limitations in matching the data within secuTrial® data with the CDISC format:

Signature, Queries/Comments and sequence of transactions

The action of making a query or comment to the data in secuTrial® could include the e-signature. Herethe complete data of the made annotation and the referenced eCRF data are signed. If the audit trail isomitted the annotation is not appended to the transaction statement where it was made, but allannotations are appended to the last (current) data but only if the untyped data format is chosen. Fortyped data export only a query or comment appended as a last transaction could be exported (seebelow).

So the e-signature is normally applied as a Signature element to a FormData element. If all queries areappended to the single transaction for a snapshot export then the additional UserEntry is added whenthe iAS extension has been chosen and the data is exported in the untyped data format.

To get a complete and exact impression of the query management we recommend using the typed dataexport with included audit trail.

Queries and Annotations

For queries a series of related annotations belong to one discussion. This fact is not reflected in theODM definition. In the iAS extension therefore the QueryID element has been declared to allow thegrouping of annotations by the same QueryID. This query ID is displayed in the user interface of thesecuTrial® DataCapture module. As the comment IDs are displayed also, a corresponding CommentIDelement has been declared for that type of annotation too.

If the standard ODM version is used, only the AnnotationID indicates the grouping of related annotationsby using the query ID as the first number part.

Transactions and AuditRecord

If the audit trail is exported, the type of the ODM file is "transactional" and for every FormData elementan AuditRecord element is given. It contains the "ReasonForChange" where the content of the "sigtext"and optional "modifyreason" column is exported. If the audit trail is not exported, no AuditRecord isgiven.

With multiple project setup versions and included audit trail multiple ClinicalData elements are exported.Then the SubjectData and StudyEventData elements are included in different ClinicalData elements forthe same patient and visit when the save of an eCRF has been done with different project versions.Therefore subsequent listings of such elements have applied "Update" transactions. But there could beno AuditRecords given as the elements are not changing themselves but the included elements arechanging.



LocationRef in AuditRecord

The AuditRecord element of each form has a mandatory location entry. During the process of saving aneCRF in secuTrial® the participant and time are stored for the action, but not the information aboutlocation. For the export the location of the patient is used here, as this should have been the locationduring editing. However, as it is possible for patients to change their location (=centre) via the AdminToolthis information may not represent the correct former centre.

Therefore this information is only added to the last transaction.

(Note: a location element in a web based application is as good as useless as a data entry could bemade from all over the world and do not necessarily reflect the physical location of the data entry point.)

Roles

In CDISC only three roles are defined without further information to the meaning of this definition. A rolecan only be given directly to a participant. In secuTrial® the role concept is quite sophisticated. The rolesare defined with dynamic rights concerning application functions. A participant can have different rolesdedicated to his participation in different centres (=locations). Therefore most times the role properties ofparticipants will be left empty for export. Only when participants are assigned directly to a project the roleproperty will be set. For matching this to the CDISC role specifications the role name in secuTrial® isliterally compared to the CDISC role names. If it does not match with any of these, the label "Other" isset.

Typed Item data and Annotations

As it is only allowed to add a single AnnotationID attribute to an ItemData<Type> element there aresome restrictions for this type of data format in the combination with other export options.

If the audit trail is omitted only a query or comment appended as a last transaction could be exported.

If hidden data are exported without iAS extension it could be possible that the AnnotationID for thehidden flag could not be added to a hidden ItemData<Type> element if the affected item has anotherannotation like a query, comment or sdv entry. For that case the more important information is added inthe hierarchy: query > comment > sdv > hidden.

Included data

Is it valid in the CDISC ODM definition to omit the part of the study definition or admin data as long as former ODM files are referenced in the PriorFileOID attribute of the ODM element where all administrative or study OID referenced in the current file are declared.

As it is not possible in the ExportSearchTool application design to guarantee that such a former file is available this option is not implemented in secuTrial® 5.1 to assure the generation of valid CDISC ODM files. The former selectable option of including administrative and or setup data has therefore been disabled.

Images

In contrast to all other items an uploaded image file contains more information than just a simple one-dimensional measurement. In CDISC ODM there is no option to include such multi-dimensional item data. Here we decided to export the (server-generated) filename as the most unique identifier for the image. If the iAS extension is chosen an additional ImageID allows to reference the separate information exported in the ImageData elements (following the principle of Annotations).

Date Formats

All date fields edited in the eCRFs (iAS date components) are stored as strings in the database following thepattern YYYYMMDDHHMISS.

YYYY is a four digit year value, e.g. 1956

MM is a month in number starting with 01 for January and 12 for December

DD is the day of the month

HH is the hour value of the time (in 24 hours-cycle)

MI is the minute value of the time

SS is the second's value of the time.

Other system-generated dates are stored in a real date format in the database.



CDISC formats for date and time are compliant with ISO 8601.

ODM demands the specification of the time zone. "Datetime" is the only format that is specified with a timezone value. ODM 1.2 defines: “A missing time zone specification means that the relationship between thelocal clock and Universal Time is not known.” In secuTrial® time zone is specified within the configuration file(default is CET / CEST).

Type iAS Format CDISC Format Description Example (typed data)

date DD-MM-YYYY date YYYY-MM-DD EffectiveDate="2004-08-23"

time-stamp

DD-MM-YYYY HH:MM:SS (Z)

datetime YYYY-MM-

DDThh:mm:ss.n+hh:mm

<DateTimeStamp>2004-05-19T18:05:44.000+02:00</DateTimeStamp>

iAS date compo-nents

YYYY partialDate YYYY <ItemDataPartialDate ItemOID="FF.birthdate_3">1974</ItemDataPartialDate>

MM-YYYY partialDate YYYY-MM <ItemDataPartialDate ItemOID="FF.birthdate_3">1974-09</ItemDataPartialDate>

DD-MM-YYYY partialDate YYYY-MM-DD <ItemDataPartialDate ItemOID="FF.pregdate_5">1998-05-05</ItemDataPartialDate>

DD-MM-YYYY HH:MM

partialDatetime YYYY-MM-DDThh:mm

<ItemDataPartialDatetime ItemOID="FF.pregdate_5">1998-05-05T10:09</ItemDataPartialDatetime>

HH:MM partialTime hh:mm <ItemDataPartialTime ItemOID="FF.birthdate_3">10:09</ItemDataPartialTime>

HH:MM:SS partialTime hh:mm:ss <ItemDataPartialTime ItemOID="FF.stopdate_7">20:17:32</ItemDataPartialTime>

MM:SS incompleteDatetime mm:ss <ItemDataIncompleteDatetime ItemOID="FF.startdate_7">------T-:17:32</ItemDataIncompleteDatetime>

iAS checked date compo-nents

YYYY partialDate YYYY <ItemDataPartialDate ItemOID="FF.birthdate_3">1974</ItemDataPartialDate>

MM-YYYY partialDate YYYY-MM <ItemDataPartialDate ItemOID="FF.birthdate_3">1974-09</ItemDataPartialDate>

DD-MM-YYYY date YYYY-MM-DD <ItemDataDate ItemOID="FF.pregdate_5">1998-05-05</ItemDataDate>

DD-MM-YYYY HH:MM

partialDateTime YYYY-MM-DDThh:mm

<ItemDataPartialDatetime ItemOID="FF.pregdate_5">1998-05-05T10:09</ItemDataPartialDatetime>

HH:MM partialTime hh:mm <ItemDataPartialTime ItemOID="FF.birthdate_3">10:09</ItemDataPartialTime>

HH:MM:SS time hh:mm:ss <ItemDataTime ItemOID="FF.stopdate_7">20:17:32</ItemDataTime>

MM:SS incompleteDatetime mm:ss <ItemDataIncompleteDatetime ItemOID="FF.startdate_7">------T-:17:32</ItemDataIncompleteDateTime>

iAS Y durationDatetime PnY <ItemDataDurationDatetime ItemOID="ff.scoredate">P54Y6M<



Type iAS Format CDISC Format Description Example (typed data)

date/timeintervals components

/ItemDataDurationDatetime>

Y-M PnYnM

Y-M-D PnYnMnD

Y-M-D-H-MH-M

PnYnMnDTnHnM

H-M-S M-S

PnYnMnDTnHnMnS

The partial date and time types are new introduced in ODM v1.3. As the complete date or time informationare only guaranteed in the secuTrial® checked date components with "YYYY-MM-DD" or "HH:MM:SS"format, all other components are declared partial with exception of the date component type "MM:SS".

The new calculated date/time intervals are exported as date durations. Be aware that they do not representexact time length!

As there is no time zone information in the iAS eCRF date components this part is not exported in eCRFdata.

7.3 secuTrial® Vendor Schema Extension

It is possible to extend the CDISC-export with vendor specific extensions. This is done in secuTrial ® with theschema definition in "ias.xsd". The namespace "ias" is defined as “http://www.secuTrial.de/cdisc/odm/v1.3”.This namespace is used to add secuTrial®-specific information to the export file. The schema describeselements and attributes for:

UserEntry (authorization for query and comments used in untyped data export without audit trail)

QueryID (id of queries)

CommentID (id of comments)

Validation of e-signature

Version of e-signature

Hidden data

SDV validation information

Images

This additional information can be chosen by selection the "include secuTrial® extensions" option for theCDISC-export format.

Since ODM v1.3 the standard xml definitions for namespaces and schemas are included with the files:

xml.xsd

xlink.xsd

xmldsig-core-schema.xsd

Since ODM v1.2.1 the schema description files are separated for the plain CDISC and vendor extension intoseparate files to allow more precise control over the sequence of elements. The two ODM files are:

ODM1-2-1-foundation.xsd

ODM1-2-1.xsd

The vendor extensions from secuTrial® are defined in three additional xsd files:

ias-ns.xsd

ias-extension.xsd

ias.xsd

In the iAS schema the following attributes and elements are redefined in ias-extension.xsd:

<?xml version="1.0" encoding="ISO-8859-1"?><xs:schema targetNamespace="http://www.cdisc.org/ns/odm/v1.3"



xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:ias="http://www.secuTrial.de/cdisc/odm/v1.3" elementFormDefault="qualified" attributeFormDefault="unqualified"> <xs:import namespace="http://www.secuTrial.de/cdisc/odm/v1.3" schemaLocation="ias-ns.xsd"/> <xs:redefine schemaLocation="ODM1-3-0.xsd">   <xs:group name="SubjectDataElementExtension"> <xs:sequence> <xs:element ref="ias:ImageData" minOccurs="0" maxOccurs="unbounded"/> </xs:sequence> </xs:group>  <xs:attributeGroup name="FormDefAttributeExtension"> <xs:attribute ref="ias:hidden"/> </xs:attributeGroup> <xs:attributeGroup name="ItemGroupDefAttributeExtension"> <xs:attribute ref="ias:hidden"/> </xs:attributeGroup> <xs:attributeGroup name="ItemDefAttributeExtension"> <xs:attribute ref="ias:hidden"/> </xs:attributeGroup>  <xs:attributeGroup name="FormDataAttributeExtension"> <xs:attribute ref="ias:sdv"/> </xs:attributeGroup> <xs:attributeGroup name="ItemDataAttributeExtension"> <xs:attribute ref="ias:sdv"/>

<xs:attribute ref="ias:ImageDataID"/> </xs:attributeGroup> <xs:attributeGroup name="ItemDataStarAttributeExtension"> <xs:attribute ref="ias:sdv"/>

<xs:attribute ref="ias:ImageDataID"/> </xs:attributeGroup>  <xs:group name="SignatureElementExtension"> <xs:sequence> <xs:element ref="ias:Validity" minOccurs="0" maxOccurs="unbounded"/>

<xs:element ref="ias:Version" minOccurs="0" maxOccurs="unbounded"/> </xs:sequence> </xs:group>  <xs:group name="AnnotationElementExtension"> <xs:sequence> <xs:element ref="ias:UserEntry" minOccurs="0" maxOccurs="unbounded"/> <xs:element ref="ias:QueryID" minOccurs="0" maxOccurs="unbounded"/> <xs:element ref="ias:CommentID" minOccurs="0" maxOccurs="unbounded"/> </xs:sequence> </xs:group> </xs:redefine></xs:schema>

with the basic definitions in ias-ns.xsd:

<?xml version="1.0" encoding="ISO-8859-1"?><xs:schema targetNamespace="http://www.secuTrial.de/cdisc/odm/v1.3" xmlns="http://www.w3.org/2001/XMLSchema" xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:odm="http://www.cdisc.org/ns/odm/v1.3" xmlns:ias="http://www.secuTrial.de/cdisc/odm/v1.3" elementFormDefault="qualified" attributeFormDefault="unqualified">

<xs:simpleType name="filecheck"> <xs:restriction base="xs:string"> <xs:enumeration value="valid"/> <xs:enumeration value="invalid"/> <xs:enumeration value="nonexistent"/> </xs:restriction> </xs:simpleType> <xs:simpleType name="filetype"> <xs:restriction base="xs:string"> <xs:enumeration value="original"/> <xs:enumeration value="web"/> <xs:enumeration value="thumbnail"/> </xs:restriction>



</xs:simpleType>

<xs:attribute name="sdv" type="xs:decimal"/> <xs:attribute name="hidden" type="xs:boolean"/> <xs:element name="Validity" type="xs:string"/> <xs:element name="Version" type="odm:integer"/> <xs:attribute name="ImageDataID" type="xs:IDREF"/  <xs:element name="UserEntry"> <xs:complexType> <xs:sequence> <xs:element ref="odm:UserRef"/> <xs:element ref="odm:DateTimeStamp"/> </xs:sequence> </xs:complexType> </xs:element> <xs:element name="QueryID"> <xs:complexType> <xs:attribute name="value" type="odm:integer"/> </xs:complexType> </xs:element> <xs:element name="CommentID"> <xs:complexType> <xs:attribute name="value" type="odm:integer"/> </xs:complexType> </xs:element>  <xs:element name="ImageFileData"> <xs:complexType> <xs:attribute name="type" type="ias:filetype"/> <xs:attribute name="filename" type="xs:string"/> <xs:attribute name="filestatus" type="ias:filecheck"/> </xs:complexType> </xs:element> <xs:element name="ImageData"> <xs:complexType> <xs:sequence> <xs:element ref="ias:UserEntry" minOccurs="0" maxOccurs="1"/> <xs:element ref="ias:ImageFileData" minOccurs="0" maxOccurs="3"/> </xs:sequence> <xs:attribute name="ID" type="xs:ID" use="required"/> <xs:attribute name="uploadedfilename" type="xs:string" use="required"/> <xs:attribute name="contenttype" type="xs:string"/> <xs:attribute name="imagesize" type="xs:integer"/> </xs:complexType> </xs:element></xs:schema>

7.4 Structure summary

The general structure of the elements in the xml is listed here without respect to optional or multiple elementsand attributes:

<?xml?><ODM>

<Study><GlobalVariables>

<StudyName></StudyName><StudyDescription/><ProtocolName></ProtocolName>

</GlobalVariables><BasicDefinitions/><MetaDataVersion>

<Protocol><StudyEventRef/>

</Protocol><StudyEventDef>

<FormRef/></StudyEventDef><FormDef>

<Description><TranslatedText></TranslatedText>

</Description><ItemGroupRef/>

</FormDef><ItemGroupDef>

<ItemRef/>



<Alias/></ItemGroupDef><ItemDef>

<Question><TranslatedText></TranslatedText>

</Question><CodeListRef/><Alias/>

</ItemDef><CodeListDef>

<CodeListItem><Decode>

<TranslatedText></TranslatedText></Decode>

</CodeListItem></CodeListDef>

</MetaDataVersion></Study><AdminData>

<User><LoginName></LoginName><FullName></FullName><FirstName></FirstName><LastName></LastName><Adress>

<StreetName></StreetName><City></City><StateProv></StateProv><PostalCode></PostalCode><OtherText></OtherText>

</Adress><Email></Email><Fax></Fax><Phone></Phone><LocationRef/>

</User><LocationDef>

<MetaDataVersionRef/></Location><SignatureDef>

<Meaning></Meaning><LegalReason></LegalReason>

</SignatureDef></AdminData><ClinicalData>

<SubjectData><InvestigatorRef/><SiteRef/><Annotation>

<Comment></Comment><Flag>

<FlagValue></FlagValue><FlagType></FlagType>

</Flag></Annotation><StudyEventData>

<FormData><AuditRecord>

<UserRef/><LocationRef/><DateTimeStamp></DateTimeStamp><ReasonForChange></ReasonForChange>

</AuditRecord><Signature>

<UserRef/><LocationRef/><SignatureRef/><DateTimeStamp></DateTimeStamp><ias:Validity></ias:Validity><ias:Version></ias:Version>

</Signature><Annotation>



</Flag></Annotation><ItemGroupData>



<ItemData><Annotation>



</Flag><ias:UserEntry>

<UserRef/><DateTimeStamp></DateTimeStamp>

</ias:UserEntry><ias:QueryID/><ias:CommentID/>

</Annotation></ItemData>

</ItemGroupData><ItemGroupData>

<ItemDataInteger></ItemDataInteger></ItemGroupData>

</FormData></StudyEventData><ias:ImageData>

<ias:UserEntry><UserRef/><DateTimeStamp></DateTimeStamp>

</ias:UserEntry><ias:ImageFileData/>

</ias:ImageData></SubjectData><Annotations>

<Annotation><Comment></Comment><Flag>


</Flag><ias:UserEntry>

<UserRef/><DateTimeStamp></DateTimeStamp>

</ias:UserEntry><ias:QueryID/><ias:CommentID/>

</Annotation></Annotations>

</ClinicalData></ODM>

The description explains the attributes and content most of the used CDISC elements. For each element theinterpretation of the element in the CDISC export in relation to secuTrial® is explained first. Then a shortexample is given whether there are any relevant attributes or body content, followed by a description ofspecific attributes. The secuTrial® extensions are classified by the namespace "ias:". Elements with nofurther information are omitted from this description.

The notation "LB:TEXT" means that the element "TEXT" is translated via the secuTrial® LanguageBundleinto the language of the secuTrial® installation. (Mostly the verbalization of the element "TEXT" is crudeEnglish, it is only used as a short wildcard.)

For further details concerning sequence of elements and whether they are optional or mandatory, pleaserefer to the CDISC ODM v1.3 documentation.

7.5 Element description: General information

<ODM>

The ODM element is the frame of the whole export. General information about schema and content are givenhere. The export file object is identified with the FileOID which is built in secuTrial® by the TAN. This is notnecessarily unique for each and every file, but should suffice in combination with the creation date todistinguish the files.

<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/cmldsig#" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ias="http://www.secuTrial.de/cdisc/odm/v1.3" xsi:schemaLocation="http://www.secuTrial.de/cdisc/odm/v1.3 ias.xsd" Description="Patients (All patients); User Data(yes); AuditTrail(yes); Queries and Comments(yes); Pseudonym(yes);



HiddenFields(yes); Esignature(yes); Validity(yes); SDV(yes);" FileType="Transactional" FileOID="secuTrial.de/ST26/IAS1/10_20080618-121059" CreationDateTime="2008-06-18T15:14:36.553+02:00" ODMVersion="1.3" Originator="interActive-Systems" SourceSystem="secuTrial" SourceSystemVersion="5.1">

xmlns:ias secuTrial® namespace if the secuTrial® format extensions have been chosen.

xsi:schemaLocation reference and file for the secuTrial® vendor format extension.

Description textual compendium of selected export options

FileType ["Transactional"| "Snapshot"] fixed value, if the audit trail is included the type is"Transactional".

FileOID ["secuTrial.de/" + customer.dbprefix + "/" + customerschema.modelname + "/" +project.versionNumber + "_" + timestamp] unique identifier of export file build fromthe domain name of secuTrial®, the customer db-prefix, the project schema, theproject version number and the timestamp of export

CreationDateTime timestamp of the generation of the file.

ODMVersion ["1.3"] the secuTrial® version 5.1 implements the ODM version 1.3. To tellprocessing systems that the xsd schema is used in exchange for the dtd, this hasto be added.

Originator [customer.customername] Customer name owning the project.

SourceSystem ["secuTrial"]

SourceSystemVersion version as specified in the sources and configuration file. This is displayed in thebrowser title of each secuTrial®-application.

7.6 Element description: Project setup

<Study>

The Study element describes the setup and administrative data of a study. For multiple studies severalStudy elements could be contained in one file. In secuTrial® only single projects (=studies) can be exported.Only study elements used for collecting data are exported. Plain informative objects like display forms orheadlines are not exported.

<Study OID="IAS1">

OID [customerschema.modelname] The model name (=DB-scheme) name of the project.The model name always uniquely identifies a study within a secuTrial® installation.

<StudyName>

The body contains the name for the study as defined in the FormBuilder.

<StudyName>Teilprojekt</StudyName>

<StudyDescription>

This is a mandatory element, but as there is no complement in secuTrial® this field is left blank.

<ProtocolName>

This is a mandatory element, but as there is no exact complement in secuTrial® this field is set to the modelname of the exported project, too.

<ProtocolName>IAS1</ProtocolName>

<MetaDataVersion>

This is the current setup description for export. This is matched with the project version information asdefined in the FormBuilder. Most of the information derives from the visit plan and the defined forms.



The whole export of the setup defines both a reference element and a definition for that reference. Thereforethe hierarchy is quite flat in contrast to the export of the study data itself.

In the productive area for every archive and current project version a MetaDataVersion element is exported.In the setup area only the development version itself is given here.

<MetaDataVersion OID="IAS1.1" Name="Basisregister (1.0)">

OID [customerschema.modelname + "." + project.versionNo] The identification is builtfrom the model name and the version number of the project.

Name [project.formattedName] This is the label of the project combined from the projectname and the version label. In this form the project name is displayed in theDataCapture status information. (For development project from the setup-test areathe version label displays the last project save-time. For productive projects thelabel has been entered by the participant during the release.)

<Protocol>

This is close to the visit plan defined in the FormBuilder. Furthermore forms for capturing adverse event andpatient status information are defined here, too. These are only added, if forms of the type "AdverseEvent"and "Casenode" are actually defined as form families. So the protocol includes all stored form presentationoptions of the secuTrial® patient matrix.

<StudyEventRef>

This is the reference for an event as described above.

<StudyEventRef StudyEventOID="VISIT.619" OrderNumber="1" Mandatory="Yes"/><StudyEventRef StudyEventOID="AE" Mandatory="No"/><StudyEventRef StudyEventOID="CN.15" Mandatory="No"/><StudyEventRef StudyEventOID="RANDOM" Mandatory="No"/><StudyEventRef StudyEventOID="CTR.32" Mandatory="No"/>

StudyEventOID ["VISIT." + visit.visitid | "AE" | "CN." + formfamily.fyid | "CTR." +formfamily.fyid | "RANDOM"] The identification of a study event is a token for thekind of event (normal visit, adverse event or patient status information (= casenodefamilies / "CN"). As several visits can be defined in the visit plan of the project, it ismost likely that there are multiple visit-events. They are distinguished by theprimary key of the secuTrial® visit-object added. Patient status events aredistinguished by the corresponding formfamily ID. If a project does not declare formfamilies for casenode or adverse event level, the appropriate study events areomitted. The RANDOM event is an addition for the export of the configurablerandomization. Existing centre-form families will be exported as separate studyevents with the prefix "CTR".

OrderNumber [ i+1 ] The sequence of presentation the visits to the user, starting with 1. Eventsfor status forms or adverse events have no ordering.

Mandatory [ "Yes" | "No" ] The scheduled visits which are created for the initial visit planbelong to the normal study progress and are therefore mandatory. AEs do notnecessarily occur; neither must CN events contain forms that have to be filled.Unscheduled visits are not mandatory too.

<StudyEventDef>

This is the actual definition of a study event. Each reference has a separate definition.

<StudyEventDef OID="VISIT.619" Name="1. Visite" Repeating="Yes" Type="Scheduled" Category="fest"><StudyEventDef OID="AE" Name="Adverse Event" Repeating="Yes" Type="Common"><StudyEventDef OID="CN.15" Name="Patientstatus" Repeating="No" Type="Unscheduled"><StudyEventDef OID="RANDOM" Name="randomization" Repeating="No" Type="Unscheduled"><StudyEventDef OID="CTR.32" Name="Centre information" Repeating="No" Type="Unscheduled">

OID reference to StudyEventOID as defined in the StudyEventRef

Name [visit.visitLabel | project.casenodeFamily.ffamilyname |project.aeFamily.ffamilyname | project.centreFamily.ffamilyname |

"randomization"] name indication type of event as in description above; for adverseevents and casenode, the name of the respective form families are used. For visits



the visit label as displayed in the matrix is given. If there is no label defined, thedefault from the language bundle is used.

Repeating [ "Yes" | "No" ] Adverse events are repeating elements where the number ofoccurrence is undefined; visits can differ here: if the visit plan as defined in theFormBuilder has no maximum number of visits or the number of defined visits isless than the maximum number of visits then the last defined visit is also repeating,same for unscheduled visits; CN events are never repeating.

Type [ "Scheduled" | "Unscheduled" | "Common" ] Visits are scheduled or unscheduled(as defined in FB); adverse events are common; patient status forms are exportedas "CN" events are defined as unscheduled (the type for AE and CN eventschanged from last secuTrial® version!).

Category [ visit.visittypeLabel ] The type of the visit is given here. This attribute is onlygiven for visits.

<FormRef>

Each stored form of a project setup which is no subform is referenced for a study event. All visit forms arereferenced in their corresponding visit.

ATTENTION: If a form for the type "Visit" is not referenced - any longer - in any visit and the audit trail isomitted, it will not be exported neither as definition nor the (possibly previous entered) formdata.

In the CDISC ODM data model the study events does not represent any additional information besides thepresented forms. Especially the visit plan date could not be matched here. Instead of the former attributeextension secuTrial® 5.1 now exports an artificial form "F.VMI" (= visit meta information) with only the subjectidentifier and visit plan date as included items. The visit plan date is marked with the SDSVarName"VISITDY" according the CDISC SDTM data model. The possible history of the visit plan is exported ascorresponding transactions to this form.

Additionaly the randomisation is exported as an artifical form “F.RANDOM” that is included in theunscheduled CN StudyEvent element. This randomisation form is included for any randomisation.

Image forms will be referenced in each StudyEventDef element because the relation between such a form isnot predefined in the setup and will be set during the first completion of the form.

<FormRef FormOID="F.mnptp4sonstiges" OrderNumber="1" Mandatory="No"/>

FormOID [ "F.VMI" | 'F.RANDOM' | "F." + form.formtablename ] DB table name of the formas defined in the FormBuilder. The artificial visit information form has the OID"F.VMI" (=visit meta information), the artifical random form has the OID"F.RANDOM".

OrderNumber [ repetitionIndex +1 ] This is the sequence of display in the visit. This number isderived from the sorting of the forms in the visit (or adverse event or casenode). Ifthere are non-stored forms in the visit, this number may be discontinuously. Imageforms will have no number as their presentation is not sorted.

Mandatory [ "No" ] It is not possible in secuTrial® to force the user to fill in a form; hence thisattribute is always set to no.

<FormDef>

<FormDef OID="F.mnptp4untersuchung" Name="Untersuchung" Repeating="No" ias:hidden="true"><FormDef OID="F.mnptp4ae" Name="Adverse Event" Repeating="Yes">

OID reference to FormOID as defined in FormRef

Name [ form.formname ] form display name as in the patient matrix

Repeating [ "Yes" | "No" ] For adverse events this property is set to "Yes" because the formsare filled in for each follow-up. Also Image forms will have this property set to"Yes". All other forms have this value set to "No".

ias:hidden [ "true" ] If a form has been hidden from the data collection but is included in theexport (option "include hidden fields" and with the iAS extension) then this attributeis added to the form definition.



ias:ddetype [ "normal form" | “DDE form” ] If the DDE function is used, single forms can bemarked as used for double data entry.

<Description>

This element could be included into a FormDef, ItemGroupDef or ItemDef element. At the moment this isused in secuTrial® only for the FormDef element.

<Description><TranslatedText xml:lang="de">Bitte füllen Sie alle Felder nach genauer Befragung aus.</TranslatedText>

</Description>

xml:lang [ "de" | "en" ] language as defined for the project (either directly in the projectdesign, by the customer design or the application default. At the moment secuTrial®

allows either a German or English installation. The form description is onlyavailable as entered in the FormBuilder; most times this will be similar to theproject language version.

text [ form.formdescr ] informative text to be displayed beneath the form title.

<ItemGroupRef>

The form hierarchy in secuTrial® works with an intermediate question between the DB-table as defined in aform and the DB-column as referenced in the item. CDISC ODM uses a similar construction. For eachquestion an item group is defined. The sequence of item groups represents the sequence in the form.

Additionally secuTrial® defines the document status information of each form. This information is exported asan additional item group as CDISC ODM does not provide an appropriate element at form level.

CDISC recommends exporting the patient identifier as a separate item for monitoring errors and changes.Because it is not possible to add items directly to patients, an artificial item group and item is added to eachand every form to export this value. This item group is only exported for the first transaction. If neither thepseudonym nor the aid is selected for an individual export, this first item group is completely omitted.

The single item in this group contains the patient identification information as selected for export. Thisinformation is marked as the SDSVarName "SUBJID" which references the external CDISC SubmissionMetadata Model (SMM). If both identifiers (pseudonym and aid) are selected, this field contains thepseudonym.

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.VISITDY" Mandatory="Yes"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.MNP" Mandatory="Yes"/><ItemGroupRef ItemGroupOID="FG.RANDOM" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.1268" OrderNumber="10" Mandatory="No"/>

ItemGroupOID [ "FG.SUBJID" | "FG.VISITDY" | "FG.FS" | "FG.MNP" | "FG.RANDOM" | "FG." +formgroup.fgid ] The first item group in every form contains the patient pseudonymwith the OID "FG.SUBJID", the second the form status information; this item grouphas the OID "FG.FS". The artifical item group “FG.MNP” contains the last savedate of the form data. The item group for the visit plan date has the OID"FG.VISITDY". The item group for the random form has the OID "FG.RANDOM".For each other item group the prefix "FG." is used followed by the primary key ofthe secuTrial® question DB representation object form group.

OrderNumber [ i + 1 ] The sequence of appearance on the form; this does not necessarilyrepresent the exact position (as headlines are not exported at all); the additionalitem groups "FG.FS", "FG.VISITDY" and "FG.SUBJID" has no number as thesegroups are not presented to the user but are only internally managed by thesystem.

Mandatory [ "Yes" | "No" ] It is not possible in secuTrial® to force the user to fill in a question;hence this attribute is normally set to "No". Only the visit day item group is set to"Yes" because this internal field is always given for each existing visit.

<ItemGroupDef>

<ItemGroupDef OID="FG.SUBJID" Name="patient identifier" Repeating="No" IsReferenceData="No">



<ItemGroupDef OID="FG.VISITDY" Name="Geplantes Visitendatum" Repeating="No"><ItemGroupDef OID="FG.FS" Name="document status information" Repeating="No" IsReferenceData="No"><ItemGroupDef OID="FG.MNP" Name="saved" Repeating="No" IsReferenceData="No"><ItemGroupDef OID="FG.RANDOM" Name="randomization" Repeating="No"><ItemGroupDef OID="FG.1268" Name="Geburtsdatum" Repeating="No" IsReferenceData="No"

ias:hidden="true" Domain=”DM”><ItemGroupDef OID="FG.1275" Name="Bisherige Behandlung" Repeating="Yes" IsReferenceData="No">

OID Reference to the ItemGroupOID as defined in the ItemGroupRef

Name [ "patient identifier" | "document status information" |"saved" |

"randomization" | formgroup.fgquerylabel ] The first item group represents thepatient identifier, the second the form status information and is labelledappropriately, the next item group consists of a single item with the save date ofthe form; for a normal item group the unique label (for search) of the question isused.

Repeating [ "Yes" | "No" ] For repetition groups this property is set to "Yes"; all other questiontypes are set to "No"; in the data exported for this group for each repetition anItemGroupData element is exported with a corresponding repeat key.

isReferenceData [ "No" ] This is always set to "No" as secuTrial® does not include references toexternal data.

ias:hidden [ "true" ] If an item group has been hidden from the data collection but is includedin the export (option "include hidden fields" and with the iAS extension) then thisattribute is added to the item group definition.

Domain [ formgroup.sdtmdomain ] references the CDISC Submission Metadata Model(SDTM). For content see CDISC definitions. If an SDTM domain has been given forthe item group definition it is exported as an additional attribute. For greaterflexibility this domain can be entered in freetext in the project setup definition.Therefore it cannot be garantueed that the exported doamin is a real valid SDTMdomain.

<ItemRef>

The DB columns are represented as items both in CDISC ODM 1.2.1 and in secuTrial®. The sequence ofitems within an item group is the same as within the form. The items of subforms are directly included in theouter repetition group.

<ItemRef ItemOID="FF.SUBJID" Mandatory="No"/><ItemRef ItemOID="FF.VISITDY" Mandatory="Yes"/><ItemRef ItemOID="FF.FS.0" Mandatory="No"/><ItemRef ItemOID="FF.MNPLASTEDIT" Mandatory="Yes"/><ItemRef ItemOID="FF.RANDOM.random1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.1921.d1" OrderNumber="1" Mandatory="No"/>

ItemOID [ fixed text | "FF." + formfield.formgroup.fgid + "." + formfield.ffcolname ]The items in the additional form status item group as fixed id-names (see below);for normal form fields the id is built with the prefix "FF.", the form group id and theDB column name of the item. Item OIDs of the artifical elements:

FF.SUBJID patient identifierFF.VISITDY visit plan dateFF.FCS.0 completion status (code list)FF.FCS.1 validation status errorFF.FCS.2 validation status warningFF.FCS.3 data entry complete (only if DEC is used in the project)FF.FS.0 review A status FF.FS.1 review B status FF.FS.2 freeze statusFF.FS.3 system-freeze statusFF.FQA query status of document (code list)FF.FCT comment status of documentFF.FSDV sdv status of document (only if SDV is used in the project)FF.MNPLASTEDIT timestamp for last edit of documentFF.RANDOM.random1 column name of the randomization item in the artifical

random form ("random1" is an example)



OrderNumber [ i + 1 ] Sequence and position of items in an item group; the additional items todefine the form status have no number set as they are not displayed to the user butare only internally calculated by the system.

Mandatory [ "Yes" | "No" ] Normally items are set to "No". Only if there is a "mandatory" ruledefined for this item this attribute is set to "Yes". Conditional mandatory fields arenot marked this way.

<Alias>

The alias element can be used to supply an additional meaning to the parent element. For example it can beused for more complex SDMT annotations. It is allowed in the ItemGroupDef and the ItemDef elements.

<Alias Context="SDTM" Name="Domain: DM Demographics"/>

Context [ odmalias.context ] freetext describing the interpretation context of the aliasname.

Name [ odamailas.name ] freetext describing the other name and meaning of the parentelement.

<ItemDef>

The item definition describes the kind of data collected in this column. Further information about interpretingthe data (like references to a code list) and the question presented on the form are given. In secuTrial ® thequestion for an item could be stored either on the item or on the item group (=question) level. Hence theexport in the CDISC-question element combines both possible texts. Consequently, the translated text mightbe the same as the name of the surrounding item group.

<ItemDef OID="FF.SUBJID" Name="Patientidentifikation" DataType="string" Length="20" SDSVarName="SUBJID"/>

<ItemDef OID="FF.VISITDY" Name="Geplantes Visitendatum" DataType="date" SDSVarName="VISITDY"/><ItemDef OID="FF.FS.0" Name="Medizinischer Review (A)" DataType="integer" Length="2"/><ItemDef OID="FF.RANDOM.random1" Name="random1" DataType="string" Length="100"/><ItemDef OID="FF.1921.d1" Name="d1" DataType="date" SDSVarName="BRTHDTC"><ItemDef OID="FF.1925.epcc2d" Name="epcc2d" DataType="string" Length="5" ias:hidden="true">

OID Reference to the ItemOID as defined in the ItemRef.

Name Either fixed name for the status from the LanguageBundle or the column name ofthe normal item (formfield.ffcolname).

DataType [ "integer" | "float" | "date" | "partialDate" | "time" | "partialTime" |"partialDatetime" | "incompleteDatetime" | "string" ] For text fields, text areasand randomization items the DataType is set to "text"; for scores, unit group-number fields and number fields with fractal portion the DataType is set to "float";for simple number fields and all fields with reference values such as checkboxes,radio buttons or lookup tables the DataType is set to "integer". For secuTrial® datecomponents the data type depends on the displayed are normally partial orincomplete date, time or datetime types. Only for checked date (dd.mm.yyyy) andchecked time (hh:mi:ss) components real date and time data types could be used.

Length [ formfield.fieldLength | formfield.fieldtype.ffA + formfield.fieldtype.ffB |2*formfield.fieldLength ] For text items the length-value equals the number ofcharacters displayed in Unicode; due to the xml-format of the file some Unicodecharacters might need more than one printing character to be represented; for floatitems the length and significant digits are needed; the length is calculated from thenumber of digits before and after the decimal point.

SignificantDigits [ formfield.fieldtype.ffB ] Number of digits after the decimal point; this one isrequired only for float items.

SDSVarName [ "SUBJID" | "VISITDY" | formfield.sdsvarname ] references the CDISCSubmission Metadata Model (SDTM). For content see CDISC definitions. At themoment the first two special variables are constantly used in secuTrial® for theitems "FF.SUBJID" and "FF.VISITDY". For normal items the additionalSDSVarName defined for the item is exported. For greater flexibility this variablecan be entered in freetext in the project setup definition. Therefore it cannot begarantueed that the exported variable is a real valid SDTM variable.



ias:hidden [ "true" ] If an item has been hidden from the data collection but is included in theexport (option "include hidden fields" and with the iAS extension) then this attributeis added to the item definition.

ias:ddecomp [ "compare" | "ignore completly" | "ignore case and whitespace" (only text) |"compare including hash values" (only images) ] If the DDE function is used, forthe form each text and image item can configured how to be handled during DDEcomparison.

<CodeListRef>

<CodeListRef CodeListOID="CL.clfcs_0"><CodeListRef CodeListOID="CL.1921.rb2"/><CodeListRef CodeListOID="CL.lmnpias2tier"/>

CodeListOID [ "CL." + fixedText | "CL." + formfield.formgroup.fgid + formfield.ffcolname| "CL." + formfield.lookuptablename ] The id of a code list begins with the fixedprefix "CL." followed either by a fixed text for general code lists like form completionstatus or subject status; for radio buttons or popup fields the code list id is builtfrom the form group primary key and column name of the respective item; forlookup fields the lookup table name is used. Therefore multi-referenced lookuptables are exported only once as a code list.

<CodeList>

Code lists are exported to interpret normal form item fields as well as standard status fields and annotationtypes.

<CodeList DataType="integer" OID="CL.clfcs_0" Name="Ausfüllstatus"><CodeList DataType="integer" OID="CL.1921.rb2" Name="rb2"><CodeList DataType="integer" OID="CL.lmnpias2tier" Name="Haustiere">

DataType [ "integer" | "text" ] Code lists normally consist of integer values as codes.

OID Reference to the definition in CodeListRef.

Name [ fixed text | formfield.ffcolname | formfield.lookupdescription.

lddescription ] The name of a code list depends on its type; for standard code liststhis is a fixed text as translated by the LanguageBundle. For code lists for normalform fields the DB-column name is used; for code lists of lookup tables this is thedescription stored in the corresponding lookup-description object.

<CodeListItem>

The code list item is the representation of a single value and decoded value (=text) of a code list. Thedecode element displays the textual representation of the code.

<CodeListItem CodedValue="1" Rank="1><Decode>

<TranslatedText xml:lang="de">männlich</TranslatedText></Decode>

</CodeListItem>

CodedValue [ fixed value | fvalue.fvvalue | lmnptable.mnplid ] fixed value for status flag,stored database value for this option or primary key of lookup table entry.

Rank [ i + 1 ] sequence of presentation.

<TranslatedText>

The translated text is used to display the question on a form or the code of a code list.

<TranslatedText xml:lang="de">männlich</TranslatedText><TranslatedText xml:lang="en">empty</TranslatedText>

xml:lang [ "de" | "en" ] language as defined for the project (either directly in the projectdesign, by the customer design or the application default. At the moment secuTrial®

allows either a German or English installation, the standard code lists and items(form status) could be given in both languages; the questions of the items or thecode lists built of lookup tables or for normal form field items are only available as



entered in the FormBuilder; most times this will be similar to the installed languageversion.

text [ LB: status value | lmnptable.mnpname | fvalue.fvlabel ] LanguageBundle labelfor status flag, displayed text of option or lookup entry.

7.7 Element description: Participant administration

The user specific data is exported in a “user” element. The role of a user is exported as attribute “UserType”.The ODM differs between four roles: UserType (Sponsor | Investigator | Lab | Other); if the user has a rolethat is not equal to ‘Sponsor’, ‘Investigator’ or ‘Lab’, the default role ‘Other’ is set. Due to the role architecturein secuTrial®, the role "Other" is likely to be used in most cases.

If a user is member in more than one location, the locations are exported as multiple references. A role isonly exported if the user has one role directly associated with the project or the user participates in exactlyone centre. In the first case all centres of this project are referenced as locations for this user.

The locations include all centres of the exported project, regardless if any participant or subject is included.

<AdminData>

The user, location and signature definitions are included into this element which no further attributes given.

<User>

A user element is the description of information connected with a user. Most parts can be omitted if the fieldsare empty. There might be two addresses, one for the private and one for the working postal address of auser. The second one is distinguished by the clinic name in the "OtherText" element. Either one or both maybe omitted.

<User OID="USER.262" UserType="Other"><User OID="USER.1">

<LoginName>susanne</LoginName><FullName>Dipl. biol. Susanne Schneider</FullName><FirstName>Susanne</FirstName><LastName>Schneider</LastName><Address>

<StreetName>Dieffenbachstr. 33c</StreetName><City>Berlin</City><StateProv>Deutschland</StateProv><PostalCode>10967</PostalCode>

</Address><Address>

<StreetName>An der Spree 1</StreetName><City>Berlin</City><StateProv>Deutschland</StateProv><PostalCode>12345</PostalCode><OtherText>Charite</OtherText>

</Address><Email>[email protected]</Email><Fax>00 54321</Fax><Phone>00 12345</Phone><LocationRef LocationOID="LOCATION.263"/>

</User>

OID [ "USER." + participant.ptnid ] Fixed prefix followed by the primary key of the DBobject participant.

UserType [ participant.role.rolename | "Other" ] Only set if the participant has a roledirectly associated with the project; the role name is used if it matches textually thedefinition with one of the CDISC types; otherwise the type "Other" is set.

LoginName [ participant.login ] This is the unique login name the participants use to accessthe secuTrial® system.

FullName [ participant.fullName ] This is built from the participant title, first name andsurname.

FirstName [ participant.tnvorname ]

LastName [ participant.tnnachname ]

StreetName [ participant.tnstrasse | participant.location.strasse +

participant.location.hausnummer ] The first is the private address which is only



given at all when this attribute is set; the second attribute is used for the workingaddress; in secuTrial® the "location" is just the postal address, whereas the CDISC"location" is represented by the secuTrial® "centre" name! Only given if set.

City [ participant.tnort | participant.location.stadt ] only given if set.

StateProv [ participant.country.cname | participant.location.country.cname ] only given ifset.

PostalCode [ participant.tnplz | participant.location.plz ] only given if set.

OtherText [ participant.location.klinikname ] If this parameter is set the address is theworking address of the participant; it should represent the name of the clinic ormedical office.

<LocationRef>

<LocationRef LocationOID="LOCATION.263"/>

LocationOID [ "LOCATION." + centre.ctrid ] fixed prefix followed by the primary key of the DBcentre object.

<Location>

The reference to the MetaDataVersion states that the location is not generally valid but belongs to a versionof the system. However, in secuTrial® only the name of locations (=centres) could change. Once createdneither the id could be changed nor can the location be deleted.

<Location OID="LOCATION.364" Name="Hannover" LocationType="Site"><MetaDataVersionRef StudyOID="IAS2" MetaDataVersionOID="IAS2.2" EffectiveDate="2008-06-18"/>

</Location>

Name [ centre.agname ] The name of the centre as defined in the AdminTool; withinsecuTrial® all centre names have to be unique even across several projects (atleast within one customer area of an installation).

LocationType [ "Site" ] All centres in secuTrial® could technically be used for collecting data, soall are declared as "sites".

MetaDataVersionRef reference to the last, current project version as described in the last exportedMetaDataVersion element. The effective date is the date of the file generation.

<SignatureDef>

The Signature tag may be contained in a FormData element, ItemData element, ItemGroupData element,StudyEventData element, or SubjectData element. In secuTrial® CDISC exports signatures are only appliedto FormData elements. The signature will only be exported, if the option “E-Signature and validation” hasbeen selected.

An electronic signature applies to a collection of clinical data and indicates that a specific user accepts legalresponsibility for this data (see 21 CFR Part 11). The signature identifies the person signing, the location ofsigning, the signature meaning (via the referenced SignatureDef), the date and time of signing, and anencrypted hash value of the included data.

An electronic signature applies to the entity to which it is attached (in this case an electronic case reportform). The signature covers all clinical data in that entity at the time of signing, including all clinical data inany sub-entities. Thus, a signature on a form includes all clinical data at the form, item group, and itemlevels.

The feature for signing in secuTrial® is called "e-signature". It can be configured via the FormBuilder forwhich action a signature is required (saving data, reviewing a form, commenting data, freezing, etc.).

<SignatureDef OID="SIG.0" Methodology="Electronic"><Meaning>Daten eingegeben</Meaning><LegalReason>Daten eingegeben</LegalReason>

</SignatureDef>

OID [ "SIG." + i ] The signature definitions are built from all used signatures in the DB.After the fixed prefix "SIG" an index of collection is used. (So the OID could differfrom export to export.)



Methodology [ "Electronic" ] Of the two possibilities for computer signatures (electronic ordigital) in secuTrial® only the electronic signature is implemented.

Meaning [ DocumentStore.decodeSigstatus(document.sigstatus) ] Textual representation ofthe action; the "sigstatus" is an integer representing every possible action resultingin form storing; the decoding is done during the export, whereas the LegalReasonwas decoded during the action and stored textually in the DB. The exported texthere could change if the LanguageBundle or the used language has beenchanged.

LegalReason [ document.sigtext ] Stored text for action; this text was presented to the userduring the sign action; the same decoding is used as for the getting of "Meaning".This text is unchangeable.

7.8 Element description: Clinical data

<ClinicalData>

The collected data of the study is exported in this part. The study name and meta data version under whichthe export is performed is referenced here (this is not necessarily the version under which the data wascollected).

In secuTrial® the project version no and version label are stored in the form data, at least when they are set.So it could be referenced for every form data with which project version the data has been collected. InCDISC there is no appropriate reference for this. So the reference to the correct "MetaDataVersionOID" isexported as a form annotation if given.

<ClinicalData StudyOID="IAS2" MetaDataVersionOID="IAS2.1"><ClinicalData StudyOID="IAS2" MetaDataVersionOID="IAS2.2">

<SubjectData>

As the form data of a single subject could be edited in different study meta data versions, the single patientcould be listed more than once. Therefore a transaction type is added to this element. Because the elementitself is not edited but only the included form data elements there is no direct audit record element attachedhere.

<SubjectData SubjectKey="SUBJECT.345" TransactionType="Insert"><InvestigatorRef UserOID="USER.343"/>

<SubjectData SubjectKey="SUBJECT.345" TransactionType="Update"><SiteRef LocationOID="LOCATION.364"/>

SubjectKey [ "SUBJECT." + patient.pid | "SUBJECT.CTRID" + centre.ctrid ] After the prefixthe primary key of the DB patient object is used. For centre-forms the centres areexported as subjects too, in this case the primary key of the centre with the prefix"CTR." is used as the subject ID. This is unique across all studies and does notrepresent any identification information as presented to the user; henceanonymised patients or exports without the pseudonym or additional id are stillvalid. As data for the same subject could be edited in different study version apatient could be included in different clinical data elements. In that case thesubsequence listings have the transaction type set to "Update".

LocationRef Reference to the participant who entered the patient into the current project (eitherby creating a new patient in a registry or by adding the patient into a part-project.This reference is only given in the first (Insert) transaction.

SiteRef Reference to the centre the patient is dedicated. This reference is only given in thelast transaction.

<Annotation> - Subject

For each patient, the information about his/her status (SeqNum=1) and the information about his/her statuswithin the project (SeqNum=2) are always exported. If the export of the pseudonym (SeqNum=3) andadditional id (SeqNum=4) are also included depends on the export options. If these fields are not filled in, anempty annotation is exported. The type and value of these annotations are decoded by the specified, fixedcode lists.



These subject annotations are only added to the last transaction representing the current subject status. Theannotations for the subject status (1 and 2) are only exported, if the option meta data option “Patient status”has been selected..

<Annotation SeqNum="1"><Comment>active</Comment><Flag>

<FlagValue CodeListOID="CODELIST.SubjectStatus">0</FlagValue><FlagType CodeListOID="CODELIST.SubjectType">0</FlagType>

</Flag></Annotation>

Comment [ patient.getCumulatedPatientStatusString(patient.patientenstatus) ] Textualrepresentation of the whole patient status as given in the AdminTool.

<Annotation SeqNum="2"><Comment>active</Comment><Flag>

<FlagValue CodeListOID="CODELIST.SubjectStatus">0</FlagValue><FlagType CodeListOID="CODELIST.SubjectType">1</FlagType>

</Flag></Annotation>

Comment [ patient.getCumulatedPatientStatusString(casenode.cnstatus) ] Textual re-presentation of the casenode status as given in the AdminTool under projectstatus.

<Annotation SeqNum="3"><Comment>iwx616</Comment><Flag>

<FlagValue CodeListOID="CODELIST.SubjectIdentifier">0</FlagValue></Flag>

</Annotation>

Comment [ patient.pseudonym ] This is what is named "patient PID" in the secuTrial®

references; it is used to reidentify patients within all the different secuTrial®

applications; this field is exported according to the selected export options; if theproject configuration claims to hide this field, it can not be selected for export; inthis case the annotation is omitted.

<Annotation SeqNum="4"><Comment/><Flag>

<FlagValue CodeListOID="CODELIST.SubjectIdentifier">1</FlagValue></Flag>

</Annotation>

Comment [ patient.aid ] Additional id for patients; it can be empty depending on the projectconfiguration; if this field is not used in the project at all, it is not possible to beselected for export and this annotation will be omitted.

<StudyEventData>

Visits, adverse events and the patient status matrix are handled as study events. Therefore, each visit, eachadverse event and the patient status matrix are exported as single study events. The number or visit eventsdepend on the visit plan of each patient.

As the form data of a single study event could be edited in different study meta data versions, the singleevent could be listed more than once. Therefore a transaction type is added to this element. Because theelement itself is not edited but only the included form data elements there is no direct audit record elementattached here.

<StudyEventData StudyEventOID="VISIT.625" TransactionType="Insert"><StudyEventData StudyEventOID="VISIT.625" TransactionType="Update"><StudyEventData StudyEventOID="AE" StudyEventRepeatKey="AE.1.1" TransactionType="Insert"><StudyEventData StudyEventOID="CN" TransactionType="Insert"><StudyEventData StudyEventOID="CTR" TransactionType="Insert"><StudyEventData StudyEventOID="RANDOM" TransactionType="Insert">



StudyEventRepeatKey [ casevisitplan.visitno + "." + (i+1) | "AE." + adverseevent.aeno + "." +(i+1) ] If the visit is defined as repeating, the stored visitno is exported; this numberis set during the creation of each individual visit regardless if this is a repeating visitor not; therefore it is possible that it does not start with "1"; for adverse events theaeno is used which is calculated during the creation of the individual adverseevent; if adverse events may be created independent from the temporal sequence,the order of time and repeat key may differ. Therefore additional the repetitionindex is appended, similar to the building of a visit. This should guarantee uniquerepeat keys even for merged patients.

<FormData>

The audit trail of eCRFs is exported as a sequence of transactions to the same form data element. The firstelement has the transaction type set to "Insert", every following element is set to "Update". Every childelement will inherit the transaction type. Only if a new item group or item element is declared in a subsequentmeta data version element, the transaction type of an internal element could differ from the outer type. Eachtransaction is listed in the clinical data element for the corresponding meta data version with which the formwas saved (in former secuTrial® version indicated by an annotation).

The form is the basic element for collecting data in secuTrial®. For this reason the AuditRecord andSignature element are only appended to this ODM element.

To export additional information from secuTrial® to CDISC annotations are used. The first annotation(SeqNum=1) displays the document-ID. One annotation (SeqNum=2) provides the action for storage; this isthe same information as in the SignatureElement. As not necessarily all forms or actions have to be signed,the reason for saving is backed up here, too.

The last annotation (SeqNum=4) is exported if the option for checking the signature validity is selected (onlyavailable if the e-signature is configured in the project).

<FormData FormOID="F.mnpias2komponenten" TransactionType="Insert"><FormData FormOID="F.mnpias2komponenten" TransactionType="Update"><FormData FormOID="F.mnpias2ae" FormRepeatKey="AE.1.1.FU.1" TransactionType="Insert">

FormRepeatKey ["AE." + adverseevent.aeno + "." + (i+1) + ".FU."+ (j+1) ] If the form belongsto an adverse event, then it is declared as repeating. In this case the ae event keywith the follow-up repetition index is used as the repeat key.

<AuditRecord>

<AuditRecord><UserRef UserOID="USER.384"/><LocationRef LocationOID="LOCATION.364"/><DateTimeStamp>2008-06-18T15:03:46.000+02:00</DateTimeStamp><ReasonForChange>Query eingefügt</ReasonForChange><SourceID>mnpdid.2.mnpatdid.3</SourceID>

</AuditRecord>

DateTimeStamp [ document.mnpdate in ISO-format ] timestamp of storage, same content as inSignature.DateTimeStamp (see below).

ReasonForChange [ document.sigtext + ": " + document.modifyreason ] reason for storage asdefined by action. This is stored textually in the field sigtext. If the action requiressigning, this text is presented to the user as legal reason (similar to signatureelement). For the action of data modification after the status "data entry complete"has been set (extended workflow) the participant has to supply a reason forchanging data. If this reason is set it is appended after the general text.

SourceID [ "mnpdid." + mnpdid | "mnpdid." + mnpdid + ".mnpatdid." + mnpatdid ] primarykey of the tpxdocument and the attpxdocument for transactions from the audit trail.

<Signature>

<Signature><UserRef UserOID="USER.343"/><LocationRef LocationOID="LOCATION.364"/><SignatureRef SignatureOID="SIG.0"/><DateTimeStamp>2008-06-18T15:19:28.000+02:00</DateTimeStamp><ias:Validity>gültig</ias:Validity>



<ias:Version>0</ias:Version></Signature>

ias:Validity ["valid" | "invalid" ] As it is possible that only some actions require an e-signature the "not signed" is an allowed state but then the Signature element is notappended at all. The validation is done during export by new calculation of thehash value across the stored data and comparison with the stored hash value.

ias:Version ["0" | "1" | "2" ] Displays the algorithm version with which the signature hasbeen generated.

<Annotation>

<Annotation SeqNum="1"><Comment>Dokument-Nr. 2 - 1</Comment>

</Annotation>

Comment [" Dokument-Nr. " + document.mnpdid + " - " + position in audit trail ]Document-ID as presented in the DataCapture; the included mnpdid is the primarykey of the document object in the DB.

<Annotation SeqNum="2"><Comment>Daten eingegeben</Comment><Flag>

<FlagValue CodeListOID="CL.sig">1</FlagValue></Flag>

</Annotation>

Comment [ DocumentStore.decodeSigstatus(document.sigstatus) ] Textual representation ofthe value of the Flag. (Could slightly differ to AuditRecord.ReasonForChange if theLanguageBundle has been updated during data collection. The meaning shouldnevertheless be similar.)

<Annotation SeqNum="4"><Comment>unsigniert</Comment><Flag>

<FlagValue CodeListOID="CL.sigvalid">0</FlagValue></Flag>

</Annotation>

Comment [ "not signed" | "valid" | "invalid" ] Status of the signature check: if the formhas not been signed, the first option is used and the signature is not checked;otherwise a "valid" flag indicates that a recalculation of the signature hash valueproduces the same result as the stored hash value and therefore the signature isvalid.

<Annotation SeqNum="5"><Comment>ausgeblendet</Comment><Flag>

<FlagValue CodeListOID="CL.clhd">1</FlagValue></Flag>

</Annotation>

Comment [ !form.isVisible ] Status of the 'hidden'-property: if set to "1" the form is hiddenfrom view in the DataCapture for data collecting and display. This annotation isonly exported if at least one element of the project-setup is set to 'hidden', theseelements shall be included in the export, the untyped data format is chosen and theexport does not use the secuTrial® extensions (see above). For more limitation seechapter: Hidden data.

<Annotation SeqNum="6"><Comment>DDE original document: 5281</Comment>

</Annotation>

Comment [ tpxdocument.dderealdid | tpxdocument.ddeduplicatedid ] Document-ID of theeither the real document (if this is the duplicate) or of the duplicate (if this is the realdocument) of the Double Data Entry. Which type of relation-id is used is describedby the label. Only exported if this is a DDE form.



<ItemGroupData>

The item group is an organization component for data. In secuTrial® this is matched to the form group level ofthe form setup.

Repetition groups with multiple subforms can be exported with a repeat key indicating the position of thesubform in the repetition. For these repetition groups the form group level of the contained subforms areignored an all contained subform-items are exported as items in this repetition group.

<ItemGroupData ItemGroupOID="FG.1923"><ItemGroupData ItemGroupOID="FG.1915" ItemGroupRepeatKey="0">

ItemGroupRepeatKey [ repetitionindex ] Position in the repetition of a subform.

<Annotation>

<Annotation SeqNum="1"><Comment>hidden</Comment><Flag>

<FlagValue CodeListOID="CODELIST.clhd">1</FlagValue></Flag>

</Annotation>

Comment [ !formgroup.isVisible ] If the form group is direct (property "hide") or indirect (byform) hidden from view in the DataCapture for data collecting and display. Thisannotation is only exported if at least one element of the project-setup is set to'hidden' and these elements shall be included in the export and the export does notuse the secuTrial® extensions (see above). For more limitation see chapter: Hiddendata.

<ItemDataTyped>

<ItemDataString ItemOID="FF.SUBJID">ukb615</ItemDataString><ItemDataInteger ItemOID="FF.FS.0">0</ItemDataInteger><ItemDataDatetime ItemOID="FF.MNPLASTEDIT">2004-05-19T18:05:44.000+02:00</ItemDataDatetime><ItemDataDate ItemOID="FF.1921.d1">2008-02-01</ItemDataDate><ItemDataPartialTime ItemOID="FF.1921.d2">14:30</ItemDataPartialTime><ItemDataInteger ItemOID="FF.1921.rb2">1</ItemDataInteger><ItemDataAny ItemOID="FF.1921.s1" IsNull="Yes"/><ItemDataDate ItemOID="FF.1921.d1" AnnotationID="Q.1.1">2008-02-01</ItemDataDate>

IsNull [ "Yes" ] If no value is stored (the DB column contains "null") this attribute is set;these two attributes are mutually exclusive. If this attribute is set than the type"ItemDataAny" is used.

ias:sdv [ sdvstatus-bit ] Status of the SDV for this item. This attribute is only exported ifthe project uses SDV and the export includes the secuTrial® extension.

ias:ImageDataID [ reference to the ImageData element ] The reference to the ImageDataElementwhich describes the image file(s) in more detail.

text [ patient.pseudnoym | formstatus-bit | mnplasteditdate |

valueOf(mnprecord.valueForKey (formfield.ffcolname) ] In this element the storedvalue for a column is given; for simple number fields or text this is the exact DBvalue; if the item definition references to a code list, this code list is used to decodethe exported value; if no value is stored (the DB column contains "null") thisattribute is not set.

For the additional items for the form status any value other than "null" implies thatthe status described in this item is set; checkbox values are recoded during export;in secuTrial® the non-checked box is stored as "null"; as this is a reasonable valueit is exported as "0". (If it is crucial to distinguish whether the user has explicitlychosen to answer "no" or if he/she hasn't answered at all, another item type suchas radio buttons should be used.)

All values are checked against the definition supplied in the item definition; if acode list value is missing or the format does not match, the CDISC file is not valid.

<ItemData>

<ItemData ItemOID="FF.1921.d1" Value="20080201"></ItemData>



<ItemData ItemOID="FF.1921.d2" Value="1430 "></ItemData><ItemData ItemOID="FF.1921.rb2" Value="1"></ItemData><ItemData ItemOID="FF.1921.s1" IsNull="Yes"></ItemData>

Value [ formstatus-bit | timestamp | valueOf

(mnprecord.valueForKey(formfield.ffcolname) ] In this element the stored value fora column is given; for simple number fields or text this is the exact DB value; if theitem definition references to a code list, this code list is used to decode theexported value; if no value is stored (the DB column contains "null") this attribute isnot set.

For the additional items for the form status any value other than "null" implies thatthe status described in this item is set; checkbox values are recoded during export;in secuTrial® the non-checked box is stored as "null"; as this is a reasonable valueit is exported as "0". (If it is crucial to distinguish whether the user has explicitlychosen to answer "no" or if he/she hasn't answered at all, another item type suchas radio buttons should be used.)

All values are checked against the definition supplied in the item definition; if acode list value is missing or the format does not match, the CDISC file is not valid.

IsNull [ "Yes" ] If no value is stored (the DB column contains "null") this attribute is set;these two attributes are mutually exclusive.

ias:sdv [ sdvstatus-bit ] Status of the SDV for this item. This attribute is only exported ifthe project uses SDV and the export includes the secuTrial® extension.

ias:ImageDataID [ reference to the ImageData element ] The reference to the ImageDataElementwhich describes the image file(s) in more detail.

<ImageData>

<ias:ImageData ID="mnpimgid.79" uploadedfilename="DSC_0189.jpg" contenttype="image/jpeg" imagesize="71130">

ID [ "mnpimgid." + tpximage.mnpimgid ] The unique identifier for this image, build withthe primary key of the database object.

uploadedfilename [ tpximage.uploadedfilename ] The plain (without path) filename from the upload(=client filename).

contenttype [ tpximage.contenttype ] The content specification as given from the browserduring upload (=mime type). This could be used as a hint to specify the applicationfor file handling.

imagesize [ tpximage.imagesize ] The file size of the uploaded image measured in bytes.

<ImageFileData>

<ias:ImageFileData type="original" filename="patientimages/5/75/75/1218213324296-192.168.101.144-7777-0.jpg" filestatus="valid"/>

type [ "original" | "web" | "thumbnail" ] The type of the described file, this couldeither be the uploaded "original", the displayed "web" image on the eCRF or theminimized "thumbnail".

filename [ tpximage.originalFullPathExport | txpimage.webFullPathExport |

tpximage.thumbnailFullPathExport ] The name and path to the exported image file.This is even set if the image does not exist. All images are exported in a separate"patientimages" folder. Inside this folder the images are evenly distributed intosubfolders according patient id parts.

filestatus [ "valid" | "invalid" | "nonexistent" ] Status if the named file exists (is includedinto export), is valid (=unchanged since upload) or invalid (changed since upload).For original file a nonexistent file has to be treated as an error since the uploadedfile has to exist. Because even non-image files can be uploaded in secuTrial®

nonexistent web- and thumbnail images are no error.

<Annotation>

Queries and comments are exported as annotations to the item data. In the comment the text entered by theuser is given, whereas the flag value distinguishes between query and comment. The flag type for queries



defines the type of query entry. The transaction type of these annotations is always set to "Insert" regardlessof the transaction type of the enclosing item, item group or form.

When queries and comments are cumulatively appended to the last form transaction (when no audit trail isexported this is only possible for untyped data, see chapter: Queries and Comments), they do notcorrespond to the AuditRecord entry of the enclosing form. To distinguish this information the secuTrial ®

extension for "ias:UserEntry" gives information about the user who made the annotation and the timestampof this action. If the audit trail is exported too the element "ias:UserEntry" is omitted for the query- andcomments annotation because the user of the current form data transaction is responsible for the annotationtoo.

The "ias:QueryID" is the query ID as displayed in the DataCapture. It allows subsuming several query-entriesto a single query (including the query, its answers, and finally the closing comment). Similar the comment IDis given in the "ias:CommentID" element.

The attribute SeqNum only reflects the sequence of listing and has no further meaning.

<Annotation SeqNum="0"><Comment>ausgeblendet</Comment><Flag>

<FlagValue CodeListOID="CL.clhd">1</FlagValue></Flag>

</Annotation>

Comment [ !formfield.isVisible ] If set to "1" the form field is hidden from view in theDataCapture for data collecting and display. This annotation is only exported if atleast one element of the project-setup is set to 'hidden' and these elements shall beincluded in the export and the export does not use the secuTrial® extensions. Formore limitation see chapter: "Hidden data".

<Annotation SeqNum="1"><Comment>Source Data Verification</Comment><Flag>

<FlagValue CodeListOID="CL.clfssdv">2</FlagValue></Flag>

</Annotation>

Comment [ sdvstatus for formfield in this mnprecord ] Status for the SDV of this item. Isonly exported if SDV is configured for the project and the export does not use thesecuTrial® extension (see above).

<Annotation SeqNum="2" TransactionType="Insert" ID="Q.1.1"><Comment>war das nicht eher noch einen Tag später?</Comment><Flag>

<FlagValue CodeListOID="CL.qact">1</FlagValue><FlagType CodeListOID="CL.clqa">1</FlagType>

</Flag><ias:QueryID value="1"/>

</Annotation>

ID [ "Q." + qaccontent.query.queryid + "." + qaccontent.qacid ] the ID is build witha fix prefix and the primary key of the query and the query entry. This ID is onlygiven in the typed data export where the item data annotations are exported in theseparate element and referenced in the item data by this ID.

Comment [ qaccontent.qactext ] The free text entry of the user.

ias:QueryID [ qaccontent.query.queryid ] the query ID as displayed in the DataCapture. By thisID the annotations which belong together could be identified. If the iAS extension isnot used, the grouping of annotations is only indicated by the first number part ofthe annotation ID.

<Annotation SeqNum="1" TransactionType="Insert" ID="C.1.2"><Comment>Operationsbericht stehen noch aus</Comment><Flag>

<FlagValue CodeListOID="CL.qact">0</FlagValue></Flag><ias:CommentID value="1"/>

</Annotation>



ID [ "C" + qaccontent.comment.commentid + "." + qaccontent.qacid ] the ID is buildwith a fix prefix and the primary key of the comment and the comment entry. ThisID is only given in the typed data export where the item data annotations areexported in the separate element and referenced in the item date element by thisID.

Comment [ qaccontent.qactext ] The free text entry of the user.

ias:CommentID [ qaccontent.comment.commentid ] the comment ID as displayed in the DataCap-ture. Only give with chosen iAS extension.

<Annotations>

If the typed data format is chosen than the annotations to single item data elements could not be added assub elements. Instead the AnnotationID is added as an item data attribute and all referenced annotations arelisted separate in an Annotations element parallel to the subject data elements.

As a side effect this typed data export limits the number of annotations possibly made to a single item datatransaction (see chapter: "Queries and Comments" and "Hidden data"). So with adverse export options someannotations needed for complete overview of query management or status information may not be includedin the CDISC export.



8. Appendix A-1: SAS program example/* File created on 04.09.2008 (CEST) by User: susanne *//* Data from Project Basisregister*//* Only Data from Centre 'Berlin' contained in export*/

DATA visitplan_ias1 (LABEL='Project visit plan');infile 'dat/visitplan_IAS1_20080904-174021.dat' missover LRECL=114;input mnpvisid 1-10 visitnumber 12-15 visittype 17-18 previsid 20-29 visitday 31-40 minusoffset 42-51 plusoffset 53-62 visitlabel $ 64-113;ATTRIB mnpvisid LABEL='Visit-ID' visitnumber LABEL='Visit sequence' visittype LABEL='Type of visit' FORMAT=clvt. previsid LABEL='Preceding visit-ID' visitday LABEL='Time lag to preceding visit (days)' minusoffset LABEL='Possible negative time frame (days)' plusoffset LABEL='Possible positive time frame (days)' visitlabel LABEL='Visit label';;run;/* == end of visitplan_ias1 == */

DATA visitplanforms_ias1 (LABEL='Forms in visit plan');infile 'dat/visitplanforms_IAS1_20080904-174021.dat' missover LRECL=22;input mnpvisid 1-10 formid 12-21;ATTRIB mnpvisid LABEL='Visit-ID' formid LABEL='Form-ID';;run;/* == end of visitplanforms_ias1 == */

DATA forms_ias1 (label='Form');infile 'dat/forms_IAS1_20080904-174021.dat' missover LRECL=352;input formid 1-10 formtablename $ 12-35 hidden 37-38 formname $ 40-239 formfamily $ 241-340 sequence 342-351;ATTRIB formid LABEL='Form-ID' formtablename LABEL='DB table name' hidden LABEL='hidden in DataCapture' FORMAT=clhd. formname LABEL='Form name (as in matrix)' formfamily LABEL='Form family name' sequence LABEL='Form sequence in form family';;run;/* == end of forms_ias1 == */

DATA questions_ias1 (label='Questions');infile 'dat/questions_IAS1_20080904-174021.dat' missover LRECL=237;input fgid 1-10 formid 12-21 sequence 23-32 hidden 34-35 fglabel $ 37-236;ATTRIB fgid LABEL='Question-ID' formid LABEL='Form-ID' sequence LABEL='Question sequence in form' hidden LABEL='hidden in DataCapture' FORMAT=clhd. fglabel LABEL='Question label (or unique label for search)';;



run;/* == end of questions_ias1 == */

DATA items_ias1 (label='Items');infile 'dat/items_IAS1_20080904-174021.dat' missover LRECL=1603;input ffid 1-10 fgid 12-21 sequence 23-32 ffcolname $ 34-65 hidden 67-68 fflabel $ 70-1569 lookuptable $ 1571-1600;ATTRIB ffid LABEL='Item-ID' fgid LABEL='Question-ID' sequence LABEL='Item sequence in question' ffcolname LABEL='DB column name' hidden LABEL='hidden in DataCapture' FORMAT=clhd. fflabel LABEL='Item label (or question label or unique label for search)' lookuptable LABEL='Name of lookup table';;run;/* == end of items_ias1 == */

DATA centres_ias1 (label='Centres');infile 'dat/centres_IAS1_20080904-174021.dat' missover LRECL=313;input mnpctrid 1-10 mnpctrname $ 12-111 mnpcname $ 113-312;ATTRIB mnpctrid LABEL='Centre-ID' mnpctrname LABEL='Centre name' mnpcname LABEL='Country name';;run ;/* == end of centres_ias1 == */

DATA casenodes_ias1 (label='Patient information');infile 'dat/casenodes_IAS1_20080904-174021.dat' missover LRECL=88;input mnppid 1-10 mnppsd $ 12-31 mnpptnid 33-42 mnpctrid 44-53 mnpcs0 55-56 mnpcs1 58-59 mnpcs2 61-62 mnpcs3 64-65 mnpcs4 67-68 mnpcs5 70-71 mnpcs6 73-74 mnpcs7 76-77 @79 visitstartdate;ATTRIB mnppid LABEL='Patient-ID' mnppsd LABEL='Patient pseudonym' mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpctrid LABEL='Centre-ID' mnpcs0 LABEL='Case status 0' FORMAT=clcs_0x. mnpcs1 LABEL='Case status 1' FORMAT=clcs_1x. mnpcs2 LABEL='Case status 2' FORMAT=clcs_2x. mnpcs3 LABEL='Case status 3' FORMAT=clcs_3x. mnpcs4 LABEL='Case status 4' FORMAT=clcs_4x. mnpcs5 LABEL='Case status 5' FORMAT=clcs_5x. mnpcs6 LABEL='Case status 6' FORMAT=clcs_6x. mnpcs7 LABEL='Case status 7' FORMAT=clcs_7x. visitstartdate LABEL='Entry date' INFORMAT=DATE9. FORMAT=DATE9.;;run;/* == end of casenodes_ias1 == */

DATA atcasenodes_ias1 (label='Patient information history');infile 'dat/atcasenodes_IAS1_20080904-174021.dat' missover LRECL=262;input mnppid 1-10



@12 oldvisitstartdate @22 newvisitstartdate mnpptnid 32-41 @43 changedate changereason $ 62-261;ATTRIB mnppid LABEL='Patient-ID' oldvisitstartdate LABEL='Old entry date' INFORMAT=DATE9. FORMAT=DATE9. newvisitstartdate LABEL='New entry date' INFORMAT=DATE9. FORMAT=DATE9. mnpptnid LABEL='Participant-ID' FORMAT=cltn. changedate LABEL='Date of change' INFORMAT=DATETIME18. FORMAT=DATETIME20. changereason LABEL='Reason for change';;run;/* == end of atcasenodes_ias1 == */

DATA atcasevisitplans_ias1 (label='Patient visit plan history');infile 'dat/atcasevisitplans_IAS1_20080904-174021.dat' missover LRECL=317;input mnppid 1-10 mnpcvpid 12-21 @23 oldmnpvispdt @33 newmnpvispdt oldmnpvisid 43-52 newmnpvisid 54-63 oldmnpvisno 65-74 newmnpvisno 76-85 mnpptnid 87-96 @98 changedate changereason $ 117-316;ATTRIB mnppid LABEL='Patient-ID' mnpcvpid LABEL='Patient visit-ID' oldmnpvispdt LABEL='Old planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. newmnpvispdt LABEL='New planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. oldmnpvisid LABEL='Old visit-ID' newmnpvisid LABEL='New visit-ID' oldmnpvisno LABEL='Old patient-visit number' newmnpvisno LABEL='New patient-visit number' mnpptnid LABEL='Participant-ID' FORMAT=cltn. changedate LABEL='Date of change' INFORMAT=DATETIME18. FORMAT=DATETIME20. changereason LABEL='Reason for change';;run;/* == end of atcasevisitplans_ias1 == */

DATA queries_ias1 (label='Queries');infile 'dat/queries_IAS1_20080904-174021.dat' missover LRECL=1117;input mnppid 1-10 mnpdocid 12-21 ffid 23-32 ffcolname $ 34-65 @67 qacdate mnpqueryid 86-95 querytype $ 97-97 querystatus 99-100 qacstatus 102-103 mnpptnid 105-114 qaccontent $ 116-1115;ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' qacdate LABEL='Date of entry' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpqueryid LABEL='Query-ID' querytype LABEL='Query type (manual or automatic)' querystatus LABEL='Query status (calculated status)' FORMAT=clqa. qacstatus LABEL='QAC status (type of query-entry)' FORMAT=clqa. mnpptnid LABEL='Participant-ID' FORMAT=cltn. qaccontent LABEL='Content';;run;/* == end of queries_ias1 == */



DATA comments_ias1 (label='Comments');infile 'dat/comments_IAS1_20080904-174021.dat' missover LRECL=1108;input mnppid 1-10 mnpdocid 12-21 ffid 23-32 ffcolname $ 34-65 @67 qacdate mnpcommentid 86-95 mnpptnid 97-106 qaccontent $ 108-1107;ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' qacdate LABEL='Date of entry' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcommentid LABEL='Comment-ID' mnpptnid LABEL='Participant-ID' FORMAT=cltn. qaccontent LABEL='Content';;run;/* == end of comments_ias1 == */

DATA sdv_ias1 (label='Source Data Verification');infile 'dat/sdv_IAS1_20080904-174021.dat' missover LRECL=100;input mnppid 1-10 mnpdocid 12-21 ffid 23-32 ffcolname $ 34-65 @67 sdvdate mnpfssdv 86-87 mnpptnid 89-98;ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' sdvdate LABEL='Date of entry' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfssdv LABEL='Status SDV' FORMAT=clfssdv. mnpptnid LABEL='Participant-ID' FORMAT=cltn.;;run;

/* == end of sdv_ias1 == */

DATA atsdv_ias1 (label='Audit Trail Source Data Verification');infile 'dat/atsdv_IAS1_20080904-174021.dat' missover LRECL=100;input mnppid 1-10 mnpatdocid 12-21 ffid 23-32 ffcolname $ 34-65 @67 sdvdate mnpfssdv 86-87 mnpptnid 89-98;ATTRIB mnppid LABEL='Patient-ID' mnpatdocid LABEL='ATDocument-ID' ffid LABEL='Item-ID' ffcolname LABEL='DB column name' sdvdate LABEL='Date of entry' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfssdv LABEL='Status SDV' FORMAT=clfssdv. mnpptnid LABEL='Participant-ID' FORMAT=cltn.;;run;

/* == end of atsdv_ias1 == */

DATA mnpias1komponenten (label='Basisdaten');infile 'dat/mnpias1komponenten_IAS1_20080904-174021.dat' missover LRECL=1448;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84



@86 mnpvispdt @96 mnpvisfdt mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131 mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 eppc1 $ 595-714 epcc2a $ 716-835 epcc2b $ 837-844 epcc2c $ 846-850 epcc2d $ 852-856 tier1 858-867 rasse1 869-878 farbe1 880-889 tier2 891-900 rasse2 902-911 farbe2 913-922 tier3 924-933 rasse3 935-944 farbe3 946-955 hb1 957-959 hb2 961-963 hb3 965-967 hb4 969-971 hb5 973-975 hb6 977-979 r1s1 981-983 r1s2 985-987 r1s3 989-991 r2s1 993-995 r2s2 997-999 r2s3 1001-1003 cb1 1005-1007 rb1 1009-1011 rrb1 1013-1015 cb3 1017-1019 rrb3 1021-1023 ugcb1 1025-1027 ug 1029-1050 ugm 1052-1054 ugt1 $ 1056-1059 ugcb2 1061-1063 ugt2 $ 1065-1068 ug1 1070-1091 ugm1 1093-1095 cb2 1097-1099 rb2 1101-1103 rrb2 1105-1107 pp1 1109-1111 score1 1113-1122 gz1 1124-1126 kz1 1128-1137 score2 1139-1148 text1 $ 1150-1189 text2 $ 1191-1310 zeit1 $ 1312-1317 datum1 $ 1319-1326 zeit2 $ 1328-1331 datum2 $ 1333-1338 ddd $ 1340-1347 random1 $ 1349-1353 hobbies1 1355-1364 haustier1 1366-1375 abcdefghijabcdefghij 1377-1379 cb4 1381-1383 rb3 1385-1387 rrb4 1389-1391 pp2 1393-1395



score3 1397-1406 farbe 1408-1410 hb7 1412-1414 hb9 1416-1418 hb8 1420-1422 bild1 1424-1433 bild2 1435-1444;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kh. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fs. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cf. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_t. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lv. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_iy. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kx. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_jf. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_jq. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fr. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_cp. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_bj. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ugt2 LABEL='Meßzeitpunkt - HHMI' ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_le. cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ip. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_kz. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_y. pp1 LABEL='Popup - CODELIST' FORMAT=cl_lg. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number'



score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' ddd LABEL='IASStandardGroup Zeitfelder - YYYYMMDD' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a. abcdefghijabcdefghij LABEL='Namenstest mit Regel - CODELIST' FORMAT=clcb. cb4 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cs. rb3 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_dg. rrb4 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_id. pp2 LABEL='Popup - CODELIST' FORMAT=cl_ff. score3 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bh. hb7 LABEL='Erste Reihe - CODELIST' FORMAT=cl_mh. hb9 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fm. hb8 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bq. bild1 LABEL='Lieblingsbild' bild2 LABEL='und noch ein Bild';;run ;/* == end of mnpias1komponenten == */

DATA atmnpias1komponenten (label='Basisdaten (Audit-Records)');infile 'dat/atmnpias1komponenten_IAS1_20080904-174021.dat' missover LRECL=1459;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 eppc1 $ 606-725 epcc2a $ 727-846 epcc2b $ 848-855 epcc2c $ 857-861 epcc2d $ 863-867 tier1 869-878 rasse1 880-889 farbe1 891-900 tier2 902-911 rasse2 913-922 farbe2 924-933 tier3 935-944 rasse3 946-955 farbe3 957-966 hb1 968-970 hb2 972-974 hb3 976-978 hb4 980-982 hb5 984-986 hb6 988-990 r1s1 992-994 r1s2 996-998 r1s3 1000-1002



r2s1 1004-1006 r2s2 1008-1010 r2s3 1012-1014 cb1 1016-1018 rb1 1020-1022 rrb1 1024-1026 cb3 1028-1030 rrb3 1032-1034 ugcb1 1036-1038 ug 1040-1061 ugm 1063-1065 ugt1 $ 1067-1070 ugcb2 1072-1074 ugt2 $ 1076-1079 ug1 1081-1102 ugm1 1104-1106 cb2 1108-1110 rb2 1112-1114 rrb2 1116-1118 pp1 1120-1122 score1 1124-1133 gz1 1135-1137 kz1 1139-1148 score2 1150-1159 text1 $ 1161-1200 text2 $ 1202-1321 zeit1 $ 1323-1328 datum1 $ 1330-1337 zeit2 $ 1339-1342 datum2 $ 1344-1349 ddd $ 1351-1358 random1 $ 1360-1364 hobbies1 1366-1375 haustier1 1377-1386 abcdefghijabcdefghij 1388-1390 cb4 1392-1394 rb3 1396-1398 rrb4 1400-1402 pp2 1404-1406 score3 1408-1417 farbe 1419-1421 hb7 1423-1425 hb9 1427-1429 hb8 1431-1433 bild1 1435-1444 bild2 1446-1455;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a.



rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kh. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fs. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cf. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_t. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lv. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_iy. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kx. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_jf. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_jq. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fr. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_cp. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_bj. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ugt2 LABEL='Meßzeitpunkt - HHMI' ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_le. cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ip. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_kz. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_y. pp1 LABEL='Popup - CODELIST' FORMAT=cl_lg. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' ddd LABEL='IASStandardGroup Zeitfelder - YYYYMMDD' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a. abcdefghijabcdefghij LABEL='Namenstest mit Regel - CODELIST' FORMAT=clcb. cb4 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cs. rb3 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_dg. rrb4 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_id. pp2 LABEL='Popup - CODELIST' FORMAT=cl_ff. score3 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bh. hb7 LABEL='Erste Reihe - CODELIST' FORMAT=cl_mh. hb9 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_fm. hb8 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bq. bild1 LABEL='Lieblingsbild' bild2 LABEL='und noch ein Bild';;run ;/* == end of atmnpias1komponenten == */

DATA mnpias1komponenten1 (label='Komponenten 1');infile 'dat/mnpias1komponenten1_IAS1_20080904-174021.dat' missover LRECL=1381;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt



mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131 mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 eppc1 $ 595-714 epcc2a $ 716-835 epcc2b $ 837-844 epcc2c $ 846-850 epcc2d $ 852-856 tier1 858-867 rasse1 869-878 farbe1 880-889 tier2 891-900 rasse2 902-911 farbe2 913-922 tier3 924-933 rasse3 935-944 farbe3 946-955 hb1 957-959 hb2 961-963 hb3 965-967 hb4 969-971 hb5 973-975 hb6 977-979 r1s1 981-983 r1s2 985-987 r1s3 989-991 r2s1 993-995 r2s2 997-999 r2s3 1001-1003 cb1 1005-1007 rb1 1009-1011 rrb1 1013-1015 cb3 1017-1019 rrb3 1021-1023 ugcb1 1025-1027 ug 1029-1050 ugm 1052-1054 ugt1 $ 1056-1059 ugcb2 1061-1063 ug1 1065-1086 ugm1 1088-1090 ugt2 $ 1092-1095 cb2 1097-1099 rb2 1101-1103 rrb2 1105-1107 pp1 1109-1111 score1 1113-1122 gz1 1124-1126 kz1 1128-1137 score2 1139-1148 text1 $ 1150-1189 text2 $ 1191-1310 zeit1 $ 1312-1317 datum1 $ 1319-1326 zeit2 $ 1328-1331 datum2 $ 1333-1338 random1 $ 1340-1344 hobbies1 1346-1355 haustier1 1357-1366 bild1 1368-1377;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID'



mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ku. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_jj. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_hg. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hb. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_cv. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mx. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_lx. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ke. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ib. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_en. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_co. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_lk. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ck. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kw. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_r. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_fy. pp1 LABEL='Popup - CODELIST' FORMAT=cl_da. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a. bild1 LABEL='Bild-1';;run ;



/* == end of mnpias1komponenten1 == */

DATA atmnpias1komponenten1 (label='Komponenten 1 (Audit-Records)');infile 'dat/atmnpias1komponenten1_IAS1_20080904-174021.dat' missover LRECL=1392;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 eppc1 $ 606-725 epcc2a $ 727-846 epcc2b $ 848-855 epcc2c $ 857-861 epcc2d $ 863-867 tier1 869-878 rasse1 880-889 farbe1 891-900 tier2 902-911 rasse2 913-922 farbe2 924-933 tier3 935-944 rasse3 946-955 farbe3 957-966 hb1 968-970 hb2 972-974 hb3 976-978 hb4 980-982 hb5 984-986 hb6 988-990 r1s1 992-994 r1s2 996-998 r1s3 1000-1002 r2s1 1004-1006 r2s2 1008-1010 r2s3 1012-1014 cb1 1016-1018 rb1 1020-1022 rrb1 1024-1026 cb3 1028-1030 rrb3 1032-1034 ugcb1 1036-1038 ug 1040-1061 ugm 1063-1065 ugt1 $ 1067-1070 ugcb2 1072-1074 ug1 1076-1097 ugm1 1099-1101 ugt2 $ 1103-1106 cb2 1108-1110 rb2 1112-1114 rrb2 1116-1118 pp1 1120-1122 score1 1124-1133 gz1 1135-1137 kz1 1139-1148 score2 1150-1159 text1 $ 1161-1200 text2 $ 1202-1321



zeit1 $ 1323-1328 datum1 $ 1330-1337 zeit2 $ 1339-1342 datum2 $ 1344-1349 random1 $ 1351-1355 hobbies1 1357-1366 haustier1 1368-1377 bild1 1379-1388;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ku. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_jj. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_hg. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hb. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_cv. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mx. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_lx. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ke. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ib. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_en. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_co. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_lk. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ck. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_kw. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_r. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_fy. pp1 LABEL='Popup - CODELIST' FORMAT=cl_da. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number'



gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a. bild1 LABEL='Bild-1';;run ;/* == end of atmnpias1komponenten1 == */

DATA mnpias1roentgen (label='Röntgenbilder');infile 'dat/mnpias1roentgen_IAS1_20080904-174021.dat' missover LRECL=792;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131 mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 titel $ 595-654 aufnahme $ 656-663 beschreibung $ 665-784 klinisch 786-788;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' titel LABEL='Titel' aufnahme LABEL='Aufnahmedatum - YYYYMMDD' beschreibung LABEL='Beschreibung'



klinisch LABEL='Klinisch auffällig? - CODELIST' FORMAT=cl_kv.;;run ;/* == end of mnpias1roentgen == */

DATA atmnpias1roentgen (label='Röntgenbilder (Audit-Records)');infile 'dat/atmnpias1roentgen_IAS1_20080904-174021.dat' missover LRECL=803;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 titel $ 606-665 aufnahme $ 667-674 beschreibung $ 676-795 klinisch 797-799;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' titel LABEL='Titel' aufnahme LABEL='Aufnahmedatum - YYYYMMDD' beschreibung LABEL='Beschreibung' klinisch LABEL='Klinisch auffällig? - CODELIST' FORMAT=cl_kv.;;run ;/* == end of atmnpias1roentgen == */

DATA mnpias1score (label='Score-Test');infile 'dat/mnpias1score_IAS1_20080904-174021.dat' missover LRECL=635;input mnppid 1-10



mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131 mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 sb1 595-597 vr1 599-601 score 603-612 score2 614-623 rb1 625-627 rb2 629-631;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' sb1 LABEL='horizontal radiobutton - CODELIST' FORMAT=cl_in. vr1 LABEL='vertical radiobutton - CODELIST' FORMAT=cl_ek. score LABEL='score berechnen - Number' score2 LABEL='score function - Number' rb1 LABEL='erste Frage - CODELIST' FORMAT=cl_cz. rb2 LABEL='zweite Frage - CODELIST' FORMAT=cl_d.;;run ;/* == end of mnpias1score == */

DATA atmnpias1score (label='Score-Test (Audit-Records)');infile 'dat/atmnpias1score_IAS1_20080904-174021.dat' missover LRECL=646;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt



@107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 sb1 606-608 vr1 610-612 score 614-623 score2 625-634 rb1 636-638 rb2 640-642;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' sb1 LABEL='horizontal radiobutton - CODELIST' FORMAT=cl_in. vr1 LABEL='vertical radiobutton - CODELIST' FORMAT=cl_ek. score LABEL='score berechnen - Number' score2 LABEL='score function - Number' rb1 LABEL='erste Frage - CODELIST' FORMAT=cl_cz. rb2 LABEL='zweite Frage - CODELIST' FORMAT=cl_d.;;run ;/* == end of atmnpias1score == */

DATA mnpias1bild (label='Standard-Bild');infile 'dat/mnpias1bild_IAS1_20080904-174021.dat' missover LRECL=676;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131



mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 farbe 595-597 zahl 599-600 wort $ 602-661 bild1 663-672;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_brl. zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild';;run ;/* == end of mnpias1bild == */

DATA atmnpias1bild (label='Standard-Bild (Audit-Records)');infile 'dat/atmnpias1bild_IAS1_20080904-174021.dat' missover LRECL=687;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 farbe 606-608



zahl 610-611 wort $ 613-672 bild1 674-683;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_brl. zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild';;run ;/* == end of atmnpias1bild == */

DATA mnpias1bild1 (label='Standard-Bild-2');infile 'dat/mnpias1bild1_IAS1_20080904-174021.dat' missover LRECL=676;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpfs0 115-116 mnpfs1 118-119 mnpfs2 121-122 mnpfs3 124-125 mnpfcs0 127-128 mnpfcs1 130-131 mnpfcs2 133-134 mnpfcs3 136-137 mnpfsqa 139-140 mnpfsct 142-143 mnpfssdv 145-146 siguser $ 148-347 sigtext $ 349-378 sigstatus 380-381 sigvalid $ 383-392 sigreason $ 394-593 farbe 595-597 zahl 599-600 wort $ 602-661 bild1 663-672;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID'



mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bsi. zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild';;run ;/* == end of mnpias1bild1 == */

DATA atmnpias1bild1 (label='Standard-Bild-2 (Audit-Records)');infile 'dat/atmnpias1bild1_IAS1_20080904-174021.dat' missover LRECL=687;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpfs0 126-127 mnpfs1 129-130 mnpfs2 132-133 mnpfs3 135-136 mnpfcs0 138-139 mnpfcs1 141-142 mnpfcs2 144-145 mnpfcs3 147-148 mnpfsqa 150-151 mnpfsct 153-154 mnpfssdv 156-157 siguser $ 159-358 sigtext $ 360-389 sigstatus 391-392 sigvalid $ 394-403 sigreason $ 405-604 farbe 606-608 zahl 610-611 wort $ 613-672 bild1 674-683;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x.



mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' farbe LABEL='Lieblingsfarbe - CODELIST' FORMAT=cl_bsi. zahl LABEL='Lieblingszahl - Number' wort LABEL='Lieblingswort' bild1 LABEL='Lieblingsbild';;run ;/* == end of atmnpias1bild1 == */

DATA mnpias1status (label='Patientenstatus');infile 'dat/mnpias1status_IAS1_20080904-174021.dat' missover LRECL=1308;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpfs0 53-54 mnpfs1 56-57 mnpfs2 59-60 mnpfs3 62-63 mnpfcs0 65-66 mnpfcs1 68-69 mnpfcs2 71-72 mnpfcs3 74-75 mnpfsqa 77-78 mnpfsct 80-81 mnpfssdv 83-84 siguser $ 86-285 sigtext $ 287-316 sigstatus 318-319 sigvalid $ 321-330 sigreason $ 332-531 eppc1 $ 533-652 epcc2a $ 654-773 epcc2b $ 775-782 epcc2c $ 784-788 epcc2d $ 790-794 tier1 796-805 rasse1 807-816 farbe1 818-827 tier2 829-838 rasse2 840-849 farbe2 851-860 tier3 862-871 rasse3 873-882 farbe3 884-893 hb1 895-897 hb2 899-901 hb3 903-905 hb4 907-909 hb5 911-913 hb6 915-917 r1s1 919-921 r1s2 923-925 r1s3 927-929 r2s1 931-933 r2s2 935-937 r2s3 939-941 cb1 943-945 rb1 947-949 rrb1 951-953 cb3 955-957 rrb3 959-961 ugcb1 963-965 ug 967-988 ugm 990-992 ugt1 $ 994-997 ugcb2 999-1001 ug1 1003-1024 ugm1 1026-1028 ugt2 $ 1030-1033



cb2 1035-1037 rb2 1039-1041 rrb2 1043-1045 pp1 1047-1049 score1 1051-1060 gz1 1062-1064 kz1 1066-1075 score2 1077-1086 text1 $ 1088-1127 text2 $ 1129-1248 zeit1 $ 1250-1255 datum1 $ 1257-1264 zeit2 $ 1266-1269 datum2 $ 1271-1276 random1 $ 1278-1282 hobbies1 1284-1293 haustier1 1295-1304;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_jn. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hz. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_kq. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hx. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hs. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mf. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_by. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_go. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_la. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_hh. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ht. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_jx. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_bi. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fa. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_if.



rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_eh. pp1 LABEL='Popup - CODELIST' FORMAT=cl_ep. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of mnpias1status == */

DATA atmnpias1status (label='Patientenstatus (Audit-Records)');infile 'dat/atmnpias1status_IAS1_20080904-174021.dat' missover LRECL=1319;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpfs0 64-65 mnpfs1 67-68 mnpfs2 70-71 mnpfs3 73-74 mnpfcs0 76-77 mnpfcs1 79-80 mnpfcs2 82-83 mnpfcs3 85-86 mnpfsqa 88-89 mnpfsct 91-92 mnpfssdv 94-95 siguser $ 97-296 sigtext $ 298-327 sigstatus 329-330 sigvalid $ 332-341 sigreason $ 343-542 eppc1 $ 544-663 epcc2a $ 665-784 epcc2b $ 786-793 epcc2c $ 795-799 epcc2d $ 801-805 tier1 807-816 rasse1 818-827 farbe1 829-838 tier2 840-849 rasse2 851-860 farbe2 862-871 tier3 873-882 rasse3 884-893 farbe3 895-904 hb1 906-908 hb2 910-912 hb3 914-916 hb4 918-920 hb5 922-924 hb6 926-928 r1s1 930-932 r1s2 934-936 r1s3 938-940 r2s1 942-944 r2s2 946-948 r2s3 950-952 cb1 954-956 rb1 958-960 rrb1 962-964 cb3 966-968 rrb3 970-972 ugcb1 974-976 ug 978-999 ugm 1001-1003 ugt1 $ 1005-1008 ugcb2 1010-1012



ug1 1014-1035 ugm1 1037-1039 ugt2 $ 1041-1044 cb2 1046-1048 rb2 1050-1052 rrb2 1054-1056 pp1 1058-1060 score1 1062-1071 gz1 1073-1075 kz1 1077-1086 score2 1088-1097 text1 $ 1099-1138 text2 $ 1140-1259 zeit1 $ 1261-1266 datum1 $ 1268-1275 zeit2 $ 1277-1280 datum2 $ 1282-1287 random1 $ 1289-1293 hobbies1 1295-1304 haustier1 1306-1315;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_jn. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hz. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_kq. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_hx. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hs. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_mf. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_by. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_go. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_la. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_hh. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_ht. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_jx. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number'



ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_bi. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fa. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_if. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_eh. pp1 LABEL='Popup - CODELIST' FORMAT=cl_ep. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of atmnpias1status == */

DATA mnpias1ae (label='Adverse Event');infile 'dat/mnpias1ae_IAS1_20080904-174021.dat' missover LRECL=1379;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpaeid 53-62 @64 mnpaedate mnpaeno 83-92 mnpaefuid 94-103 @105 mnpaefudt mnpfs0 124-125 mnpfs1 127-128 mnpfs2 130-131 mnpfs3 133-134 mnpfcs0 136-137 mnpfcs1 139-140 mnpfcs2 142-143 mnpfcs3 145-146 mnpfsqa 148-149 mnpfsct 151-152 mnpfssdv 154-155 siguser $ 157-356 sigtext $ 358-387 sigstatus 389-390 sigvalid $ 392-401 sigreason $ 403-602 eppc1 $ 604-723 epcc2a $ 725-844 epcc2b $ 846-853 epcc2c $ 855-859 epcc2d $ 861-865 tier1 867-876 rasse1 878-887 farbe1 889-898 tier2 900-909 rasse2 911-920 farbe2 922-931 tier3 933-942 rasse3 944-953 farbe3 955-964 hb1 966-968 hb2 970-972 hb3 974-976 hb4 978-980 hb5 982-984 hb6 986-988 r1s1 990-992 r1s2 994-996 r1s3 998-1000 r2s1 1002-1004 r2s2 1006-1008 r2s3 1010-1012 cb1 1014-1016 rb1 1018-1020



rrb1 1022-1024 cb3 1026-1028 rrb3 1030-1032 ugcb1 1034-1036 ug 1038-1059 ugm 1061-1063 ugt1 $ 1065-1068 ugcb2 1070-1072 ug1 1074-1095 ugm1 1097-1099 ugt2 $ 1101-1104 cb2 1106-1108 rb2 1110-1112 rrb2 1114-1116 pp1 1118-1120 score1 1122-1131 gz1 1133-1135 kz1 1137-1146 score2 1148-1157 text1 $ 1159-1198 text2 $ 1200-1319 zeit1 $ 1321-1326 datum1 $ 1328-1335 zeit2 $ 1337-1340 datum2 $ 1342-1347 random1 $ 1349-1353 hobbies1 1355-1364 haustier1 1366-1375;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kr. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_do. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bw. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_lf. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hn. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cr. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb.



r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_gm. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ee. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gn. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_iv. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_br. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dm. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ft. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ih. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fv. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_s. pp1 LABEL='Popup - CODELIST' FORMAT=cl_md. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of mnpias1ae == */

DATA atmnpias1ae (label='Adverse Event (Audit-Records)');infile 'dat/atmnpias1ae_IAS1_20080904-174021.dat' missover LRECL=1390;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpaeid 64-73 @75 mnpaedate mnpaeno 94-103 mnpaefuid 105-114 @116 mnpaefudt mnpfs0 135-136 mnpfs1 138-139 mnpfs2 141-142 mnpfs3 144-145 mnpfcs0 147-148 mnpfcs1 150-151 mnpfcs2 153-154 mnpfcs3 156-157 mnpfsqa 159-160 mnpfsct 162-163 mnpfssdv 165-166 siguser $ 168-367 sigtext $ 369-398 sigstatus 400-401 sigvalid $ 403-412 sigreason $ 414-613 eppc1 $ 615-734 epcc2a $ 736-855 epcc2b $ 857-864 epcc2c $ 866-870 epcc2d $ 872-876 tier1 878-887 rasse1 889-898 farbe1 900-909 tier2 911-920 rasse2 922-931 farbe2 933-942 tier3 944-953 rasse3 955-964 farbe3 966-975 hb1 977-979



hb2 981-983 hb3 985-987 hb4 989-991 hb5 993-995 hb6 997-999 r1s1 1001-1003 r1s2 1005-1007 r1s3 1009-1011 r2s1 1013-1015 r2s2 1017-1019 r2s3 1021-1023 cb1 1025-1027 rb1 1029-1031 rrb1 1033-1035 cb3 1037-1039 rrb3 1041-1043 ugcb1 1045-1047 ug 1049-1070 ugm 1072-1074 ugt1 $ 1076-1079 ugcb2 1081-1083 ug1 1085-1106 ugm1 1108-1110 ugt2 $ 1112-1115 cb2 1117-1119 rb2 1121-1123 rrb2 1125-1127 pp1 1129-1131 score1 1133-1142 gz1 1144-1146 kz1 1148-1157 score2 1159-1168 text1 $ 1170-1209 text2 $ 1211-1330 zeit1 $ 1332-1337 datum1 $ 1339-1346 zeit2 $ 1348-1351 datum2 $ 1353-1358 random1 $ 1360-1364 hobbies1 1366-1375 haustier1 1377-1386;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c.



tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_kr. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_do. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_bw. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_lf. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_hn. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_cr. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_gm. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_ee. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gn. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_iv. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_br. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dm. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_ft. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_ih. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fv. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_s. pp1 LABEL='Popup - CODELIST' FORMAT=cl_md. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of atmnpias1ae == */

DATA mnpias1sae1 (label='Serious Adverse Event');infile 'dat/mnpias1sae1_IAS1_20080904-174021.dat' missover LRECL=1379;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpaeid 53-62 @64 mnpaedate mnpaeno 83-92 mnpaefuid 94-103 @105 mnpaefudt mnpfs0 124-125 mnpfs1 127-128 mnpfs2 130-131 mnpfs3 133-134 mnpfcs0 136-137 mnpfcs1 139-140 mnpfcs2 142-143 mnpfcs3 145-146 mnpfsqa 148-149 mnpfsct 151-152 mnpfssdv 154-155 siguser $ 157-356 sigtext $ 358-387 sigstatus 389-390 sigvalid $ 392-401 sigreason $ 403-602 eppc1 $ 604-723 epcc2a $ 725-844



epcc2b $ 846-853 epcc2c $ 855-859 epcc2d $ 861-865 tier1 867-876 rasse1 878-887 farbe1 889-898 tier2 900-909 rasse2 911-920 farbe2 922-931 tier3 933-942 rasse3 944-953 farbe3 955-964 hb1 966-968 hb2 970-972 hb3 974-976 hb4 978-980 hb5 982-984 hb6 986-988 r1s1 990-992 r1s2 994-996 r1s3 998-1000 r2s1 1002-1004 r2s2 1006-1008 r2s3 1010-1012 cb1 1014-1016 rb1 1018-1020 rrb1 1022-1024 cb3 1026-1028 rrb3 1030-1032 ugcb1 1034-1036 ug 1038-1059 ugm 1061-1063 ugt1 $ 1065-1068 ugcb2 1070-1072 ug1 1074-1095 ugm1 1097-1099 ugt2 $ 1101-1104 cb2 1106-1108 rb2 1110-1112 rrb2 1114-1116 pp1 1118-1120 score1 1122-1131 gz1 1133-1135 kz1 1137-1146 score2 1148-1157 text1 $ 1159-1198 text2 $ 1200-1319 zeit1 $ 1321-1326 datum1 $ 1328-1335 zeit2 $ 1337-1340 datum2 $ 1342-1347 random1 $ 1349-1353 hobbies1 1355-1364 haustier1 1366-1375;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity'



sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_gt. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lq. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_nj. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ej. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_gi. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_gy. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cm. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fu. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gv. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_he. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_hf. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dx. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_f. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fk. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_mp. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_nd. pp1 LABEL='Popup - CODELIST' FORMAT=cl_bx. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of mnpias1sae1 == */

DATA atmnpias1sae1 (label='Serious Adverse Event (Audit-Records)');infile 'dat/atmnpias1sae1_IAS1_20080904-174021.dat' missover LRECL=1390;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpaeid 64-73 @75 mnpaedate mnpaeno 94-103 mnpaefuid 105-114 @116 mnpaefudt mnpfs0 135-136 mnpfs1 138-139 mnpfs2 141-142 mnpfs3 144-145 mnpfcs0 147-148



mnpfcs1 150-151 mnpfcs2 153-154 mnpfcs3 156-157 mnpfsqa 159-160 mnpfsct 162-163 mnpfssdv 165-166 siguser $ 168-367 sigtext $ 369-398 sigstatus 400-401 sigvalid $ 403-412 sigreason $ 414-613 eppc1 $ 615-734 epcc2a $ 736-855 epcc2b $ 857-864 epcc2c $ 866-870 epcc2d $ 872-876 tier1 878-887 rasse1 889-898 farbe1 900-909 tier2 911-920 rasse2 922-931 farbe2 933-942 tier3 944-953 rasse3 955-964 farbe3 966-975 hb1 977-979 hb2 981-983 hb3 985-987 hb4 989-991 hb5 993-995 hb6 997-999 r1s1 1001-1003 r1s2 1005-1007 r1s3 1009-1011 r2s1 1013-1015 r2s2 1017-1019 r2s3 1021-1023 cb1 1025-1027 rb1 1029-1031 rrb1 1033-1035 cb3 1037-1039 rrb3 1041-1043 ugcb1 1045-1047 ug 1049-1070 ugm 1072-1074 ugt1 $ 1076-1079 ugcb2 1081-1083 ug1 1085-1106 ugm1 1108-1110 ugt2 $ 1112-1115 cb2 1117-1119 rb2 1121-1123 rrb2 1125-1127 pp1 1129-1131 score1 1133-1142 gz1 1144-1146 kz1 1148-1157 score2 1159-1168 text1 $ 1170-1209 text2 $ 1211-1330 zeit1 $ 1332-1337 datum1 $ 1339-1346 zeit2 $ 1348-1351 datum2 $ 1353-1358 random1 $ 1360-1364 hobbies1 1366-1375 haustier1 1377-1386;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x.



mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' eppc1 LABEL='Operationsgruppe' epcc2a LABEL='Operation' epcc2b LABEL='EPCC' epcc2c LABEL='ICD-10' epcc2d LABEL='ICD-10 additional' tier1 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse1 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe1 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier2 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse2 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe2 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. tier3 LABEL='Haustier - CODELIST' FORMAT=cllt_a. rasse3 LABEL='Tier-Rasse - CODELIST' FORMAT=cllt_b. farbe3 LABEL='Tier-Farbe - CODELIST' FORMAT=cllt_c. hb1 LABEL='Erste Reihe - CODELIST' FORMAT=cl_gt. hb2 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_lq. hb3 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_nj. hb4 LABEL='Erste Reihe - CODELIST' FORMAT=cl_ej. hb5 LABEL='Zweite Reihe - CODELIST' FORMAT=cl_gi. hb6 LABEL='Dritte Reihe - CODELIST' FORMAT=cl_gy. r1s1 LABEL='Reihe eins rot - CODELIST' FORMAT=clcb. r1s2 LABEL='Reihe eins blau - CODELIST' FORMAT=clcb. r1s3 LABEL='Reihe eins grün - CODELIST' FORMAT=clcb. r2s1 LABEL='Reihe zwei rot - CODELIST' FORMAT=clcb. r2s2 LABEL='Reihe zwei blau - CODELIST' FORMAT=clcb. r2s3 LABEL='Reihe zwei grün - CODELIST' FORMAT=clcb. cb1 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_cm. rb1 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_fu. rrb1 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_gv. cb3 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_he. rrb3 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_hf. ugcb1 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug LABEL='Messwert (g) - Number' ugm LABEL='IASHorizontalUnitGroup - CODELIST' FORMAT=cl_dx. ugt1 LABEL='Meßzeitpunkt - HHMI' ugcb2 LABEL='Messung durchgeführt? - CODELIST' FORMAT=clcb. ug1 LABEL='Messwert (g) - Number' ugm1 LABEL='IASUnitGroup - CODELIST' FORMAT=cl_f. ugt2 LABEL='Meßzeitpunkt - HHMI' cb2 LABEL='einfache Checkbox - CODELIST' FORMAT=cl_fk. rb2 LABEL='einfacher RadioButton - CODELIST' FORMAT=cl_mp. rrb2 LABEL='Reset-Radiobutton - CODELIST' FORMAT=cl_nd. pp1 LABEL='Popup - CODELIST' FORMAT=cl_bx. score1 LABEL='Score über Auswahl-Optionen (Ganzzahlen) - Number' gz1 LABEL='Ganzzahl (3) - Number' kz1 LABEL='Kommazahl (5.3) - Number' score2 LABEL='Score über Zahlenfelder - Number' text1 LABEL='Kurzes Textfeld (40)' text2 LABEL='Langes Textfeld (Area, 3x40)' zeit1 LABEL='Zeitstempel - HHMISS' datum1 LABEL='Datum - YYYYMMDD' zeit2 LABEL='geprüfte Zeit - MISS' datum2 LABEL='geprüftes Datum - YYYYMM' random1 LABEL='Randomization-Button' hobbies1 LABEL='Erweiterbare Lookuptabelle - CODELIST' FORMAT=cllt_d. haustier1 LABEL='einfache Lookuptabelle (Haustier) - CODELIST' FORMAT=cllt_a.;;run ;/* == end of atmnpias1sae1 == */

DATA mnpias1bilder (label='Bilderformular mit besonders "langem Namen"');infile 'dat/mnpias1bilder_IAS1_20080904-174021.dat' missover LRECL=803;input mnppid 1-10



mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpaeid 115-124 @126 mnpaedate mnpaeno 145-154 mnpaefuid 156-165 @167 mnpaefudt @186 mnpcrtdt mnpcrtpt 205-214 mnpfs0 216-217 mnpfs1 219-220 mnpfs2 222-223 mnpfs3 225-226 mnpfcs0 228-229 mnpfcs1 231-232 mnpfcs2 234-235 mnpfcs3 237-238 mnpfsqa 240-241 mnpfsct 243-244 mnpfssdv 246-247 siguser $ 249-448 sigtext $ 450-479 sigstatus 481-482 sigvalid $ 484-493 sigreason $ 495-694 img 696-705 bild2 707-716 bezeichnung $ 718-777 img1 779-788 bild3 790-799;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='Bild a' bild2 LABEL='Bild b' bezeichnung LABEL='Bezeichnung' img1 LABEL='Bild c' bild3 LABEL='Bild d';;run ;/* == end of mnpias1bilder == */



DATA atmnpias1bilder (label='Bilderformular mit besonders "langem Namen" (Audit-Records)');infile 'dat/atmnpias1bilder_IAS1_20080904-174021.dat' missover LRECL=814;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpaeid 126-135 @137 mnpaedate mnpaeno 156-165 mnpaefuid 167-176 @178 mnpaefudt @197 mnpcrtdt mnpcrtpt 216-225 mnpfs0 227-228 mnpfs1 230-231 mnpfs2 233-234 mnpfs3 236-237 mnpfcs0 239-240 mnpfcs1 242-243 mnpfcs2 245-246 mnpfcs3 248-249 mnpfsqa 251-252 mnpfsct 254-255 mnpfssdv 257-258 siguser $ 260-459 sigtext $ 461-490 sigstatus 492-493 sigvalid $ 495-504 sigreason $ 506-705 img 707-716 bild2 718-727 bezeichnung $ 729-788 img1 790-799 bild3 801-810;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='Bild a' bild2 LABEL='Bild b' bezeichnung LABEL='Bezeichnung' img1 LABEL='Bild c'



bild3 LABEL='Bild d';;run ;/* == end of atmnpias1bilder == */

DATA mnpias1bilder1 (label='Röntgen');infile 'dat/mnpias1bilder1_IAS1_20080904-174021.dat' missover LRECL=770;input mnppid 1-10 mnpdocid 12-21 @23 mnplastedit mnpptnid 42-51 mnpvisid 53-62 mnpcvpid 64-73 mnpvisno 75-84 @86 mnpvispdt @96 mnpvisfdt mnpaeid 115-124 @126 mnpaedate mnpaeno 145-154 mnpaefuid 156-165 @167 mnpaefudt @186 mnpcrtdt mnpcrtpt 205-214 mnpfs0 216-217 mnpfs1 219-220 mnpfs2 222-223 mnpfs3 225-226 mnpfcs0 228-229 mnpfcs1 231-232 mnpfcs2 234-235 mnpfcs3 237-238 mnpfsqa 240-241 mnpfsct 243-244 mnpfssdv 246-247 siguser $ 249-448 sigtext $ 450-479 sigstatus 481-482 sigvalid $ 484-493 sigreason $ 495-694 img 696-705 aufnahme $ 707-766;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='erstes Bild' aufnahme LABEL='Aufnahme:';



;run ;/* == end of mnpias1bilder1 == */

DATA atmnpias1bilder1 (label='Röntgen (Audit-Records)');infile 'dat/atmnpias1bilder1_IAS1_20080904-174021.dat' missover LRECL=781;input mnppid 1-10 mnpdocid 12-21 mnpatdocid 23-32 @34 mnplastedit mnpptnid 53-62 mnpvisid 64-73 mnpcvpid 75-84 mnpvisno 86-95 @97 mnpvispdt @107 mnpvisfdt mnpaeid 126-135 @137 mnpaedate mnpaeno 156-165 mnpaefuid 167-176 @178 mnpaefudt @197 mnpcrtdt mnpcrtpt 216-225 mnpfs0 227-228 mnpfs1 230-231 mnpfs2 233-234 mnpfs3 236-237 mnpfcs0 239-240 mnpfcs1 242-243 mnpfcs2 245-246 mnpfcs3 248-249 mnpfsqa 251-252 mnpfsct 254-255 mnpfssdv 257-258 siguser $ 260-459 sigtext $ 461-490 sigstatus 492-493 sigvalid $ 495-504 sigreason $ 506-705 img 707-716 aufnahme $ 718-777;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Document-ID' mnpatdocid LABEL='ATDocument-ID' mnplastedit LABEL='Date of last edit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID' FORMAT=cltn. mnpvisid LABEL='Visit-ID' mnpcvpid LABEL='Patient visit-ID' mnpvisno LABEL='Patient visit number' mnpvispdt LABEL='Planned date of visit' INFORMAT=DATE9. FORMAT=DATE9. mnpvisfdt LABEL='Date of first data entry in visit' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeid LABEL='Adverse Event-ID' mnpaedate LABEL='Adverse Event date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpaeno LABEL='Adverse Event case number' mnpaefuid LABEL='Adverse Event Follow-up-ID' mnpaefudt LABEL='Adverse Event Follow-up date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtdt LABEL='Document create date' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpcrtpt LABEL='Document creator (participant)' FORMAT=cltn. mnpfs0 LABEL='Form status (Review A)' FORMAT=clfs_0x. mnpfs1 LABEL='Form status (Review B)' FORMAT=clfs_1x. mnpfs2 LABEL='Form status (Freeze)' FORMAT=clfs_2x. mnpfs3 LABEL='Form status (System-Freeze)' FORMAT=clfs_3x. mnpfcs0 LABEL='Form completion status' FORMAT=clfcs_0x. mnpfcs1 LABEL='Form validation status (error)' FORMAT=clfcs_1x. mnpfcs2 LABEL='Form validation status (warning)' FORMAT=clfcs_2x. mnpfcs3 LABEL='Data entry complete status' FORMAT=clfcs_3x. mnpfsqa LABEL='Form status Queries' FORMAT=clfqa. mnpfsct LABEL='Form status Comments' FORMAT=clct. mnpfssdv LABEL='Form status SDV' FORMAT=clfssdv. siguser LABEL='Signature user' sigtext LABEL='Signature text' sigstatus LABEL='Signature type' sigvalid LABEL='Signature validity' sigreason LABEL='Reason for modification' img LABEL='erstes Bild' aufnahme LABEL='Aufnahme:';



;run ;/* == end of atmnpias1bilder1 == */

DATA emnpias1medikament (label='Medikament');infile 'dat/emnpias1medikament_IAS1_20080904-174021.dat' missover LRECL=109;input mnppid 1-10 mnpdocid 12-21 mnpsubdocid 23-32 fgid 34-43 position 45-54 wirkstoff $ 56-95 dosis 97-103 einnahme $ 105-108;

ATTRIB mnppid LABEL='Patient-ID' mnpdocid LABEL='Parent document-ID' mnpsubdocid LABEL='Subdocument-ID' fgid LABEL='Question-ID of Repetition' position LABEL='Position in Repetition' wirkstoff LABEL='Wirkstoff' dosis LABEL='Dosis - Number' einnahme LABEL='Einnahmezeit - HHMI';

;run ;/* == end of emnpias1medikament== */

DATA atemnpias1medikament (label='Medikament');infile 'dat/atemnpias1medikament_IAS1_20080904-174021.dat' missover LRECL=109;input mnppid 1-10 mnpatdocid 12-21 mnpatsubdocid 23-32 fgid 34-43 position 45-54 wirkstoff $ 56-95 dosis 97-103 einnahme $ 105-108;

ATTRIB mnppid LABEL='Patient-ID' mnpatdocid LABEL='Parent ATDocument-ID' mnpatsubdocid LABEL='ATSubdocument-ID' fgid LABEL='Question-ID of Repetition' position LABEL='Position in Repetition' wirkstoff LABEL='Wirkstoff' dosis LABEL='Dosis - Number' einnahme LABEL='Einnahmezeit - HHMI';

;run ;/* == end of atemnpias1medikament== */

DATA images_ias1 (label='Images');infile 'dat/images_IAS1_20080904-174021.dat' missover LRECL=957;input mnpimgid 1-10 uploadedfilename $ 12-511 contenttype $ 513-552 imagesize 554-575 @577 uploaddate mnpptnid 596-605 originalfile $ 607-706 originalstatus $ 708-722 webfile $ 724-823 webstatus $ 825-839 thumbnailfile $ 841-940 webstatus $ 942-956;ATTRIB mnpimgid LABEL='Image-ID' uploadedfilename LABEL='Uploaded file' contenttype LABEL='Content type' imagesize LABEL='Image size (bytes)' uploaddate LABEL='Date of upload' INFORMAT=DATETIME18. FORMAT=DATETIME20. mnpptnid LABEL='Participant-ID'



originalfile LABEL='Original file name' originalstatus LABEL='Status of original file' webfile LABEL='Web file name' webstatus LABEL='Status of web file' thumbnailfile LABEL='Thumbnail file name' thumbnailstatus LABEL='Status of thumbnail file';;run;/* == end of images_ias1 == */

/* == end of file == */



9. Appendix A-2: SAS format (=code lists) exampleproc format;value cl_ku3 = 'grün'2 = 'blau'1 = 'rot';value cllt_d3 = 'Lesen'1 = 'Sport'2 = 'Faulenzen';value cl_co0 = 'nein'1 = 'ja';value cl_kx0 = 'no einheit'1 = 'yes einheit';value cl_cp0 = 'nein'1 = 'ja';value cl_kz0 = 'nein'1 = 'ja'3 = 'grün';value cl_cs0 = 'no einheit'1 = 'yes einheit';value cl_cr3 = 'grün'1 = 'rot'2 = 'blau';value cl_cv3 = 'grün'2 = 'blau'1 = 'rot';value clcs_3x1 = 'frozen';value cl_cz3 = 'grün'1 = 'rot'2 = 'blau';value cl_d3 = 'grün'1 = 'rot'2 = 'blau';value cl_le1 = 'g'2 = 'mol';value cl_lf1 = 'rot'3 = 'grün'2 = 'blau';value cl_lg1 = 'rot'2 = 'blau'3 = 'grün';value cl_da1 = 'rot'3 = 'grün'2 = 'blau';value cl_lk1 = 'g'2 = 'mol';



value cl_f1 = 'g'2 = 'mol';value cl_dg3 = 'grün'0 = 'nein'1 = 'ja';value cl_lq3 = 'grün'2 = 'blau'1 = 'rot';value cl_r0 = 'nein'1 = 'ja';value cl_s0 = 'nein'1 = 'ja';value cl_t2 = 'blau'1 = 'rot'3 = 'grün';value cl_la0 = 'nein'1 = 'ja';value cl_lv1 = 'rot'2 = 'blau'3 = 'grün';value cl_do3 = 'grün'1 = 'rot'2 = 'blau';value cl_lx0 = 'no einheit'1 = 'yes einheit';value cl_y1 = 'ja'0 = 'nein';value clhd0 = 'no'1 = 'yes';value cl_dx1 = 'g'2 = 'mol';value clcs_4x1 = 'deceased';value cl_md2 = 'blau'1 = 'rot'3 = 'grün';value cl_dm2 = 'mol'1 = 'g';value cl_mf3 = 'grün'2 = 'blau'1 = 'rot';value clfs_0x1 = 'medical review (A)';value cl_ee0 = 'nein'1 = 'ja'



;value clqa0 = ''1 = 'open'2 = 'answered'4 = 'resolved'8 = 'check again';value cl_ej2 = 'blau'1 = 'rot'3 = 'grün';value cl_ek5 = 'fünf'2 = 'zwei'4 = 'vier'1 = 'eins';value cl_en0 = 'no einheit'1 = 'yes einheit';value cl_mx1 = 'rot'2 = 'blau'3 = 'grün';value cl_brl2 = 'blau'3 = 'grün'1 = 'rot';value clcs_5x1 = 'Project: frozen';value cl_nd0 = 'nein'1 = 'ja';value clfs_1x1 = 'data review (B)';value cl_fa0 = 'no einheit'1 = 'yes einheit';value cl_nj1 = 'rot'3 = 'grün'2 = 'blau';value cllt_a2 = 'Pferd'3 = 'Hund'1 = 'Katze';value cllt_b6 = 'Araber'7 = 'Perser'4 = 'Hannoveraner'1 = 'Schäferhund'3 = 'Kurzhaar'5 = 'Siam'2 = 'Dackel';value cllt_c14 = 'Schimmel'15 = 'braun-schwarz'11 = 'Palomino'3 = 'tabby'12 = 'rot'1 = 'getigert'5 = 'blau'7 = 'weiß'2 = 'braun'4 = 'schwarz-weiß'13 = 'braun'16 = 'bunt'8 = 'rot'



6 = 'braun'9 = 'Rappe'10 = 'schwarz';value cl_ff3 = 'grün'2 = 'blau'1 = 'rot';value cl_fk0 = 'no einheit'1 = 'yes einheit';value cl_fm2 = 'blau'3 = 'grün'1 = 'rot';value cl_ep1 = 'rot'3 = 'grün'2 = 'blau';value cl_bsi1 = 'rot'2 = 'blau'3 = 'grün';value cl_fs2 = 'blau'1 = 'rot'3 = 'grün';value cl_ft1 = 'g'2 = 'mol';value cl_fu1 = 'ja'0 = 'nein';value cl_fv0 = 'nein'1 = 'ja';value clcs_6x1 = 'Project: to be deleted';value cl_fy0 = 'nein'1 = 'ja';value cl_he0 = 'no einheit'1 = 'yes einheit';value clfs_2x1 = 'manual freeze';value cl_gi1 = 'rot'2 = 'blau'3 = 'grün';value cl_gm0 = 'no einheit'1 = 'yes einheit';value cl_gn0 = 'nein'1 = 'ja';value cl_go1 = 'ja'0 = 'nein';value cl_kv1 = 'ja'0 = 'nein'3 = 'unklar'



;value cl_kw0 = 'no einheit'1 = 'yes einheit';value cl_gv0 = 'nein'1 = 'ja';value clcs_7x1 = 'Project: visit plan closed';value clcb0 = 'no'1 = 'yes';value cl_eh1 = 'ja'0 = 'nein';value clfs_3x1 = 'rulebased freeze';value clfssdv1 = 'not done'2 = 'not necessary'4 = 'not possible'8 = 'deferred'16 = 'in progress'32 = 'verified'64 = 'verified with errors';value cl_hb3 = 'grün'2 = 'blau'1 = 'rot';value cl_fr0 = 'no einheit'1 = 'yes einheit';value cl_hf0 = 'nein'1 = 'ja';value cl_hg3 = 'grün'1 = 'rot'2 = 'blau';value cl_hh0 = 'no einheit'1 = 'yes einheit';value clfcs_1x1 = 'with errors';value clct0 = ''1 = 'with comment';value cl_hn3 = 'grün'1 = 'rot'2 = 'blau';value cl_hs3 = 'grün'2 = 'blau'1 = 'rot';value cl_ht1 = 'ja'0 = 'nein';value cltn1 = 'Dipl. biol. Susanne Schneider'151 = 'Dr. Ulrike Jonas';value cl_hx



2 = 'blau'3 = 'grün'1 = 'rot';value cl_hz1 = 'rot'3 = 'grün'2 = 'blau';value clcs_0x1 = 'not shown';value cl_ib0 = 'nein'1 = 'ja';value cl_id0 = 'nein'1 = 'ja';value clfcs_0x0 = 'empty'2 = 'partly filled'4 = 'completely filled';value cl_if1 = 'ja'0 = 'nein';value cl_ih0 = 'no einheit'1 = 'yes einheit';value clfcs_2x1 = 'with warnings';value cl_in3 = 'drei'2 = 'zwei'1 = 'eins';value cl_ip0 = 'no einheit'1 = 'yes einheit';value cl_iv0 = 'no einheit'1 = 'yes einheit';value cl_gt2 = 'blau'3 = 'grün'1 = 'rot';value cl_iy1 = 'rot'2 = 'blau'3 = 'grün';value cl_mh2 = 'blau'3 = 'grün'1 = 'rot';value cl_bi2 = 'mol'1 = 'g';value cl_gy2 = 'blau'1 = 'rot'3 = 'grün';value clcs_1x1 = 'delete pseudonym';value cl_jf0 = 'nein'1 = 'ja';



value cl_mp0 = 'nein'1 = 'ja';value cl_jj2 = 'blau'1 = 'rot'3 = 'grün';value clfcs_3x1 = 'data entry complete';value cl_jn3 = 'grün'1 = 'rot'2 = 'blau';value cl_bh2 = 'blau'3 = 'grün'1 = 'rot';value cl_jq1 = 'ja'0 = 'nein';value cl_bj1 = 'g'2 = 'mol';value cl_bx1 = 'rot'2 = 'blau'3 = 'grün';value clfqa0 = 'without query'1 = 'with open query'2 = 'with answered query'4 = 'all queries resolved'8 = 'all queries resolved';value cl_jx2 = 'mol'1 = 'g';value cl_bq3 = 'grün'1 = 'rot'2 = 'blau';value cl_br0 = 'nein'1 = 'ja';value clvt0 = 'fixed'1 = 'flexible'2 = 'unscheduled'3 = 'free';value cl_bw2 = 'blau'3 = 'grün'1 = 'rot';value clcs_2x1 = 'frozen';value cl_by0 = 'no einheit'1 = 'yes einheit';value cl_ke0 = 'nein'1 = 'ja';value cl_kh2 = 'blau'1 = 'rot'



3 = 'grün';value cl_cf1 = 'rot'2 = 'blau'3 = 'grün';value cl_kq3 = 'grün'1 = 'rot'2 = 'blau';value cl_kr2 = 'blau'1 = 'rot'3 = 'grün';value cl_ck2 = 'mol'1 = 'g';value cl_cm0 = 'no einheit'1 = 'yes einheit';



10. Appendix B: SPSS syntax example* created 04.09.2008 (CEST) by susanne ** project 'Basisregister' ** centre 'Berlin' *

GET DATA /TYPE = TXT /FILE = 'dat/visitplan_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpvisid F10.0 visitnumber F4.0 visittype F2.0 previsid F10.0 visitday EDATE10 minusoffset F10.0 plusoffset F10.0 visitlabel A50 .VARIABLE LABELS mnpvisid 'Visit-ID' visitnumber 'Visit sequence' visittype 'Type of visit' previsid 'Preceding visit-ID' visitday 'Time lag to preceding visit (days)' minusoffset 'Possible negative time frame (days)' plusoffset 'Possible positive time frame (days)' visitlabel 'Visit label' .VALUE LABEL visittype 0 'fixed' 1 'flexible' 2 'unscheduled' 3 'free' .CACHE.EXECUTE.DATASET NAME visitplan_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/visitplanforms_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpvisid F10.0 formid F10.0 .VARIABLE LABELS mnpvisid 'Visit-ID' formid 'Form-ID' .CACHE.EXECUTE.DATASET NAME visitplanforms_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/forms_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = formid F10.0 formtablename A24



hidden F2.0 formname A200 formfamily A100 sequence F10.0 .VARIABLE LABELS formid 'Form-ID' formtablename 'DB table name' hidden 'hidden in DataCapture' formname 'Form name (as in matrix)' formfamily 'Form family name' sequence 'Form sequence in form family' .VALUE LABEL hidden 0 'no' 1 'yes' .CACHE.EXECUTE.DATASET NAME forms_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/questions_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = fgid F10.0 formid F10.0 sequence F10.0 hidden F2.0 fglabel A200 .VARIABLE LABELS fgid 'Question-ID' formid 'Form-ID' sequence 'Question sequence in form' hidden 'hidden in DataCapture' fglabel 'Question label (or unique label for search)' .VALUE LABEL hidden 0 'no' 1 'yes' .CACHE.EXECUTE.DATASET NAME questions_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/items_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = ffid F10.0 fgid F10.0 sequence F10.0 ffcolname A32 hidden F2.0 fflabel A1500 lookuptable A30 .VARIABLE LABELS ffid 'Item-ID' fgid 'Question-ID' sequence 'Item sequence in question' ffcolname 'DB column name' hidden 'hidden in DataCapture' fflabel 'Item label (or question label or unique label for search)' lookuptable 'Name of lookup table'



.VALUE LABEL hidden 0 'no' 1 'yes' .CACHE.EXECUTE.DATASET NAME items_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/centres_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpctrid F10.0 mnpctrname A100 mnpcname A200 .VARIABLE LABELS mnpctrid 'Centre-ID' mnpctrname 'Centre name' mnpcname 'Country name' .CACHE.EXECUTE.DATASET NAME centres_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/casenodes_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnppsd A20 mnpptnid F10.0 mnpctrid F10.0 mnpcs0 F2.0 mnpcs1 F2.0 mnpcs2 F2.0 mnpcs3 F2.0 mnpcs4 F2.0 mnpcs5 F2.0 mnpcs6 F2.0 mnpcs7 F2.0 visitstartdate EDATE10 .VARIABLE LABELS mnppid 'Patient-ID' mnppsd 'Patient pseudonym' mnpptnid 'Participant-ID' mnpctrid 'Centre-ID' mnpcs0 'Case status 0' mnpcs1 'Case status 1' mnpcs2 'Case status 2' mnpcs3 'Case status 3' mnpcs4 'Case status 4' mnpcs5 'Case status 5' mnpcs6 'Case status 6' mnpcs7 'Case status 7' visitstartdate 'Entry date' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpcs0 0 '' 1 'not shown'



.VALUE LABEL mnpcs1 0 '' 1 'delete pseudonym' .VALUE LABEL mnpcs2 0 '' 1 'frozen' .VALUE LABEL mnpcs3 0 '' 1 'frozen' .VALUE LABEL mnpcs4 0 '' 1 'deceased' .VALUE LABEL mnpcs5 0 '' 1 'Project: frozen' .VALUE LABEL mnpcs6 0 '' 1 'Project: to be deleted' .VALUE LABEL mnpcs7 0 '' 1 'Project: visit plan closed' .CACHE.EXECUTE.DATASET NAME casenodes_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atcasenodes_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 oldvisitstartdate EDATE10 newvisitstartdate EDATE10 mnpptnid F10.0 changedate DATETIME23.2 changereason A200 .VARIABLE LABELS mnppid 'Patient-ID' oldvisitstartdate 'Old entry date' newvisitstartdate 'New entry date' mnpptnid 'Participant-ID' changedate 'Date of change' changereason 'Reason for change' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .CACHE.EXECUTE.DATASET NAME atcasenodes_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atcasevisitplans_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpcvpid F10.0



oldmnpvispdt EDATE10 newmnpvispdt EDATE10 oldmnpvisid F10.0 newmnpvisid F10.0 oldmnpvisno F10.0 newmnpvisno F10.0 mnpptnid F10.0 changedate DATETIME23.2 changereason A200 .VARIABLE LABELS mnppid 'Patient-ID' mnpcvpid 'Patient visit-ID' oldmnpvispdt 'Old planned date of visit' newmnpvispdt 'New planned date of visit' oldmnpvisid 'Old visit-ID' newmnpvisid 'New visit-ID' oldmnpvisno 'Old patient-visit number' newmnpvisno 'New patient-visit number' mnpptnid 'Participant-ID' changedate 'Date of change' changereason 'Reason for change' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .CACHE.EXECUTE.DATASET NAME atcasevisitplans_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/queries_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 ffid F10.0 ffcolname A32 qacdate DATETIME23.2 mnpqueryid F10.0 querytype A1 querystatus F2.0 qacstatus F2.0 mnpptnid F10.0 qaccontent A1000 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' qacdate 'Date of entry' mnpqueryid 'Query-ID' querytype 'Query type (manual or automatic)' querystatus 'Query status (calculated status)' qacstatus 'QAC status (type of query-entry)' mnpptnid 'Participant-ID' qaccontent 'Content' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL querystatus 0 '' 1 'open' 2 'answered' 4 'resolved' 8 'check again' .VALUE LABEL qacstatus 0 ''



1 'open' 2 'answered' 4 'resolved' 8 'check again' .CACHE.EXECUTE.DATASET NAME queries_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/comments_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 ffid F10.0 ffcolname A32 qacdate DATETIME23.2 mnpcommentid F10.0 mnpptnid F10.0 qaccontent A1000 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' qacdate 'Date of entry' mnpcommentid 'Comment-ID' mnpptnid 'Participant-ID' qaccontent 'Content' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .CACHE.EXECUTE.DATASET NAME comments_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/sdv_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 ffid F10.0 ffcolname A32 sdvdate DATETIME23.2 mnpfssdv F2.0 mnpptnid F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' ffid 'Item-ID' ffcolname 'DB column name' sdvdate 'Date of entry' mnpfssdv 'Status SDV' mnpptnid 'Participant-ID' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfssdv



1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .CACHE.EXECUTE.DATASET NAME sdv_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atsdv_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpatdocid F10.0 ffid F10.0 ffcolname A32 sdvdate DATETIME23.2 mnpfssdv F2.0 mnpptnid F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpatdocid 'ATDocument-ID' ffid 'Item-ID' ffcolname 'DB column name' sdvdate 'Date of entry' mnpfssdv 'Status SDV' mnpptnid 'Participant-ID' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .CACHE.EXECUTE.DATASET NAME atsdv_ias1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1komponenten_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0



mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ugt2 A4 ug1 F22.0 ugm1 F10.0 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 ddd A8 random1 A5 hobbies1 F10.0 haustier1 F10.0 abcdefghijabcdefghij F2.0 cb4 F2.0 rb3 F10.0 rrb4 F10.0 pp2 F10.0 score3 F10.0 farbe F10.0 hb7 F10.0 hb9 F10.0 hb8 F10.0



bild1 F10.0 bild2 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ugt2 'c) Meßzeitpunkt' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum'



zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' ddd '16. IASStandardGroup Zeitfelder' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' abcdefghijabcdefghij 'Namenstest mit Regel' cb4 'a) einfache Checkbox' rb3 'b) einfacher RadioButton' rrb4 'c) Reset-Radiobutton' pp2 'e) Popup' score3 'f) Score über Auswahl-Optionen (Ganzzahlen)' farbe 'Lieblingsfarbe' hb7 'a) Erste Reihe' hb9 'b) Zweite Reihe' hb8 'c) Dritte Reihe' bild1 'a) Lieblingsbild' bild2 'b) und noch ein Bild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .



VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun'



7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes'



.VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' 3 'grün' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL abcdefghijabcdefghij 0 'no' 1 'yes' .VALUE LABEL cb4 0 'no' 1 'yes' .VALUE LABEL rb3 1 'ja' 0 'nein' 3 'grün' .VALUE LABEL rrb4 1 'ja' 0 'nein' .VALUE LABEL pp2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb7 1 'rot' 3 'grün' 2 'blau'



.VALUE LABEL hb9 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb8 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME mnpias1komponenten WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1komponenten_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0



rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ugt2 A4 ug1 F22.0 ugm1 F10.0 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 ddd A8 random1 A5 hobbies1 F10.0 haustier1 F10.0 abcdefghijabcdefghij F2.0 cb4 F2.0 rb3 F10.0 rrb4 F10.0 pp2 F10.0 score3 F10.0 farbe F10.0 hb7 F10.0 hb9 F10.0 hb8 F10.0 bild1 F10.0 bild2 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe'



tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ugt2 'c) Meßzeitpunkt' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' ddd '16. IASStandardGroup Zeitfelder' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' abcdefghijabcdefghij 'Namenstest mit Regel' cb4 'a) einfache Checkbox' rb3 'b) einfacher RadioButton' rrb4 'c) Reset-Radiobutton' pp2 'e) Popup' score3 'f) Score über Auswahl-Optionen (Ganzzahlen)' farbe 'Lieblingsfarbe' hb7 'a) Erste Reihe' hb9 'b) Zweite Reihe' hb8 'c) Dritte Reihe' bild1 'a) Lieblingsbild' bild2 'b) und noch ein Bild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .



VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser'



.VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau'



.VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' 3 'grün' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1



1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL abcdefghijabcdefghij 0 'no' 1 'yes' .VALUE LABEL cb4 0 'no' 1 'yes' .VALUE LABEL rb3 1 'ja' 0 'nein' 3 'grün' .VALUE LABEL rrb4 1 'ja' 0 'nein' .VALUE LABEL pp2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb7 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb9 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb8 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME atmnpias1komponenten WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1komponenten1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0



mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)'



mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' bild1 'Bild-1' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled'



4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt'



.VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .



VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2



1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME mnpias1komponenten1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1komponenten1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0



hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier'



rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' bild1 'Bild-1' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3



0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino'



12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .



VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME atmnpias1komponenten1 WINDOW = FRONT .



GET DATA /TYPE = TXT /FILE = 'dat/mnpias1roentgen_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 titel A60 aufnahme A8 beschreibung A120 klinisch F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' titel 'Titel' aufnahme 'Aufnahmedatum' beschreibung 'Beschreibung' klinisch 'Klinisch auffällig?' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .



VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL klinisch 1 'ja' 0 'nein' 3 'unklar' .CACHE.EXECUTE.DATASET NAME mnpias1roentgen WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1roentgen_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0



mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 titel A60 aufnahme A8 beschreibung A120 klinisch F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' titel 'Titel' aufnahme 'Aufnahmedatum' beschreibung 'Beschreibung' klinisch 'Klinisch auffällig?' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2



0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL klinisch 1 'ja' 0 'nein' 3 'unklar' .CACHE.EXECUTE.DATASET NAME atmnpias1roentgen WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1score_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 sb1 F10.0 vr1 F10.0 score F10.0 score2 F10.0 rb1 F10.0 rb2 F10.0 .VARIABLE LABELS mnppid 'Patient-ID'



mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' sb1 'horizontal radiobutton' vr1 'vertical radiobutton' score 'score berechnen' score2 'score function' rb1 'erste Frage' rb2 'zweite Frage' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query'



2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL sb1 1 'eins' 2 'zwei' 3 'drei' .VALUE LABEL vr1 1 'eins' 2 'zwei' 5 'fünf' 4 'vier' .VALUE LABEL rb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL rb2 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME mnpias1score WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1score_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 sb1 F10.0 vr1 F10.0 score F10.0 score2 F10.0 rb1 F10.0 rb2 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID'



mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' sb1 'horizontal radiobutton' vr1 'vertical radiobutton' score 'score berechnen' score2 'score function' rb1 'erste Frage' rb2 'zweite Frage' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query'



4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL sb1 1 'eins' 2 'zwei' 3 'drei' .VALUE LABEL vr1 1 'eins' 2 'zwei' 5 'fünf' 4 'vier' .VALUE LABEL rb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL rb2 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME atmnpias1score WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bild_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 farbe F10.0 zahl F2.0 wort A60 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence'



mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL farbe



1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME mnpias1bild WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bild_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 farbe F10.0 zahl F2.0 wort A60 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort'



bild1 'Lieblingsbild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME atmnpias1bild WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bild1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0



mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 farbe F10.0 zahl F2.0 wort A60 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .



VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME mnpias1bild1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bild1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30



sigreason A200 farbe F10.0 zahl F2.0 wort A60 bild1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' farbe 'Lieblingsfarbe' zahl 'Lieblingszahl' wort 'Lieblingswort' bild1 'Lieblingsbild' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred'



16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL farbe 1 'rot' 3 'grün' 2 'blau' .CACHE.EXECUTE.DATASET NAME atmnpias1bild1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1status_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0



cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton'



rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved'



.VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam'



6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1



1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME mnpias1status WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1status_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpfs0 F2.0 mnpfs1 F2.0



mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)'



mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1



0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze'



2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün'



2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .



VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME atmnpias1status WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1ae_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0



r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe'



hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible'



8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3



1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes'



.VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME mnpias1ae WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1ae_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED



/FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8



zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder'



text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .



VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz'



16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .



VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME atmnpias1ae WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1sae1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120



epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0 ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type'



sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox' rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .



VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser'



.VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau'



.VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport'



2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME mnpias1sae1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1sae1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 eppc1 A120 epcc2a A120 epcc2b A8 epcc2c A5 epcc2d A5 tier1 F10.0 rasse1 F10.0 farbe1 F10.0 tier2 F10.0 rasse2 F10.0 farbe2 F10.0 tier3 F10.0 rasse3 F10.0 farbe3 F10.0 hb1 F10.0 hb2 F10.0 hb3 F10.0 hb4 F10.0 hb5 F10.0 hb6 F10.0 r1s1 F2.0 r1s2 F2.0 r1s3 F2.0 r2s1 F2.0 r2s2 F2.0 r2s3 F2.0 cb1 F2.0 rb1 F10.0 rrb1 F10.0 cb3 F2.0 rrb3 F10.0



ugcb1 F2.0 ug F22.0 ugm F10.0 ugt1 A4 ugcb2 F2.0 ug1 F22.0 ugm1 F10.0 ugt2 A4 cb2 F2.0 rb2 F10.0 rrb2 F10.0 pp1 F10.0 score1 F10.0 gz1 F3.0 kz1 F10.3 score2 F10.0 text1 A40 text2 A120 zeit1 A6 datum1 A8 zeit2 A4 datum2 A6 random1 A5 hobbies1 F10.0 haustier1 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' eppc1 'a) Operationsgruppe' epcc2a 'b) Operation' epcc2b 'c) EPCC' epcc2c 'd) ICD-10' epcc2d 'e) ICD-10 additional' tier1 'a) Haustier' rasse1 'b) Tier-Rasse' farbe1 'c) Tier-Farbe' tier2 'a) Haustier' rasse2 'b) Tier-Rasse' farbe2 'c) Tier-Farbe' tier3 'a) Haustier' rasse3 'b) Tier-Rasse' farbe3 'c) Tier-Farbe' hb1 'a) Erste Reihe' hb2 'b) Zweite Reihe' hb3 'c) Dritte Reihe' hb4 'a) Erste Reihe' hb5 'b) Zweite Reihe' hb6 'c) Dritte Reihe' r1s1 'a) Reihe eins - rot' r1s2 'a) Reihe eins - blau' r1s3 'a) Reihe eins - grün' r2s1 'b) Reihe zwei - rot' r2s2 'b) Reihe zwei - blau' r2s3 'b) Reihe zwei - grün' cb1 'a) einfache Checkbox'



rb1 'b) einfacher RadioButton' rrb1 'c) Reset-Radiobutton' cb3 'a) einfache Checkbox' rrb3 'c) Reset-Radiobutton' ugcb1 'a) Messung durchgeführt?' ug 'b) Messwert' ugm '12. IASHorizontalUnitGroup' ugt1 'c) Meßzeitpunkt' ugcb2 'a) Messung durchgeführt?' ug1 'b) Messwert' ugm1 '13. IASUnitGroup' ugt2 'c) Meßzeitpunkt' cb2 'a) einfache Checkbox' rb2 'b) einfacher RadioButton' rrb2 'c) Reset-Radiobutton' pp1 'e) Popup' score1 'f) Score über Auswahl-Optionen (Ganzzahlen)' gz1 'a) Ganzzahl (3)' kz1 'b) Kommazahl (5.3)' score2 'c) Score über Zahlenfelder' text1 'd) Kurzes Textfeld (40)' text2 'e) Langes Textfeld (Area, 3x40)' zeit1 'a) Zeitstempel' datum1 'b) Datum' zeit2 'c) geprüfte Zeit' datum2 'd) geprüftes Datum' random1 'a) Randomization-Button' hobbies1 'b) Erweiterbare Lookuptabelle' haustier1 'c) einfache Lookuptabelle (Haustier)' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query'



4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .VALUE LABEL tier1 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse1 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe1 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier2 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse2 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner' 5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe2 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL tier3 1 'Katze' 2 'Pferd' 3 'Hund' .VALUE LABEL rasse3 1 'Schäferhund' 2 'Dackel' 3 'Kurzhaar' 4 'Hannoveraner'



5 'Siam' 6 'Araber' 7 'Perser' .VALUE LABEL farbe3 1 'getigert' 2 'braun' 3 'tabby' 4 'schwarz-weiß' 5 'blau' 6 'braun' 7 'weiß' 8 'rot' 9 'Rappe' 10 'schwarz' 11 'Palomino' 12 'rot' 13 'braun' 14 'Schimmel' 15 'braun-schwarz' 16 'bunt' .VALUE LABEL hb1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb2 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb3 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb4 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb5 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hb6 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL r1s1 0 'no' 1 'yes' .VALUE LABEL r1s2 0 'no' 1 'yes' .VALUE LABEL r1s3 0 'no' 1 'yes' .VALUE LABEL r2s1 0 'no' 1 'yes' .VALUE LABEL r2s2 0 'no' 1 'yes' .VALUE LABEL r2s3 0 'no' 1 'yes' .VALUE LABEL cb1 0 'no' 1 'yes' .



VALUE LABEL rb1 1 'ja' 0 'nein' .VALUE LABEL rrb1 1 'ja' 0 'nein' .VALUE LABEL cb3 0 'no' 1 'yes' .VALUE LABEL rrb3 1 'ja' 0 'nein' .VALUE LABEL ugcb1 0 'no' 1 'yes' .VALUE LABEL ugm 2 'mol' 1 'g' .VALUE LABEL ugcb2 0 'no' 1 'yes' .VALUE LABEL ugm1 2 'mol' 1 'g' .VALUE LABEL cb2 0 'no' 1 'yes' .VALUE LABEL rb2 1 'ja' 0 'nein' .VALUE LABEL rrb2 1 'ja' 0 'nein' .VALUE LABEL pp1 1 'rot' 3 'grün' 2 'blau' .VALUE LABEL hobbies1 1 'Sport' 2 'Faulenzen' 3 'Lesen' .VALUE LABEL haustier1 1 'Katze' 2 'Pferd' 3 'Hund' .CACHE.EXECUTE.DATASET NAME atmnpias1sae1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bilder_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0



mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpcrtdt DATETIME23.2 mnpcrtpt F10.0 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 img F10.0 bild2 F10.0 bezeichnung A60 img1 F10.0 bild3 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1) Bild a' bild2 '2) Bild b' bezeichnung 'Bezeichnung' img1 'Bild c' bild3 'Bild d' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpcrtpt 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0



0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .CACHE.EXECUTE.DATASET NAME mnpias1bilder WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bilder_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0



mnpaefudt DATETIME23.2 mnpcrtdt DATETIME23.2 mnpcrtpt F10.0 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 img F10.0 bild2 F10.0 bezeichnung A60 img1 F10.0 bild3 F10.0 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1) Bild a' bild2 '2) Bild b' bezeichnung 'Bezeichnung' img1 'Bild c' bild3 'Bild d' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpcrtpt 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 ''



1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .CACHE.EXECUTE.DATASET NAME atmnpias1bilder WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/mnpias1bilder1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpcrtdt DATETIME23.2 mnpcrtpt F10.0 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0



mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 img F10.0 aufnahme A60 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1)' aufnahme 'Aufnahme:' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpcrtpt 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .



VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .CACHE.EXECUTE.DATASET NAME mnpias1bilder1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atmnpias1bilder1_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpatdocid F10.0 mnplastedit DATETIME23.2 mnpptnid F10.0 mnpvisid F10.0 mnpcvpid F10.0 mnpvisno F10.0 mnpvispdt EDATE10 mnpvisfdt DATETIME23.2 mnpaeid F10.0 mnpaedate DATETIME23.2 mnpaeno F10.0 mnpaefuid F10.0 mnpaefudt DATETIME23.2 mnpcrtdt DATETIME23.2 mnpcrtpt F10.0 mnpfs0 F2.0 mnpfs1 F2.0 mnpfs2 F2.0 mnpfs3 F2.0 mnpfcs0 F2.0 mnpfcs1 F2.0 mnpfcs2 F2.0 mnpfcs3 F2.0 mnpfsqa F2.0 mnpfsct F2.0 mnpfssdv F2.0 siguser A200 sigtext A30 sigstatus F2.0 sigvalid A30 sigreason A200 img F10.0



aufnahme A60 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid 'Document-ID' mnpatdocid 'ATDocument-ID' mnplastedit 'Date of last edit' mnpptnid 'Participant-ID' mnpvisid 'Visit-ID' mnpcvpid 'Patient visit-ID' mnpvisno'Visit sequence' mnpvispdt 'Planned date of visit' mnpvisfdt 'Date of first data entry in visit' mnpaeid 'Adverse Event-ID' mnpaedate 'Adverse Event date' mnpaeno 'Adverse Event case number' mnpaefuid 'Adverse Event Follow-up-ID' mnpaefudt 'Adverse Event Follow-up date' mnpcrtdt 'Document create date' mnpcrtpt 'Document creator (participant)' mnpfs0 'Form status (Review A)' mnpfs1 'Form status (Review B)' mnpfs2 'Form status (Freeze)' mnpfs3 'Form status (System-Freeze)' mnpfcs0 'Form completion status' mnpfcs1 'Form validation status (error)' mnpfcs2 'Form validation status (warning)' mnpfcs3 'Data entry complete status' mnpfsqa 'Form status Queries' mnpfsct 'Form status Comments' mnpfssdv 'Status SDV' siguser 'Signature user' sigtext 'Signature text' sigstatus 'Signature type' sigvalid 'Signature validity' sigreason 'Reason for modification' img '1)' aufnahme 'Aufnahme:' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpcrtpt 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .VALUE LABEL mnpfcs0 0 'empty' 2 'partly filled' 4 'completely filled' .VALUE LABEL mnpfcs1 0 '' 1 'with errors' .VALUE LABEL mnpfcs2 0 '' 1 'with warnings' .VALUE LABEL mnpfcs3 0 '' 1 'data entry complete' .VALUE LABEL mnpfs0 0 '' 1 'medical review (A)' .VALUE LABEL mnpfs1 0 '' 1 'data review (B)' .VALUE LABEL mnpfs2 0 '' 1 'manual freeze' .VALUE LABEL mnpfs3 0 '' 1 'rulebased freeze' .



VALUE LABEL mnpfssdv 1 'not done' 2 'not necessary' 4 'not possible' 8 'deferred' 16 'in progress' 32 'verified' 64 'verified with errors' .VALUE LABEL mnpfsqa 0 '' 1 'with open query' 2 'with answered query' 4 'all queries resolved' .VALUE LABEL mnpfsct 0 '' 1 'with comment' .CACHE.EXECUTE.DATASET NAME atmnpias1bilder1 WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/emnpias1medikament_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpdocid F10.0 mnpsubdocid F10.0 fgid F10.0 position F10.0 wirkstoff A40 dosis F7.2 einnahme A4 .VARIABLE LABELS mnppid 'Patient-ID' mnpdocid'Parent document-ID' mnpsubdocid 'Subdocument-ID' fgid 'Question-ID of Repetition' position 'Position in Repetition' wirkstoff 'Wirkstoff' dosis 'Dosis' einnahme 'Einnahmezeit' .CACHE.EXECUTE.DATASET NAME emnpias1medikament WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/atemnpias1medikament_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnppid F10.0 mnpatdocid F10.0 mnpatsubdocid F10.0 fgid F10.0 position F10.0 wirkstoff A40 dosis F7.2 einnahme A4 .VARIABLE LABELS mnppid 'Patient-ID' mnpatdocid'Parent ATDocument-ID'



mnpatsubdocid 'ATSubdocument-ID' fgid 'Question-ID of Repetition' position 'Position in Repetition' wirkstoff 'Wirkstoff' dosis 'Dosis' einnahme 'Einnahmezeit' .CACHE.EXECUTE.DATASET NAME atemnpias1medikament WINDOW = FRONT .

GET DATA /TYPE = TXT /FILE = 'dat/images_IAS1_20080904-160131.txt' /DELCASE = LINE /DELIMITERS = "," /QUALIFIER = '"' /ARRANGEMENT = DELIMITED /FIRSTCASE = 2 /IMPORTCASE = ALL /VARIABLES = mnpimgid F10.0 uploadedfilename A500 imagesize F22.0 contenttype A40 uploaddate DATETIME23.2 mnpptnid F10.0 originalfile A100 originalstatus A15 webfile A100 webstatus A15 thumbnailfile A100 thumbnailstatus A15 .VARIABLE LABELS mnpimgid 'Image-ID' uploadedfilename 'Uploaded file' imagesize 'Image size (bytes)' contenttype 'Content type' uploaddate 'Date of upload' mnpptnid 'Participant-ID' originalfile 'Original file name' originalstatus 'Status of original file' webfile 'Web file name' webstatus 'Status of web file' thumbnailfile 'Thumbnail file name' thumbnailstatus 'Status of thumbnail file' .VALUE LABEL mnpptnid 1 'Dipl. biol. Susanne Schneider' 151 'Dr. Ulrike Jonas' .CACHE.EXECUTE.DATASET NAME images_ias1 WINDOW = FRONT .

* end of file *



11. Appendix C: CDISC ODM v1.3 example<?xml version="1.0" encoding="Cp1252"?><ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/cmldsig#" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:ias="http://www.secuTrial.de/cdisc/odm/v1.3" xsi:schemaLocation="http://www.secuTrial.de/cdisc/odm/v1.3 ias.xsd" Description="Patients (Valid patients); User Data(yes); AuditTrail(yes); Queries and Comments(yes); Pseudonym(yes); Images (original, web, thumbnail); Hidden Fields(yes); Esignature(yes); Validity(yes); SDV(yes);" FileType="Transactional" FileOID="secuTrial.de/ST30/IAS/IAS1/5_20080904-155925" CreationDateTime="2008-09-04T15:59:25.946+02:00" ODMVersion="1.3" Originator="interActive Systems" SourceSystem="secuTrial" SourceSystemVersion="<dev. version>">

<Study OID="IAS1"><GlobalVariables>

<StudyName>Basisregister</StudyName><StudyDescription/><ProtocolName>IAS1</ProtocolName>

</GlobalVariables><BasicDefinitions/><MetaDataVersion OID="IAS1.0" Name="Basisregister (04.09.2008 - 14:41:34 (CEST))">

<Protocol>

<StudyEventRef StudyEventOID="VISIT.7" OrderNumber="1" Mandatory="Yes"/><StudyEventRef StudyEventOID="VISIT.5" OrderNumber="2" Mandatory="Yes"/><StudyEventRef StudyEventOID="VISIT.3" OrderNumber="3" Mandatory="No"/><StudyEventRef StudyEventOID="VISIT.4" OrderNumber="4" Mandatory="No"/><StudyEventRef StudyEventOID="VISIT.6" OrderNumber="5" Mandatory="No"/><StudyEventRef StudyEventOID="AE" Mandatory="No"/><StudyEventRef StudyEventOID="CN" Mandatory="No"/>

</Protocol><StudyEventDef OID="VISIT.7" Name="1. Visite a" Repeating="No" Type="Scheduled" Category="fixed">

<FormRef FormOID=" F.VMI" Mandatory="Yes"/><FormRef FormOID="F.mnpias1komponenten" OrderNumber="1" Mandatory="No"/><FormRef FormOID="F.mnpias1roentgen" OrderNumber="2" Mandatory="No"/><FormRef FormOID="F.mnpias1score" OrderNumber="3" Mandatory="No"/><FormRef FormOID="F.mnpias1bild" OrderNumber="4" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder1" Mandatory="No"/>

</StudyEventDef><StudyEventDef OID="VISIT.5" Name="2. Visite b" Repeating="No" Type="Scheduled" Category="fixed">

<FormRef FormOID=" F.VMI" Mandatory="Yes"/><FormRef FormOID="F.mnpias1komponenten" OrderNumber="1" Mandatory="No"/><FormRef FormOID="F.mnpias1score" OrderNumber="2" Mandatory="No"/><FormRef FormOID="F.mnpias1bild" OrderNumber="3" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder1" Mandatory="No"/>

</StudyEventDef><StudyEventDef OID="VISIT.3" Name="3. Visite d" Repeating="No" Type="Scheduled" Category="flexible">


</StudyEventDef><StudyEventDef OID="VISIT.4" Name="4. Visite c" Repeating="Yes" Type="Scheduled" Category="fixed">


</StudyEventDef><StudyEventDef OID="VISIT.6" Name="1. Visite e" Repeating="Yes" Type="Common" Category="unscheduled">

<FormRef FormOID=" F.VMI" Mandatory="Yes"/><FormRef FormOID="F.mnpias1komponenten" OrderNumber="1" Mandatory="No"/><FormRef FormOID="F.mnpias1roentgen" OrderNumber="2" Mandatory="No"/><FormRef FormOID="F.mnpias1score" OrderNumber="3" Mandatory="No"/><FormRef FormOID="F.mnpias1bild" OrderNumber="4" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder1" Mandatory="No"/>

</StudyEventDef><StudyEventDef OID="AE" Name="Unerwünschte Ereignisse" Repeating="Yes" Type="Common">

<FormRef FormOID="F.mnpias1ae" OrderNumber="1" Mandatory="No"/><FormRef FormOID="F.mnpias1sae1" OrderNumber="2" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder1" Mandatory="No"/>

</StudyEventDef>



<StudyEventDef OID="CN" Name="Patientenstatus" Repeating="No" Type="Unscheduled"><FormRef FormOID="F.mnpias1status" OrderNumber="1" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder" Mandatory="No"/><FormRef FormOID="F.mnpias1bilder1" Mandatory="No"/>

</StudyEventDef><FormDef OID="F.VMI" Name="General visit information" Repeating="No">

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.VISITDY" Mandatory="Yes"/>

</FormDef><FormDef OID="F.mnpias1komponenten" Name="Basisdaten" Repeating="No">

<Description><TranslatedText xml:lang="en">Dies ist die Formularbeschreibung in <font

color="blue">HTML</font>.</TranslatedText></Description><ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.16" OrderNumber="1" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.8" OrderNumber="3" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.110" OrderNumber="4" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.55" OrderNumber="5" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.9" OrderNumber="7" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.62" OrderNumber="8" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.94" OrderNumber="9" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.96" OrderNumber="11" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.46" OrderNumber="12" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.107" OrderNumber="13" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.54" OrderNumber="14" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.63" OrderNumber="15" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.31" OrderNumber="16" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.97" OrderNumber="17" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.80" OrderNumber="18" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.14" OrderNumber="19" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.86" OrderNumber="20" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.48" OrderNumber="21" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.453" OrderNumber="22" Mandatory="No"/>

</FormDef><FormDef OID="F.mnpias1komponenten1" Name="Komponenten 1" Repeating="No">


color="blue">HTML</font>.</TranslatedText></Description><ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.44" OrderNumber="1" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.113" OrderNumber="3" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.58" OrderNumber="4" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.99" OrderNumber="5" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.100" OrderNumber="7" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.85" OrderNumber="8" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.13" OrderNumber="9" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.4" OrderNumber="11" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.61" OrderNumber="12" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.87" OrderNumber="13" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.116" OrderNumber="14" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.74" OrderNumber="15" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.22" OrderNumber="16" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.33" OrderNumber="17" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.93" OrderNumber="18" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.10" OrderNumber="19" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.450" OrderNumber="20" Mandatory="No"/>

</FormDef><FormDef OID="F.mnpias1roentgen" Name="Röntgenbilder" Repeating="No">

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.71" OrderNumber="1" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.73" OrderNumber="2" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.72" OrderNumber="3" Mandatory="No"/>

</FormDef><FormDef OID="F.mnpias1score" Name="Score-Test" Repeating="No">

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.38" OrderNumber="1" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.39" OrderNumber="2" Mandatory="No"/>

</FormDef><FormDef OID="F.mnpias1bild" Name="Standard-Bild" Repeating="No">

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.434" OrderNumber="1" Mandatory="No"/>



<ItemGroupRef ItemGroupOID="FG.435" OrderNumber="2" Mandatory="No"/></FormDef><FormDef OID="F.mnpias1bild1" Name="Standard-Bild-2" Repeating="No">


</FormDef><FormDef OID="F.mnpias1status" Name="Patientenstatus" Repeating="No">


color="blue">HTML</font>.</TranslatedText></Description><ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.24" OrderNumber="1" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.82" OrderNumber="3" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.47" OrderNumber="4" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.21" OrderNumber="5" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.112" OrderNumber="7" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.60" OrderNumber="8" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.64" OrderNumber="9" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.19" OrderNumber="11" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.5" OrderNumber="12" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.28" OrderNumber="13" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.27" OrderNumber="14" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.30" OrderNumber="15" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.7" OrderNumber="16" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.52" OrderNumber="17" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.45" OrderNumber="18" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.35" OrderNumber="19" Mandatory="No"/>

</FormDef><FormDef OID="F.mnpias1ae" Name="Adverse Event" Repeating="Yes">



</FormDef><FormDef OID="F.mnpias1sae1" Name="Serious Adverse Event" Repeating="Yes">





</FormDef><FormDef OID="F.mnpias1bilder" Name="Bilderformular mit besonders "langem Namen"" Repeating="Yes">


</FormDef><FormDef OID="F.mnpias1bilder1" Name="Röntgen" Repeating="Yes">

<ItemGroupRef ItemGroupOID="FG.SUBJID" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.FS" Mandatory="No"/><ItemGroupRef ItemGroupOID="FG.747" OrderNumber="1" Mandatory="No"/>

</FormDef><ItemGroupDef OID="FG.SUBJID" Name="Patient identifier" Repeating="No">

<ItemRef ItemOID="FF.SUBJID" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.VISITDY" Name="Planned visit date" Repeating="No">

<ItemRef ItemOID="FF.VISITDY" Mandatory="Yes"/></ItemGroupDef><ItemGroupDef OID="FG.FS" Name="Document status information" Repeating="No">

<ItemRef ItemOID="FF.FS.0" Mandatory="No"/><ItemRef ItemOID="FF.FS.1" Mandatory="No"/><ItemRef ItemOID="FF.FS.2" Mandatory="No"/><ItemRef ItemOID="FF.FS.3" Mandatory="No"/><ItemRef ItemOID="FF.FCS.0" Mandatory="No"/><ItemRef ItemOID="FF.FCS.1" Mandatory="No"/><ItemRef ItemOID="FF.FCS.2" Mandatory="No"/><ItemRef ItemOID="FF.FCS.3" Mandatory="No"/><ItemRef ItemOID="FF.FQA" Mandatory="No"/><ItemRef ItemOID="FF.FCT" Mandatory="No"/><ItemRef ItemOID="FF.FSDV" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.16" Name="IASCatalogGroup (Operationen)" Repeating="No">

<ItemRef ItemOID="FF.16.eppc1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.16.epcc2a" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.16.epcc2b" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.16.epcc2c" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.16.epcc2d" OrderNumber="5" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.8" Name="IASCombinedSelection" Repeating="No">

<ItemRef ItemOID="FF.8.tier1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.8.rasse1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.8.farbe1" OrderNumber="3" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.110" Name="IASHorizCombinedSelection" Repeating="No">


</ItemGroupDef><ItemGroupDef OID="FG.55" Name="IASMultipleSelection" Repeating="No">


</ItemGroupDef><ItemGroupDef OID="FG.9" Name="IASHorizRBMatrix" Repeating="No">

<ItemRef ItemOID="FF.9.hb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.9.hb2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.9.hb3" OrderNumber="3" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.62" Name="IASVertRBMatrix" Repeating="No">


</ItemGroupDef><ItemGroupDef OID="FG.94" Name="IASCheckboxMatrix" Repeating="No">

<ItemRef ItemOID="FF.94.r1s1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.94.r1s2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.94.r1s3" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.94.r2s1" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.94.r2s2" OrderNumber="5" Mandatory="No"/><ItemRef ItemOID="FF.94.r2s3" OrderNumber="6" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.96" Name="IASHorizontalGroup" Repeating="No">

<ItemRef ItemOID="FF.96.cb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.96.rb1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.96.rrb1" OrderNumber="3" Mandatory="No"/>


<ItemRef ItemOID="FF.46.cb3" OrderNumber="1" Mandatory="No"/>



<ItemRef ItemOID="FF.46.rrb3" OrderNumber="2" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.107" Name="IASHorizontalUnitGroup" Repeating="No">

<ItemRef ItemOID="FF.107.ugcb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.107.ug" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.107.ugm" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.107.ugt1" OrderNumber="4" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.54" Name="IASUnitGroup" Repeating="No">

<ItemRef ItemOID="FF.54.ugcb2" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.54.ugt2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.54.ug1" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.54.ugm1" OrderNumber="4" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.63" Name="IASStandardGroup" Repeating="No">

<ItemRef ItemOID="FF.63.cb2" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.63.rb2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.63.rrb2" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.63.pp1" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.63.score1" OrderNumber="5" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.31" Name="IASStandardGroup Zahlenfelder - Textfelder" Repeating="No">

<ItemRef ItemOID="FF.31.gz1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.31.kz1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.31.score2" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.31.text1" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.31.text2" OrderNumber="5" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.97" Name="IASStandardGroup Zeitfelder" Repeating="No">

<ItemRef ItemOID="FF.97.zeit1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.97.datum1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.97.zeit2" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.97.datum2" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.97.ddd" OrderNumber="5" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.80" Name="IASStandardGroup - Sonstiges" Repeating="No">

<ItemRef ItemOID="FF.80.random1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.80.hobbies1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.80.haustier1" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.80.abcdefghijabcdefghij" OrderNumber="4" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.14" Name="Bitte geben Sie alle weiteren Medikationen an:" Repeating="Yes">

<ItemRef ItemOID="FF.14.wirkstoff" OrderNumber="1" Mandatory="Yes"/><ItemRef ItemOID="FF.14.dosis" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.14.einnahme" OrderNumber="3" Mandatory="No"/>


<ItemRef ItemOID="FF.86.cb4" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.86.rb3" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.86.rrb4" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.86.pp2" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.86.score3" OrderNumber="5" Mandatory="No"/><ItemRef ItemOID="FF.86.farbe" OrderNumber="6" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.48" Name="IASHorizRBMatrix 2" Repeating="No">


</ItemGroupDef><ItemGroupDef OID="FG.453" Name="Und hier ein paar Bilder" Repeating="No">

<ItemRef ItemOID="FF.453.bild1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.453.bild2" OrderNumber="2" Mandatory="No"/>




















<ItemRef ItemOID="FF.61.cb3" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.61.rrb3" OrderNumber="2" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.87" Name="IASHorizontalUnitGroup" Repeating="No">



<ItemRef ItemOID="FF.116.ugcb2" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.116.ug1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.116.ugm1" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.116.ugt2" OrderNumber="4" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.74" Name="IASStandardGroup: Codelists" Repeating="No">





<ItemRef ItemOID="FF.33.zeit1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.33.datum1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.33.zeit2" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.33.datum2" OrderNumber="4" Mandatory="No"/>


<ItemRef ItemOID="FF.93.random1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.93.hobbies1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.93.haustier1" OrderNumber="3" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.10" Name="Bitte geben Sie alle weiteren Medikationen an:" Repeating="Yes">


</ItemGroupDef><ItemGroupDef OID="FG.450" Name="IASImageGroup" Repeating="No">

<ItemRef ItemOID="FF.450.bild1" OrderNumber="1" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.73" Name="Bildinformationen" Repeating="No">



<ItemRef ItemOID="FF.73.titel" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.73.aufnahme" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.73.beschreibung" OrderNumber="3" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.72" Name="Klinisch auffällig?" Repeating="No">

<ItemRef ItemOID="FF.72.klinisch" OrderNumber="1" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.38" Name="einfache fragen" Repeating="No">

<ItemRef ItemOID="FF.38.sb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.38.vr1" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.38.score" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.38.score2" OrderNumber="4" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.39" Name="rb-matrix" Repeating="No">

<ItemRef ItemOID="FF.39.rb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.39.rb2" OrderNumber="2" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.434" Name="Ein paar ganz normale Fragen" Repeating="No">

<ItemRef ItemOID="FF.434.farbe" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.434.zahl" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.434.wort" OrderNumber="3" Mandatory="No"/>


<ItemRef ItemOID="FF.435.bild1" OrderNumber="1" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.451" Name="Ein paar ganz normale Fragen" Repeating="No">

<ItemRef ItemOID="FF.451.farbe" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.451.zahl" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.451.wort" OrderNumber="3" Mandatory="No"/>


<ItemRef ItemOID="FF.452.bild1" OrderNumber="1" Mandatory="No"/></ItemGroupDef><ItemGroupDef OID="FG.24" Name="IASCatalogGroup (Operationen)" Repeating="No">
































</ItemGroupDef><ItemGroupDef OID="FG.35" Name="IASRepetitionGroup" Repeating="Yes">















<ItemRef ItemOID="FF.81.r1s1" OrderNumber="1" Mandatory="No"/>



<ItemRef ItemOID="FF.81.r1s2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.81.r1s3" OrderNumber="3" Mandatory="No"/><ItemRef ItemOID="FF.81.r2s1" OrderNumber="4" Mandatory="No"/><ItemRef ItemOID="FF.81.r2s2" OrderNumber="5" Mandatory="No"/><ItemRef ItemOID="FF.81.r2s3" OrderNumber="6" Mandatory="No"/>



























</ItemGroupDef>



<ItemGroupDef OID="FG.40" Name="IASHorizRBMatrix" Repeating="No"><ItemRef ItemOID="FF.40.hb1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.40.hb2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.40.hb3" OrderNumber="3" Mandatory="No"/>























</ItemGroupDef><ItemGroupDef OID="FG.385" Name="erstes Bild" Repeating="No">

<ItemRef ItemOID="FF.385.img" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.385.bild2" OrderNumber="2" Mandatory="No"/><ItemRef ItemOID="FF.385.bezeichnung" OrderNumber="3" Mandatory="Yes"/>

</ItemGroupDef><ItemGroupDef OID="FG.431" Name="zweites Bild" Repeating="No" ias:hidden="true">

<ItemRef ItemOID="FF.431.img1" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.431.bild3" OrderNumber="2" Mandatory="No"/>

</ItemGroupDef><ItemGroupDef OID="FG.747" Name="erstes Bild" Repeating="No">



<ItemRef ItemOID="FF.747.img" OrderNumber="1" Mandatory="No"/><ItemRef ItemOID="FF.747.aufnahme" OrderNumber="2" Mandatory="No"/>

</ItemGroupDef><ItemDef OID="FF.SUBJID" Name="Patient identifier" DataType="string" Length="20" SDSVarName="SUBJID"/><ItemDef OID="FF.FS.0" Name="medical review (A)" DataType="integer" Length="2"/><ItemDef OID="FF.FS.1" Name="data review (B)" DataType="integer" Length="2"/><ItemDef OID="FF.FS.2" Name="manual freeze" DataType="integer" Length="2"/><ItemDef OID="FF.FS.3" Name="rulebased freeze" DataType="integer" Length="2"/><ItemDef OID="FF.FCS.0" Name="Completion status" DataType="integer" Length="2">

<CodeListRef CodeListOID="CL.clfcs_0"/></ItemDef><ItemDef OID="FF.FCS.1" Name="Validation status (error)" DataType="integer" Length="2"/><ItemDef OID="FF.FCS.2" Name="Validation status (warning)" DataType="integer" Length="2"/><ItemDef OID="FF.FCS.3" Name="data entry complete" DataType="integer" Length="2"/><ItemDef OID="FF.FQA" Name="Query status" DataType="integer" Length="2">

<CodeListRef CodeListOID="CL.clfqa"/></ItemDef><ItemDef OID="FF.FCT" Name="Comment status" DataType="integer" Length="2"/><ItemDef OID="FF.FSDV" Name="Source Data Verification" DataType="integer" Length="2">

<CodeListRef CodeListOID="CL.clfssdv"/></ItemDef><ItemDef OID="FF.VISITDY" Name="Planned visit date" DataType="date" SDSVarName="VISITDY"/><ItemDef OID="FF.16.eppc1" Name="eppc1" DataType="string" Length="120">

<Question><TranslatedText xml:lang="en">a) Operationsgruppe</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.16.epcc2a" Name="epcc2a" DataType="string" Length="120">

<Question><TranslatedText xml:lang="en">b) Operation</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.16.epcc2b" Name="epcc2b" DataType="string" Length="8">

<Question><TranslatedText xml:lang="en">c) EPCC</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.16.epcc2c" Name="epcc2c" DataType="string" Length="5">

<Question><TranslatedText xml:lang="en">d) ICD-10</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.16.epcc2d" Name="epcc2d" DataType="string" Length="5">

<Question><TranslatedText xml:lang="en">e) ICD-10 additional</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.8.tier1" Name="tier1" DataType="integer" Length="10">

<Question><TranslatedText xml:lang="en">a) Haustier</TranslatedText>

</Question><CodeListRef CodeListOID="CL.lmnpias1tier"/>

</ItemDef><ItemDef OID="FF.8.rasse1" Name="rasse1" DataType="integer" Length="10">

<Question><TranslatedText xml:lang="en">b) Tier-Rasse</TranslatedText>

</Question><CodeListRef CodeListOID="CL.lmnpias1rasse"/>

</ItemDef><ItemDef OID="FF.8.farbe1" Name="farbe1" DataType="integer" Length="10">

<Question><TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText>

</Question><CodeListRef CodeListOID="CL.lmnpias1farbe"/>

</ItemDef><ItemDef OID="FF.110.tier2" Name="tier2" DataType="integer" Length="10">




















</ItemDef><ItemDef OID="FF.9.hb1" Name="hb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">a) Erste Reihe</TranslatedText>

</Question><CodeListRef CodeListOID="CL.9.hb1"/>


<Question><TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText>



<Question><TranslatedText xml:lang="en">c) Dritte Reihe</TranslatedText>











</ItemDef><ItemDef OID="FF.94.r1s1" Name="r1s1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">a) Reihe eins - rot</TranslatedText>

</Question><CodeListRef CodeListOID="CL.clcb"/>


<Question><TranslatedText xml:lang="en">a) Reihe eins - blau</TranslatedText>



<Question><TranslatedText xml:lang="en">a) Reihe eins - grün</TranslatedText>



<Question>



<TranslatedText xml:lang="en">b) Reihe zwei - rot</TranslatedText></Question><CodeListRef CodeListOID="CL.clcb"/>


<Question><TranslatedText xml:lang="en">b) Reihe zwei - blau</TranslatedText>



<Question><TranslatedText xml:lang="en">b) Reihe zwei - grün</TranslatedText>


</ItemDef><ItemDef OID="FF.96.cb1" Name="cb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText>

</Question><CodeListRef CodeListOID="CL.96.cb1"/>

</ItemDef><ItemDef OID="FF.96.rb1" Name="rb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">b) einfacher RadioButton</TranslatedText>

</Question><CodeListRef CodeListOID="CL.96.rb1"/>

</ItemDef><ItemDef OID="FF.96.rrb1" Name="rrb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">c) Reset-Radiobutton</TranslatedText>

</Question><CodeListRef CodeListOID="CL.96.rrb1"/>







</ItemDef><ItemDef OID="FF.107.ugcb1" Name="ugcb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">a) Messung durchgeführt?</TranslatedText>


</ItemDef><ItemDef OID="FF.107.ug" Name="ug" DataType="float" Length="44" SignificantDigits="22">

<Question><TranslatedText xml:lang="en">b) Messwert</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.107.ugm" Name="ugm" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">12. IASHorizontalUnitGroup</TranslatedText>

</Question><CodeListRef CodeListOID="CL.107.ugm"/>

</ItemDef><ItemDef OID="FF.107.ugt1" Name="ugt1" DataType="partialTime">

<Question><TranslatedText xml:lang="en">c) Meßzeitpunkt</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.54.ugcb2" Name="ugcb2" DataType="integer" Length="3">





</Question></ItemDef>



<ItemDef OID="FF.54.ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22"><Question>

<TranslatedText xml:lang="en">b) Messwert</TranslatedText></Question>

</ItemDef><ItemDef OID="FF.54.ugm1" Name="ugm1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">13. IASUnitGroup</TranslatedText>

</Question><CodeListRef CodeListOID="CL.54.ugm1"/>










</ItemDef><ItemDef OID="FF.63.pp1" Name="pp1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">e) Popup</TranslatedText>

</Question><CodeListRef CodeListOID="CL.63.pp1"/>

</ItemDef><ItemDef OID="FF.63.score1" Name="score1" DataType="float" Length="20" SignificantDigits="10">

<Question><TranslatedText xml:lang="en">f) Score über Auswahl-Optionen (Ganzzahlen)</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.31.gz1" Name="gz1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">a) Ganzzahl (3)</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.31.kz1" Name="kz1" DataType="float" Length="8" SignificantDigits="3">

<Question><TranslatedText xml:lang="en">b) Kommazahl (5.3)</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.31.score2" Name="score2" DataType="float" Length="20" SignificantDigits="10">

<Question><TranslatedText xml:lang="en">c) Score über Zahlenfelder</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.31.text1" Name="text1" DataType="string" Length="40">

<Question><TranslatedText xml:lang="en">d) Kurzes Textfeld (40)</TranslatedText>


<Question><TranslatedText xml:lang="en">e) Langes Textfeld (Area, 3x40)</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.97.zeit1" Name="zeit1" DataType="partialTime">

<Question><TranslatedText xml:lang="en">a) Zeitstempel</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.97.datum1" Name="datum1" DataType="partialDate">

<Question><TranslatedText xml:lang="en">b) Datum</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.97.zeit2" Name="zeit2" DataType="incompleteDatetime">

<Question><TranslatedText xml:lang="en">c) geprüfte Zeit</TranslatedText>

</Question>



</ItemDef><ItemDef OID="FF.97.datum2" Name="datum2" DataType="partialDate">

<Question><TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.97.ddd" Name="ddd" DataType="durationDatetime">

<Question><TranslatedText xml:lang="en">16. IASStandardGroup Zeitfelder</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.80.random1" Name="random1" DataType="string" Length="5">

<Question><TranslatedText xml:lang="en">a) Randomization-Button</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.80.hobbies1" Name="hobbies1" DataType="integer" Length="10">

<Question><TranslatedText xml:lang="en">b) Erweiterbare Lookuptabelle</TranslatedText>

</Question><CodeListRef CodeListOID="CL.lmnpias1hobby"/>

</ItemDef><ItemDef OID="FF.80.haustier1" Name="haustier1" DataType="integer" Length="10">

<Question><TranslatedText xml:lang="en">c) einfache Lookuptabelle (Haustier)</TranslatedText>


</ItemDef><ItemDef OID="FF.80.abcdefghijabcdefghij" Name="abcdefghijabcdefghij" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">Namenstest mit Regel</TranslatedText>


</ItemDef><ItemDef OID="FF.14.wirkstoff" Name="wirkstoff" DataType="string" Length="40">

<Question><TranslatedText xml:lang="en">Wirkstoff</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.14.dosis" Name="dosis" DataType="float" Length="5" SignificantDigits="2">

<Question><TranslatedText xml:lang="en">Dosis</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.14.einnahme" Name="einnahme" DataType="partialTime">

<Question><TranslatedText xml:lang="en">Einnahmezeit</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.86.cb4" Name="cb4" DataType="integer" Length="3">














</Question></ItemDef><ItemDef OID="FF.86.farbe" Name="farbe" DataType="integer" Length="3">



<Question><TranslatedText xml:lang="en">Lieblingsfarbe</TranslatedText>

</Question><CodeListRef CodeListOID="CL.86.farbe"/>










</ItemDef><ItemDef OID="FF.453.bild1" Name="bild1" DataType="string" Length="100" ias:hidden="true">

<Question><TranslatedText xml:lang="en">a) Lieblingsbild</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.453.bild2" Name="bild2" DataType="string" Length="100">

<Question><TranslatedText xml:lang="en">b) und noch ein Bild</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.44.eppc1" Name="eppc1" DataType="string" Length="120">






























































</Question>



<CodeListRef CodeListOID="CL.clcb"/></ItemDef><ItemDef OID="FF.13.r1s3" Name="r1s3" DataType="integer" Length="3">




<Question><TranslatedText xml:lang="en">b) Reihe zwei - rot</TranslatedText>






































</ItemDef><ItemDef OID="FF.116.ug1" Name="ug1" DataType="float" Length="44" SignificantDigits="22">


</Question></ItemDef><ItemDef OID="FF.116.ugm1" Name="ugm1" DataType="integer" Length="3">































</Question>



</ItemDef><ItemDef OID="FF.33.datum1" Name="datum1" DataType="partialDate">





















<Question><TranslatedText xml:lang="en">Bild-1</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.73.titel" Name="titel" DataType="string" Length="60">

<Question><TranslatedText xml:lang="en">Titel</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.73.aufnahme" Name="aufnahme" DataType="partialDate">

<Question><TranslatedText xml:lang="en">Aufnahmedatum</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.73.beschreibung" Name="beschreibung" DataType="string" Length="120">

<Question><TranslatedText xml:lang="en">Beschreibung</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.72.klinisch" Name="klinisch" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">Klinisch auffällig?</TranslatedText>

</Question><CodeListRef CodeListOID="CL.72.klinisch"/>

</ItemDef><ItemDef OID="FF.38.sb1" Name="sb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">horizontal radiobutton</TranslatedText>

</Question><CodeListRef CodeListOID="CL.38.sb1"/>



</ItemDef><ItemDef OID="FF.38.vr1" Name="vr1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">vertical radiobutton</TranslatedText>

</Question><CodeListRef CodeListOID="CL.38.vr1"/>

</ItemDef><ItemDef OID="FF.38.score" Name="score" DataType="float" Length="20" SignificantDigits="10">

<Question><TranslatedText xml:lang="en">score berechnen</TranslatedText>


<Question><TranslatedText xml:lang="en">score function</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.39.rb1" Name="rb1" DataType="integer" Length="3">

<Question><TranslatedText xml:lang="en">erste Frage</TranslatedText>



<Question><TranslatedText xml:lang="en">zweite Frage</TranslatedText>


</ItemDef><ItemDef OID="FF.434.farbe" Name="farbe" DataType="integer" Length="3">



</ItemDef><ItemDef OID="FF.434.zahl" Name="zahl" DataType="integer" Length="2">

<Question><TranslatedText xml:lang="en">Lieblingszahl</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.434.wort" Name="wort" DataType="string" Length="60">

<Question><TranslatedText xml:lang="en">Lieblingswort</TranslatedText>


<Question><TranslatedText xml:lang="en">Lieblingsbild</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.451.farbe" Name="farbe" DataType="integer" Length="3">



</ItemDef><ItemDef OID="FF.451.zahl" Name="zahl" DataType="integer" Length="2">

<Question><TranslatedText xml:lang="en">Lieblingszahl</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.451.wort" Name="wort" DataType="string" Length="60">

<Question><TranslatedText xml:lang="en">Lieblingswort</TranslatedText>


<Question><TranslatedText xml:lang="en">Lieblingsbild</TranslatedText>












































<Question>



<TranslatedText xml:lang="en">b) Zweite Reihe</TranslatedText></Question><CodeListRef CodeListOID="CL.112.hb2"/>














































































<Question>



<TranslatedText xml:lang="en">e) Popup</TranslatedText></Question><CodeListRef CodeListOID="CL.30.pp1"/>
















































































































</ItemDef>



<ItemDef OID="FF.95.cb1" Name="cb1" DataType="integer" Length="3"><Question>

<TranslatedText xml:lang="en">a) einfache Checkbox</TranslatedText></Question><CodeListRef CodeListOID="CL.95.cb1"/>













































































































<Question>



<TranslatedText xml:lang="en">c) Tier-Farbe</TranslatedText></Question><CodeListRef CodeListOID="CL.lmnpias1farbe"/>



















































































































</Question></ItemDef>



<ItemDef OID="FF.91.datum2" Name="datum2" DataType="partialDate"><Question>

<TranslatedText xml:lang="en">d) geprüftes Datum</TranslatedText></Question>

</ItemDef><ItemDef OID="FF.66.random1" Name="random1" DataType="string" Length="5">














</Question></ItemDef><ItemDef OID="FF.385.img" Name="img" DataType="string" Length="100">

<Question><TranslatedText xml:lang="en">1) Bild a</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.385.bild2" Name="bild2" DataType="string" Length="100" ias:hidden="true">

<Question><TranslatedText xml:lang="en">2) Bild b</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.385.bezeichnung" Name="bezeichnung" DataType="string" Length="60">

<Question><TranslatedText xml:lang="en">Bezeichnung</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.431.img1" Name="img1" DataType="string" Length="100" ias:hidden="true">

<Question><TranslatedText xml:lang="en">Bild c</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.431.bild3" Name="bild3" DataType="string" Length="100" ias:hidden="true">

<Question><TranslatedText xml:lang="en">Bild d</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.747.img" Name="img" DataType="string" Length="100">

<Question><TranslatedText xml:lang="en">1)</TranslatedText>

</Question></ItemDef><ItemDef OID="FF.747.aufnahme" Name="aufnahme" DataType="string" Length="60">

<Question><TranslatedText xml:lang="en">Aufnahme:</TranslatedText>

</Question></ItemDef><CodeList DataType="integer" OID="CL.100.hb1" Name="hb1">

<CodeListItem CodedValue="2" Rank="1"><Decode>

<TranslatedText xml:lang="en">blau</TranslatedText></Decode>

</CodeListItem>




<TranslatedText xml:lang="en">grün</TranslatedText></Decode>

</CodeListItem><CodeListItem CodedValue="1" Rank="3">

<Decode><TranslatedText xml:lang="en">rot</TranslatedText>

</Decode></CodeListItem>

</CodeList><CodeList DataType="integer" OID="CL.100.hb2" Name="hb2">




<Decode><TranslatedText xml:lang="en">grün</TranslatedText>

</Decode></CodeListItem><CodeListItem CodedValue="1" Rank="3">











</CodeList><CodeList DataType="integer" OID="CL.101.cb2" Name="cb2">

<CodeListItem CodedValue="0"><Decode>

<TranslatedText xml:lang="en">no einheit</TranslatedText></Decode>

</CodeListItem><CodeListItem CodedValue="1">

<Decode><TranslatedText xml:lang="en">yes einheit</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.101.pp1" Name="pp1">








</CodeList><CodeList DataType="integer" OID="CL.101.rb2" Name="rb2">


<TranslatedText xml:lang="en">ja</TranslatedText></Decode>




<Decode><TranslatedText xml:lang="en">nein</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.101.rrb2" Name="rrb2">






</CodeList><CodeList DataType="integer" OID="CL.107.ugm" Name="ugm">


<TranslatedText xml:lang="en">g</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">mol</TranslatedText>




























</CodeList><CodeList DataType="integer" OID="CL.116.ugm1" Name="ugm1">















































































</CodeListItem>




<TranslatedText xml:lang="en">mol</TranslatedText></Decode>

</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.30.cb2" Name="cb2">




















































</CodeList><CodeList DataType="integer" OID="CL.38.sb1" Name="sb1">


<TranslatedText xml:lang="en">eins</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">zwei</TranslatedText>


<Decode><TranslatedText xml:lang="en">drei</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.38.vr1" Name="vr1">


<TranslatedText xml:lang="en">eins</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">zwei</TranslatedText>


<Decode><TranslatedText xml:lang="en">vier</TranslatedText>


<Decode><TranslatedText xml:lang="en">fünf</TranslatedText>












































































</CodeList><CodeList DataType="integer" OID="CL.434.farbe" Name="farbe">



























































































</CodeListItem>




<TranslatedText xml:lang="en">grün</TranslatedText></Decode>




































</CodeList>



<CodeList DataType="integer" OID="CL.61.cb3" Name="cb3"><CodeListItem CodedValue="0">

<Decode><TranslatedText xml:lang="en">no einheit</TranslatedText>

</Decode></CodeListItem><CodeListItem CodedValue="1">



































<TranslatedText xml:lang="en">no einheit</TranslatedText>


































</CodeList><CodeList DataType="integer" OID="CL.72.klinisch" Name="klinisch">






<Decode>



<TranslatedText xml:lang="en">unklar</TranslatedText></Decode>

</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.74.cb2" Name="cb2">





































</Decode>



</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.76.rrb1" Name="rrb1">












































































<Decode>



<TranslatedText xml:lang="en">rot</TranslatedText></Decode>

</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.86.rb3" Name="rb3">













































































<CodeListItem CodedValue="1" Rank="1">



<Decode><TranslatedText xml:lang="en">ja</TranslatedText>










</CodeList><CodeList DataType="integer" OID="CL.SubjectIdentifier" Name="Subject identification">


<TranslatedText xml:lang="en">Pseudonym</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">AID</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.SubjectStatus" Name="Subject status">


<TranslatedText xml:lang="en">active</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">not shown</TranslatedText>


<Decode><TranslatedText xml:lang="en">delete pseudonym</TranslatedText>


<Decode><TranslatedText xml:lang="en">frozen</TranslatedText>


<Decode><TranslatedText xml:lang="en">deceased</TranslatedText>


<Decode><TranslatedText xml:lang="en">to be deleted</TranslatedText>


<Decode><TranslatedText xml:lang="en">visit plan closed</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.SubjectStatusType" Name="Subject type">


<TranslatedText xml:lang="en">subject</TranslatedText></Decode>


<Decode>



<TranslatedText xml:lang="en">subject in study</TranslatedText></Decode>

</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.clcb" Name="CheckBox">


<TranslatedText xml:lang="en">no</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">yes</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.clfcs_0" Name="Completion status">


<TranslatedText xml:lang="en">empty</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">partly filled</TranslatedText>


<Decode><TranslatedText xml:lang="en">completely filled</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.clfqa" Name="Query status">


<TranslatedText xml:lang="en">without query</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">with open query</TranslatedText>


<Decode><TranslatedText xml:lang="en">with answered query</TranslatedText>


<Decode><TranslatedText xml:lang="en">all queries resolved</TranslatedText>


<Decode><TranslatedText xml:lang="en">all queries resolved</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.clfssdv" Name="Source Data Verification">


<TranslatedText xml:lang="en">not done</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">not necessary</TranslatedText>


<Decode><TranslatedText xml:lang="en">not possible</TranslatedText>


<Decode><TranslatedText xml:lang="en">deferred</TranslatedText>




<Decode><TranslatedText xml:lang="en">in progress</TranslatedText>


<Decode><TranslatedText xml:lang="en">verified</TranslatedText>


<Decode><TranslatedText xml:lang="en">verified with errors</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.clqa" Name="type of query entry">


<TranslatedText xml:lang="en"/></Decode>


<Decode><TranslatedText xml:lang="en">open</TranslatedText>


<Decode><TranslatedText xml:lang="en">answered</TranslatedText>


<Decode><TranslatedText xml:lang="en">resolved</TranslatedText>


<Decode><TranslatedText xml:lang="en">check again</TranslatedText>


</CodeList><CodeList DataType="string" OID="CL.clqtype" Name="Query type">

<CodeListItem CodedValue="M"><Decode>

<TranslatedText xml:lang="en">query generated because of a manual check</TranslatedText></Decode>

</CodeListItem><CodeListItem CodedValue="A">

<Decode><TranslatedText xml:lang="en">query generated because of an automatical check

(discrepancy)</TranslatedText></Decode>

</CodeListItem></CodeList><CodeList DataType="integer" OID="CL.lmnpias1farbe" Name="Haustier-Farbe">




<Decode><TranslatedText xml:lang="en">braun</TranslatedText>









<TranslatedText xml:lang="en">braun-schwarz</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">bunt</TranslatedText>


<Decode><TranslatedText xml:lang="en">getigert</TranslatedText>


<Decode><TranslatedText xml:lang="en">Palomino</TranslatedText>


<Decode><TranslatedText xml:lang="en">Rappe</TranslatedText>






<Decode><TranslatedText xml:lang="en">Schimmel</TranslatedText>


<Decode><TranslatedText xml:lang="en">schwarz</TranslatedText>


<Decode><TranslatedText xml:lang="en">schwarz-weiß</TranslatedText>


<Decode><TranslatedText xml:lang="en">tabby</TranslatedText>


<Decode><TranslatedText xml:lang="en">weiß</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.lmnpias1hobby" Name="Hobbies">


<TranslatedText xml:lang="en">Faulenzen</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">Lesen</TranslatedText>


<Decode><TranslatedText xml:lang="en">Sport</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.lmnpias1rasse" Name="Haustier-Rasse">




<TranslatedText xml:lang="en">Araber</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">Dackel</TranslatedText>


<Decode><TranslatedText xml:lang="en">Hannoveraner</TranslatedText>


<Decode><TranslatedText xml:lang="en">Kurzhaar</TranslatedText>


<Decode><TranslatedText xml:lang="en">Perser</TranslatedText>


<Decode><TranslatedText xml:lang="en">Schäferhund</TranslatedText>


<Decode><TranslatedText xml:lang="en">Siam</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.lmnpias1tier" Name="Haustiere">


<TranslatedText xml:lang="en">Hund</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">Katze</TranslatedText>


<Decode><TranslatedText xml:lang="en">Pferd</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.qact" Name="Query or comment">


<TranslatedText xml:lang="en">query entry</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">comment</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.sig" Name="reason for storage">


<TranslatedText xml:lang="en">Data edited</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">Review A performed</TranslatedText>


<Decode><TranslatedText xml:lang="en">Review B performed</TranslatedText>




<Decode><TranslatedText xml:lang="en">Comment added</TranslatedText>


<Decode><TranslatedText xml:lang="en">Query added</TranslatedText>


<Decode><TranslatedText xml:lang="en">Query answered</TranslatedText>


<Decode><TranslatedText xml:lang="en">Form manually frozen</TranslatedText>


<Decode><TranslatedText xml:lang="en">Form unfrozen</TranslatedText>


<Decode><TranslatedText xml:lang="en">Source data verified</TranslatedText>


<Decode><TranslatedText xml:lang="en">Review A revoked</TranslatedText>


<Decode><TranslatedText xml:lang="en">Query resolved</TranslatedText>


<Decode><TranslatedText xml:lang="en">Data entry completed</TranslatedText>


<Decode><TranslatedText xml:lang="en">Data modified</TranslatedText>


<Decode><TranslatedText xml:lang="en">Form frozen</TranslatedText>


</CodeList><CodeList DataType="integer" OID="CL.sigvalid" Name="signature check">


<TranslatedText xml:lang="en">not signed</TranslatedText></Decode>


<Decode><TranslatedText xml:lang="en">valid</TranslatedText>


<Decode><TranslatedText xml:lang="en">invalid</TranslatedText>


</CodeList></MetaDataVersion>

</Study><AdminData>



<User OID="USER.1">

<LoginName>susanne</LoginName><FullName>Dipl. biol. Susanne Schneider</FullName><FirstName>Susanne</FirstName><LastName>Schneider</LastName><LocationRef LocationOID="LOCATION.1"/><LocationRef LocationOID="LOCATION.151"/>

</User><User OID="USER.151">

<LoginName>ulrike</LoginName><FullName>Dr. Ulrike Jonas</FullName><FirstName>Ulrike</FirstName><LastName>Jonas</LastName><LocationRef LocationOID="LOCATION.1"/><LocationRef LocationOID="LOCATION.151"/>

</User><Location OID="LOCATION.1" Name="Berlin" LocationType="Site">

<MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS1.0" EffectiveDate="2008-09-04"/></Location><Location OID="LOCATION.151" Name="Hamburg" LocationType="Site">

<MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS1.0" EffectiveDate="2008-09-04"/></Location><Location OID="LOCATION.172" Name="Zürich" LocationType="Site">

<MetaDataVersionRef StudyOID="IAS1" MetaDataVersionOID="IAS1.0" EffectiveDate="2008-09-04"/></Location><SignatureDef OID="SIG.0" Methodology="Electronic">

<Meaning>Data edited</Meaning><LegalReason>Daten eingegeben</LegalReason>

</SignatureDef></AdminData><ClinicalData StudyOID="IAS1" MetaDataVersionOID="IAS1.0">

<SubjectData SubjectKey="SUBJECT.136" TransactionType="Insert">

<InvestigatorRef UserOID="USER.151"/><SiteRef LocationOID="LOCATION.1"/><Annotation SeqNum="1">

<Comment>active</Comment><Flag>

<FlagValue CodeListOID="CL.SubjectStatus">0</FlagValue><FlagType CodeListOID="CL.SubjectStatusType">0</FlagType>

</Flag></Annotation><Annotation SeqNum="2">

<Comment>active</Comment><Flag>

<FlagValue CodeListOID="CL.SubjectStatus">0</FlagValue><FlagType CodeListOID="CL.SubjectStatusType">1</FlagType>

</Flag></Annotation><Annotation SeqNum="3">

<Comment>edq296</Comment><Flag>

<FlagValue CodeListOID="CL.SubjectIdentifier">0</FlagValue></Flag>

</Annotation><StudyEventData StudyEventOID="VISIT.7" TransactionType="Insert">

<FormData FormOID="F.mnpias1bilder1" FormRepeatKey="mnpdid.199" TransactionType="Insert">

<AuditRecord><UserRef UserOID="USER.1"/><LocationRef LocationOID="LOCATION.1"/><DateTimeStamp>2008-08-18T16:18:21.000+02:00</DateTimeStamp><ReasonForChange>Daten eingegeben</ReasonForChange><SourceID>mnpdid.199</SourceID>

</AuditRecord><Annotation SeqNum="1">

<Comment>Document-No. 199 - 1</Comment></Annotation><Annotation SeqNum="2">

<Comment>Daten eingegeben</Comment><Flag>


</Annotation><Annotation SeqNum="4">

<Comment>not signed</Comment>



<Flag><FlagValue CodeListOID="CL.sigvalid">0</FlagValue>

</Flag></Annotation><ItemGroupData ItemGroupOID="FG.SUBJID">

<ItemDataString ItemOID="FF.SUBJID">edq296</ItemDataString></ItemGroupData><ItemGroupData ItemGroupOID="FG.FS">

<ItemDataInteger ItemOID="FF.FS.0">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FS.1">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FS.2">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FS.3">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FCS.0">4</ItemDataInteger><ItemDataInteger ItemOID="FF.FCS.1">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FCS.2">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FCS.3">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FQA">0</ItemDataInteger><ItemDataInteger ItemOID="FF.FCT">0</ItemDataInteger>

</ItemGroupData><ItemGroupData ItemGroupOID="FG.747">

<ItemDataString ItemOID="FF.747.img" ias:ImageDataID="mnpimgid.147">patientimages/6/36/136/1219069081721-192.168.101.144-7777-1.jpg</ItemDataString>

<ItemDataString ItemOID="FF.747.aufnahme">Ruhepause</ItemDataString></ItemGroupData>

</FormData><FormData FormOID="F.mnpias1bilder1" FormRepeatKey="mnpdid.200" TransactionType="Insert">

<AuditRecord><UserRef UserOID="USER.1"/><LocationRef LocationOID="LOCATION.1"/><DateTimeStamp>2008-08-18T16:18:46.000+02:00</DateTimeStamp><ReasonForChange>Daten eingegeben</ReasonForChange><SourceID>mnpdid.200.mnpatdid.175</SourceID>






<Comment>not signed</Comment><Flag>


</Annotation><ItemGroupData ItemGroupOID="FG.SUBJID">





<ItemDataAny ItemOID="FF.747.aufnahme" IsNull="Yes"/></ItemGroupData>

</FormData><FormData FormOID="F.mnpias1bilder1" FormRepeatKey="mnpdid.200" TransactionType="Update">


</AuditRecord>



<Annotation SeqNum="1"><Comment>Document-No. 200 - 2</Comment>







</Annotation><ItemGroupData ItemGroupOID="FG.FS">




<ItemDataString ItemOID="FF.747.aufnahme">Idylle am Wasser</ItemDataString></ItemGroupData>

</FormData><FormData FormOID="F.mnpias1komponenten" TransactionType="Insert">



<UserRef UserOID="USER.1"/><LocationRef LocationOID="LOCATION.1"/><SignatureRef SignatureOID="SIG.0"/><DateTimeStamp>2008-09-04T14:45:51.000+02:00</DateTimeStamp><ias:Validity>valid</ias:Validity><ias:Version>0</ias:Version>

</Signature><Annotation SeqNum="1">





<Comment>valid</Comment><Flag>







<ItemDataInteger ItemOID="FF.FSDV">1</ItemDataInteger></ItemGroupData><ItemGroupData ItemGroupOID="FG.16">

<ItemDataString ItemOID="FF.16.eppc1">Art der Operation</ItemDataString><ItemDataString ItemOID="FF.16.epcc2a">Operation mit Zugang über den rechten

Ventrikel</ItemDataString><ItemDataString ItemOID="FF.16.epcc2b">12.08.12</ItemDataString><ItemDataAny ItemOID="FF.16.epcc2c" IsNull="Yes"/><ItemDataAny ItemOID="FF.16.epcc2d" IsNull="Yes"/>


<ItemDataInteger ItemOID="FF.8.tier1">2</ItemDataInteger><ItemDataInteger ItemOID="FF.8.rasse1">6</ItemDataInteger><ItemDataInteger ItemOID="FF.8.farbe1">6</ItemDataInteger>






<ItemDataInteger ItemOID="FF.9.hb1">1</ItemDataInteger><ItemDataInteger ItemOID="FF.9.hb2">3</ItemDataInteger><ItemDataInteger ItemOID="FF.9.hb3">2</ItemDataInteger>




<ItemDataInteger ItemOID="FF.94.r1s1">0</ItemDataInteger><ItemDataInteger ItemOID="FF.94.r1s2">1</ItemDataInteger><ItemDataInteger ItemOID="FF.94.r1s3">0</ItemDataInteger><ItemDataInteger ItemOID="FF.94.r2s1">1</ItemDataInteger><ItemDataInteger ItemOID="FF.94.r2s2">0</ItemDataInteger><ItemDataInteger ItemOID="FF.94.r2s3">1</ItemDataInteger>


<ItemDataInteger ItemOID="FF.96.cb1">1</ItemDataInteger><ItemDataInteger ItemOID="FF.96.rb1">0</ItemDataInteger><ItemDataInteger ItemOID="FF.96.rrb1">0</ItemDataInteger>


<ItemDataInteger ItemOID="FF.46.cb3">1</ItemDataInteger><ItemDataInteger ItemOID="FF.46.rrb3">1</ItemDataInteger>


<ItemDataInteger ItemOID="FF.107.ugcb1">0</ItemDataInteger><ItemDataAny ItemOID="FF.107.ug" IsNull="Yes"/><ItemDataAny ItemOID="FF.107.ugm" IsNull="Yes"/><ItemDataAny ItemOID="FF.107.ugt1" IsNull="Yes"/>


<ItemDataInteger ItemOID="FF.54.ugcb2">1</ItemDataInteger><ItemDataPartialTime ItemOID="FF.54.ugt2">14:43</ItemDataPartialTime><ItemDataFloat ItemOID="FF.54.ug1">40.160643</ItemDataFloat><ItemDataInteger ItemOID="FF.54.ugm1">2</ItemDataInteger>


<ItemDataInteger ItemOID="FF.63.cb2">1</ItemDataInteger><ItemDataInteger ItemOID="FF.63.rb2">1</ItemDataInteger><ItemDataInteger ItemOID="FF.63.rrb2">1</ItemDataInteger><ItemDataInteger ItemOID="FF.63.pp1">2</ItemDataInteger><ItemDataFloat ItemOID="FF.63.score1">4.002</ItemDataFloat>


<ItemDataInteger ItemOID="FF.31.gz1">4</ItemDataInteger><ItemDataFloat ItemOID="FF.31.kz1">45.4</ItemDataFloat><ItemDataFloat ItemOID="FF.31.score2">49.4</ItemDataFloat><ItemDataString ItemOID="FF.31.text1">kurz</ItemDataString><ItemDataString ItemOID="FF.31.text2">lange</ItemDataString>




<ItemDataAny ItemOID="FF.97.zeit1" IsNull="Yes"/><ItemDataAny ItemOID="FF.97.datum1" IsNull="Yes"/><ItemDataAny ItemOID="FF.97.zeit2" IsNull="Yes"/><ItemDataAny ItemOID="FF.97.datum2" IsNull="Yes"/><ItemDataAny ItemOID="FF.97.ddd" IsNull="Yes"/>


<ItemDataAny ItemOID="FF.80.random1" IsNull="Yes"/><ItemDataAny ItemOID="FF.80.hobbies1" IsNull="Yes"/><ItemDataAny ItemOID="FF.80.haustier1" IsNull="Yes"/><ItemDataInteger ItemOID="FF.80.abcdefghijabcdefghij">0</ItemDataInteger>

</ItemGroupData><ItemGroupData ItemGroupOID="FG.14" ItemGroupRepeatKey="0">

<ItemDataString ItemOID="FF.14.wirkstoff">wirkstoff 1</ItemDataString><ItemDataFloat ItemOID="FF.14.dosis">1.0</ItemDataFloat><ItemDataPartialTime ItemOID="FF.14.einnahme">11:10</ItemDataPartialTime>


<ItemDataInteger ItemOID="FF.86.cb4">0</ItemDataInteger><ItemDataAny ItemOID="FF.86.rb3" IsNull="Yes"/><ItemDataAny ItemOID="FF.86.rrb4" IsNull="Yes"/><ItemDataAny ItemOID="FF.86.pp2" IsNull="Yes"/><ItemDataFloat ItemOID="FF.86.score3">0.0</ItemDataFloat><ItemDataAny ItemOID="FF.86.farbe" IsNull="Yes"/>




<ItemDataAny ItemOID="FF.453.bild1" IsNull="Yes"/><ItemDataString ItemOID="FF.453.bild2"

ias:ImageDataID="mnpimgid.164">patientimages/6/36/136/1220532265500-192.168.101.144-7777-0.jpg</ItemDataString></ItemGroupData>

</FormData></StudyEventData><StudyEventData StudyEventOID="VISIT.5" TransactionType="Insert"></StudyEventData><StudyEventData StudyEventOID="AE" StudyEventRepeatKey="AE.1.1" TransactionType="Insert">

<FormData FormOID="F.mnpias1ae" FormRepeatKey="AE.1.1.FU.1" TransactionType="Insert">












</ItemGroupData>



<ItemGroupData ItemGroupOID="FG.119"><ItemDataAny ItemOID="FF.119.eppc1" IsNull="Yes"/><ItemDataAny ItemOID="FF.119.epcc2a" IsNull="Yes"/><ItemDataAny ItemOID="FF.119.epcc2b" IsNull="Yes"/><ItemDataAny ItemOID="FF.119.epcc2c" IsNull="Yes"/><ItemDataAny ItemOID="FF.119.epcc2d" IsNull="Yes"/>


<ItemDataAny ItemOID="FF.98.tier1" IsNull="Yes"/><ItemDataAny ItemOID="FF.98.rasse1" IsNull="Yes"/><ItemDataAny ItemOID="FF.98.farbe1" IsNull="Yes"/>






<ItemDataAny ItemOID="FF.59.hb1" IsNull="Yes"/><ItemDataAny ItemOID="FF.59.hb2" IsNull="Yes"/><ItemDataAny ItemOID="FF.59.hb3" IsNull="Yes"/>






<ItemDataInteger ItemOID="FF.95.cb1">0</ItemDataInteger><ItemDataAny ItemOID="FF.95.rb1" IsNull="Yes"/><ItemDataAny ItemOID="FF.95.rrb1" IsNull="Yes"/>


<ItemDataInteger ItemOID="FF.26.cb3">0</ItemDataInteger><ItemDataAny ItemOID="FF.26.rrb3" IsNull="Yes"/>




<ItemDataInteger ItemOID="FF.49.ugcb2">0</ItemDataInteger><ItemDataAny ItemOID="FF.49.ug1" IsNull="Yes"/><ItemDataAny ItemOID="FF.49.ugm1" IsNull="Yes"/><ItemDataAny ItemOID="FF.49.ugt2" IsNull="Yes"/>


<ItemDataInteger ItemOID="FF.101.cb2">0</ItemDataInteger><ItemDataAny ItemOID="FF.101.rb2" IsNull="Yes"/><ItemDataAny ItemOID="FF.101.rrb2" IsNull="Yes"/><ItemDataAny ItemOID="FF.101.pp1" IsNull="Yes"/><ItemDataFloat ItemOID="FF.101.score1">0.0</ItemDataFloat>


<ItemDataAny ItemOID="FF.36.gz1" IsNull="Yes"/><ItemDataAny ItemOID="FF.36.kz1" IsNull="Yes"/><ItemDataAny ItemOID="FF.36.score2" IsNull="Yes"/><ItemDataAny ItemOID="FF.36.text1" IsNull="Yes"/><ItemDataAny ItemOID="FF.36.text2" IsNull="Yes"/>


<ItemDataAny ItemOID="FF.105.zeit1" IsNull="Yes"/><ItemDataAny ItemOID="FF.105.datum1" IsNull="Yes"/><ItemDataAny ItemOID="FF.105.zeit2" IsNull="Yes"/>



<ItemDataAny ItemOID="FF.105.datum2" IsNull="Yes"/></ItemGroupData><ItemGroupData ItemGroupOID="FG.56">

<ItemDataAny ItemOID="FF.56.random1" IsNull="Yes"/><ItemDataAny ItemOID="FF.56.hobbies1" IsNull="Yes"/><ItemDataAny ItemOID="FF.56.haustier1" IsNull="Yes"/>


<ItemDataAny ItemOID="FF.77.wirkstoff" IsNull="Yes"/><ItemDataAny ItemOID="FF.77.dosis" IsNull="Yes"/><ItemDataAny ItemOID="FF.77.einnahme" IsNull="Yes"/>

</ItemGroupData></FormData><FormData FormOID="F.mnpias1bilder1" FormRepeatKey="AE.1.1.FU.1.mnpdid.192" TransactionType="Insert">













<ItemDataString ItemOID="FF.747.img" ias:ImageDataID="mnpimgid.144">patientimages/6/36/136/1219067366214-192.168.101.144-7777-3.JPG</ItemDataString>

<ItemDataString ItemOID="FF.747.aufnahme">Büffet</ItemDataString></ItemGroupData>

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