Interventional and non-interventional clinical trials and ... · Interventional and non-interventional clinical trials and patient registers with. secuTrial® − web-based data capture

interActive Systems Gesellschaft für interaktive Medien mbH Berlin 2011

Interventional and non-interventional clinical trials and patient registers with

secuTrial® − web-based data capture in clinical trials − interActive Systems Berlin 2011

2

Introduction

Introduction to secuTrial®

Training at the Hôpitaux Universitaires de Genève

1th of April 2011


3

Functional Model

Modules and functions


4

DataCapture

DataCapture

• Inclusion of new patients

• Medical data capture in line with the study protocol

• Capturing of adverse events

• Automatic messaging

• Role-specific management of queries and comments

• Up-to-the-minute reports on the status of data capture

• Image management

• Data import

• Reviews and SDV

• Patient reported outcome

• Project documents


5

DataCapture

Data Entry: Login

Access to all secuTrial tool with login (=User-ID) and password.


6

DataCapture

Data Entry: Welcome

The text of the welcome page can be defined in the customer

design properties.


7

DataCapture

Inputting the date of entry

This form will not be stored in the central database and must be

kept carefully. It will be needed for re-identification!


8

DataCapture

Pseudonymisation function

1. Click on “New Patient”, entry date is

entered on centre selection page.

Patient application form is displayed

(+pseudonym).

2. Patient’s master data will be checked

in browser (via Javascript).

3. Click on “Print and create patient”.

Print page will be generated from the

patient’s master data and

pseudonym and send to the printer

(via Javascript).

4. After printing, the form overview of

the patient will be displayed.

Internet

ASP-Server

secuTrial

Datenbank

Browser

1

2

3

4


9

DataCapture

Form overview DataCapture

Visit date can be changed as long as no medical data has been

captured.


10

DataCapture

Form view

Entry of medical data in different item types (e.g. date fields,

radiobuttons, number fields, selection drop down fields).


11

DataCapture

Plausibility checks

Definition in study design per item field.


12

DataCapture

Workflow scheme for monitoring

yes

yesyes

no

no

change impossible

change possible

no

Data capturing

Monitoring


13

DataCapture

Properties

• selectable workflow for monitoring in clinical trials:

separation between data capture and monitoring

• can be enabled customer-wise, configurable project-wise

• additional form status upon termination of data capture

(=DEC)

• subsequent change of data only possible with asked

queries, limited to the query question.

• Additional right to change data with queries

• Separate configuration of e-signature possible

Data Entry Complete (DEC)


14

DataCapture

Displayed icons

1. Data capture by Clinical Investigator (CI), change of data by CI

2. Confirmation of data entry complete by CI (“Save + Data entry

complete”)

3. Query writing in case of faulty items by monitor

4. Change of data for faulty item by CI

5. Query answering by CI

6. Reopening or resolving query by monitor

7. Confirmation of data by monitor after resolving all queries setting

status “Review B”

8. Freezing all forms at the end of data capture by Datamanager

(no more changes possible)


15

DataCapture

Displayed icons


16

DataCapture

Easy data capturing

secuTrial® provides an overview of the data capture progress.


17

DataCapture

Query asking

Monitor asks query concerning the correctness of data.


18

DataCapture

Query treatment

After the Clinical Investigator has answered the query, it can be resolved or

reopened by the monitor.


19

DataCapture

Automatic query answer

• Automatic answering of open queries in case of value

changes to the corresponding query item

• Project-wise configuration in FormBuilder

• Participant must have the right to answer queries

(AdminTool)

• An open query in the form is answered automatically as

soon as the value for which the query has been submitted

is changed. The default answer text is: "Query answered

automatically due to value.”

• If several values with open queries are changed or one

changed item has several open queries, all of those

queries will be answered automatically.


20

DataCapture

Automatic query answer with DEC

• If DEC is activated, open queries exist only after setting the

DEC status

• Only items with queries that have not yet been closed can

be edited.

• To save a form, a reason for the value change must be

specified.

• This reason will be added on the automatic text for query

answering: “Query automatically answered because of

value change with reason:”.


21

DataCapture

Automatic reply


22

DataCapture

Adverse Events

Adverse events can be captured separately from visit plan.


23

DataCapture

Adverse and Serious Adverse Events


24

DataCapture

The Audit Trail allows you to track all data changes.

Lucid data management


25

DataCapture


Patients according centres over time

Up-to-the-minute overview with vivid statistics, patient overview with

definable properties.


26

DataCapture


Visit status displayed in a report (e.g. completion status

of the forms, queries details, reviews).


27

DataCapture

Completion status

Calculation of the sum status per centre/of all centres can be

exported to Excel.


28

DataCapture

DDE – Form Overview

Buttons for merging data will only be diplayed if participants have

the corresponding right to see them (AdminTool).


29

DataCapture

DDE - Comparison

Both of the data sets can be accessed via the report.


30

AdminTool

AdminTool

• Central administration of participants

(handling passwords), centres and

projects

• Definition of rights and roles for

participants and patients (e.g. writing

and reading rights for doctors and

monitors)

• Incremental AuditTrail

• Editing of the specific study design


31

AdminTool

Role concept


32

AdminTool

Creating a new participant (doctors, staffers...)


33

AdminTool

Overview: all participants

Data exportable to Excel.


34

AdminTool

Creating a new centre

Assignment of participants to the corresponding roles.


35

AdminTool

Definition of roles

Definition of roles with corresponding rights.


36

AdminTool

Overview: all patients

Editing, deletion, change of centre.


37

AdminTool

Procedure in the AdminTool

1. Setting up roles

2. Creating new centre

3. Creating new participant

4. Assigning participant to centre (project)

5. Assigning of a role

6. Editing a project- or customer-specific design


38

AdminTool

Resources

Releasing reports, statistics and documents to roles.

Configurate the recipient of messages.


39

AdminTool

Choice of colours

Adaptation to the corporate design of a certain product or institute.


40

FormBuilder

FormBuilder

• Self-sufficient setup of database and study

(automatic generation of database structure

and data model)

• Creation of eCRF (visit plan, form families,

forms, items and help texts)

• Definition of plausibility checks (faulty

formats, interdependencies, limit values,

completion status)

• Definition of additional study parameters

(electronic signature, AuditTrail, documents,

randomisation, qualification test)

• Comprehensive automatic documentation

of database and study setup

• Archiving of changes


41

FormBuilder

Workflow of Study Setup

1. Create customer

2. Create study scheme

3. Create study setup

• Create project

• Configure setup

• Create eCRFs

4. Test setup

5. Change/ deletion /extend setup

6. Release

7. Versioning (FormBuilder)

• Migration into productive

• Archiving

8. Data capturing

9. Change requests

10. Change/ extend/hide setup

11. Test setup

Setup area

Test

Validation

Productive area

Release


42

FormBuilder

Automatic generation of database

while creating forms

Description in “SRTSetup”

Form:

formname formtablename

Untersuchung mnptp0untersuchung

Form

Formgroup:

type fglabel

IASStandardGroup Körperliche Merkmale

IASStandardGroup Aktuelle Verfassung

Question

Formfield:

type fflabel ffcolname

RadioButtonGroup Geschlecht geschlecht

Number 2,0 Alter alterinjahren

Number 1,2 Größe groesse

Time HH:MM:SS Uhrzeit Untersuchung zeit

Item

mnptp0untersuchung:

geschlecht alterinjahren groesse zeit

1 47 1.78 123012

2 38 1.65 081036

1.60

Project data in “TP0”

( WO data model / Database tables) ..........

Formfamily

Project:

Rule

Project:

projectname modelname

Basisregister TP0

Formfamily:

ffamilyname fflevel

Anamnese 1

“FormEngine”


43

FormBuilder

Versions in FormBuilder

Projekt

„ZPV3“

pro

du

cti

ve

se

tup


44

FormBuilder

Versions in DataCapture


45

FormBuilder

Form structureF

orm

Question

Item


46

FormBuilder

Form structure

Form numberForm description

Headline

Help text

Unit / Format

Group of labelsItemItem number

Question description

Question textQuestion number

Form name


47

FormBuilder

FormBuilder: Form properties

The database table cannot be altered after save.


48

FormBuilder

Navigation in FormBuilder

Login Change password

Welcome

DocumentationRelease

Setup Ex- / ImportReports / Statistics

/ LookupsVisit plan

configuraton ProjectCreate / delete / copy

form families

Form preview Form familyCreate / delete / copy

forms

Import mappings Form messages Preconditions Form Create / delete / copyquestions

Qustion Create / delete / copyitems

Labels ItemCreate / delete

rules

Messages RuleCreate / delete

conditions

Condition

neu anlegen

Create project

Catalog listCatalog


49

FormBuilder

Steps to create a new form

1. New form family

2. New form

3. New question

4. New item

5. New rule

6. New condition


50

FormBuilder

Types (Examples)

Form families: Visit, Adverse Event, Casenode, Subform,

Image

Forms: Save, Print, Display, SAE, Test

Questions: IASStandardGroup, IASHorizontalGroup

IASUnitGroups, IASRepetitionGroups

Items: Radio button, Number, Text field

Rules: Limit values, actions, plausibility


51

FormBuilder

Organising visit families

Forms can be shifted between the individual visit families.


52

FormBuilder

Quality assurance of data

Definition of any detailed plausibility checks and

interdependencies.


53

FormBuilder

Validation and rules

The general behaviour of the validation can be configured per

form.


54

FormBuilder

Validation and rules

Mark mandatory (rule based) fields

• Mandatory fields are to be marked with red asterisk

Check of completion

• "Check of completion" contains the specification of whether a value that

is required for the form's completion is still missing.

• "Check of completion" is displayed in addition to error messages due to

item-rule violations.

Immediate validation

• In the case of "Immediate validation” the form is checked for any rule

violations as soon as it is opened and is marked accordingly.

• The check is repeated as soon as you carry out an action on the form

(set query/comment, calculate score, select catalog field)

• Displays all unfulfilled rules


55

FormBuilder

Check of completion

For immediate validation the error messages will be displayed

directly after opening of an already saved form.


56

FormBuilder

(Pre-) Condition and following actions

Conditions

Based on rules or status in preceding form

• Rules: e.g. “Form input not possible, if…”

• Status: completion status, review, freezing

Following actions

• Sending e-mails and / or internal messages


57

FormBuilder

Creation of a repetition group

• Create new form of the family type subform

• Create a repetition group in the main form

• Choose subform


58

FormBuilder

Lookup tables

Simple lookup tables:

Simple option, can be linked in a hierarchy.

• IASMultipleSelection: selection of an entry in one of the lists,

the form is reloaded, and the upper and lower lists are displayed

filtered with adequate contents

• IASCombinedSelection: same function as IASMultipleSelection,

only the first pull-down list is pre-loaded when loading the page

Extendable lookup tables:

Can be extended by the participants.


59

FormBuilder

Catalogues

Excerpt of cardiovascular diseases from the overall EPCC catalogue

in German. Further hierarchical catalogues importable.


60

FormBuilder

Unit groups

• Consists of at least two items, whose types are firmly specified

• Number field and pop-up (group of labels)

• Enables the conversion of units

• Only the reference unit will be saved


61

FormBuilder

Scores

• Calculate scores from (simple arithmetic operations)

• Normed score (mean value)

• Score function (natural logarithm, exponential function, simple

multiplication)


62

FormBuilder

Checkbox matrix

• Creation of items for each single field (different variables)

• Define vertical texts as item texts

• Define horizontal texts as description texts

• Pay attention to the order


63

FormBuilder

Item – Time interval

Calculation of time intervals between comparable date fields.


64

FormBuilder

Compare value “item + timespan” for date items


65

FormBuilder

And / or conjunction rules

Groups of “and”-conjunctions linked with “or”:

- creation of new or-conditions

- creation of new and-conditions in or-group


66

FormBuilder

Configuration of error rules as confirmation

• Input only possible if ...

• Input not possible if ...

• Input required if ...

• Limit value range if ...

• Limit reached if ...


67

FormBuilder

Statistics about discrete items


68

FormBuilder

Statistics about numeric items


69

FormBuilder

Statistics per country and centre

Survey of roles according to the membership of centres to countries.

Statistic per centre is only defined and released once, participant only views statistics of his centre.

Statistic per country is only defined and released once, participant views all statistics of the countries of his centres.

Hint: countries can also be used as areas.


70

FormBuilder

Statistics and reports without administrative centres

Definition in AdminTool as a quality of centres.


71

FormBuilder

Convenient study setup

Variable functions including e. g. electronic signature, qualification

tests, patient letters, notifications and a randomization function.


72

FormBuilder

Visit plan

Implementation of the study protocol through FormBuilder.


73

FormBuilder

Visit plan - texts

Text definition for the creation of a visit plan and visits.


74

FormBuilder

Visit plan - types

Definition of names, types and time lag of visits.


75

FormBuilder

Types of visits

• In fixed visits the visit date is calculated from the prescribed

data.

• The participant is not able to enter a date, the calculation refers

only to the date given in the referenced visit.

• All initial visits of a visit plan must be fixed visits.


76

FormBuilder

Types of visits

• In flexible visits it is mandatory to enter a possible divergence

(time range) in addition to the previewed time.


77

FormBuilder

Types of visits

• In free visits there is no scheduled interval to other visits

and consequently no preceding visit.

• Nevertheless, the visit date can be limited through a time

span which will be compared not to the calculated but the

current date.

• This corresponds to the properties so far in a flexible visit

plan of versions sT 2.2 or earlier.


78

FormBuilder

Types of visits

• Unscheduled visits can be created from the predefined visit

plan.

• They will be skipped when calculating the next planned

visit.

• To use unscheduled visits in alternate treatment plans, you

can enter the time lag to the preceding visit plus an

optional time slot.

• If no indications are given, unscheduled visits can be set

completely freely.


79

FormBuilder

Visit plan preview


80

FormBuilder

Export / import project setup

Transfer of complete project set-up or selected forms.


81

Import

Frequently Asked Questions

I am not able to see the forms - why?

• Allocation in visit plan and rights

I cannot enter the DataCapture - why?

• Allocation to the project

I cannot create new patients - why?

• Existence of at least one centre is obligatory

• No right

• Number of patients is limited

I cannot create a new visit - why?

• Maximum number of visits

• Condition to create a new visit (e.g. completion status)

• Freezed casenode


82

Special Interest Topics

• Image management: create image forms, upload files, DICOM

• Source Data Verification (SDV)

• Discrepancies Transfer Modul (DTM)

• Import:

- Teilnehmer-Import

- Patienten-Import

- Formulardaten-Import

• Patient Reported Outcome (PRO)

• CDISC SDTM Annotations


83

CustomerAdminTool

CustomerAdminTool

• Central administration of the separated customer domains

• 1 customer domain consists of 2x AdminTool, 2x

DataCapture, 2x ExportSearchTool, 1x FormBuilder with

dedicated login URLs

• Creation of administrators (user of AdminTool)

• Creation of (multiple) project database schemes

• Enabling of workflows (SDV, DEC, DTM, DDE, PRO)

• Configuration of additional functions (e.g. „My Account“,

patient file)

• Configuration of general properties like password length,

password change intervals, session timeout

• Background functions (restart of all tools, generate statistics)

• Study finalisation workflow: Inactivation, archiving, deletion

• Documentation of database structures

• Audit trail of configuration changes and study finalisation


84

CustomerAdminTool

Editing Customers


85

CustomerAdminTool

Background tasks

Automatic background tasks include the generation of

statistics and the bundled message dispatch.


86

CustomerAdminTool

Statistic Generation

Statistics are normally generated once a night (configured per

installation). The generation can be started manually too.


87

CustomerAdminTool

Database documentation

Documentation can be downloaded for standard schemes,

active customer administrative schemes and project schemes.


88

CustomerAdminTool

Workflow Study Finalisation

AdminTool:

Database closure: independent in setup and productive area, reversible,

full data insight and export possible

CustomerAdminTool:

Reversible inactivation of project schemes (no data access) or customers

(no login into customer areas)

24 hours after inactivation the archiving of schemes / customers including

participant administration and study setup is possible

If the last made archive is valid, the deletion can be performed after the

next restart of the tool

If the scheme or customer is reactived after archiving, the made archive

will become invalid and a new archive has to be created after the next

inactivation to allow deletion.


89

CustomerAdminTool

Archiving and deletion is only possible if preconditions fulfilled.

Schema Editing


90

CustomerAdminTool

Inactivation / Activation

Inactivation affects the setup and productive area of a customer.

Inactive schemes and customer do not connect to the database.


91

CustomerAdminTool

Archive is created in the background.

Notification upon finishing per email is possible.

Archive Generation


92

CustomerAdminTool

Database Content („data“):

• All patient data (content project schemes)

• Archive scheme: all direct project related data of the participant

administration, archive customer: complete participant administration

• Export data as csv, sql (incl. reinit script), html (=patient files)

Resources („resources“):

• all project / customer related resources (=statistics, exports, download

documents, logos, patient images)

Documentations („documentation“):

• DB documentations of all Schemes

• Configuration files of the installation

• Documentation dossiers and data record files of all project versions

Archive Content


93

CustomerAdminTool

Deletions must be confirmed twice.

Deletion


94

CustomerAdminTool

Overview about all finalisation and archive actions.

Archive History


95

CustomerAdminTool

Icon display of scheme and customer status:

• The customer / the scheme has been created. The scheme

is not been used for a project yet.

• The customer / the scheme has just been activated, the

activation will become valid after the next restart. Or the

scheme is active but the customer is not.

• The customer / the scheme is active.

• The customer / the scheme is inactive.

Status Display


96

ExportSearchTool

ExportSearchTool

• Exporting data from database

• supported formats:

SAS, SPSS, CDISC-ODM, CSV, TXT

• filtering function

• secure data export via TAN

• searching for patients using dynamic

search forms


97

ExportSearchTool

Scalable export

Exporting data is possible in the following formats:

SAS, SPSS, CDISC-ODM, CSV or TXT.


98

ExportSearchTool

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>

ffcolname

mnpqueryid

…

<at-tablename>

mnpdocid <fk>

mnpatdocid <pk>

mnppid <fk>

mnpvisid <fk>

...

(ffcolname)

…comments

mnpdocid <fk>

ffid <fk>

ffcolname

mnpcommentid

…


99

ExportSearchTool

Variable Label SAS Length SPSS Format

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.

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

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

mnpptnid 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.

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 that table.

mnpcs0..7 Case status 0..7 2[clcs_0x.]

F2.0 Status of patient and casenode

visitstartdate Entry date DATE9 EDATE10 Date of patient entry into the project. Base for the calculation of the patients visit plan.

Casenode Table


100

ExportSearchTool


Description

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

mnpdocid Document-ID

10 F10.0 Each eCRF document record has a unique document identifier.

mnplastedit Date of last edit

DATETIME18 DATETIME23.2

Date when record was last edited (=saved).

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.

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.

mnpcvpid Patient visit-ID

10 F10.0 Unique identifier for each patient visit.

mnpvisno Patient 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.

Visit Form Tables (1)


101

ExportSearchTool


Description

mnpfs0..3 Form status (Review / Freeze)

2[clfs_0x.]

F2.0 Status for review sand freeze.

mnpfcs0..3 Form completion status

2[clfs_0x.]

F2.0 Formular completion status, warning and error.

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 been answered.

mnpfsct Form status Comments

2[clct.]

F2.0 A status stating if any comment has been made on this record.

mnpfssdv Form status SDV

2[clfssdv.]

F2.0 A status stating the progress of source data verification.

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 while the signature process.

sigstatus Signature status

$2 Numerical description of the action leading to data storing.

Visit Form Tables (2)


102

ExportSearchTool

Variable Label SAS Length SPSS Format Description

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

mnpaedate Adverse Event date

DATE9 DATETIME23.2 The date when the Adverse Event occurred.

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.

mnpaefuid Adverse Event Follow-up-ID

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

mnpaefudt Adverse Event Follow-up date

DATE9 DATETIME23.2 The date when the patient data was collected for the follow-up.

Adverse Event Tables


103

ExportSearchTool


Description

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

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".

Subform Tables


104

Special Interest Topics

• Image management: create image forms, upload files, DICOM

• Source Data Verification (SDV)

• Discrepancies Transfer Modul (DTM)

• Import:

- Teilnehmer-Import

- Patienten-Import

- Formulardaten-Import

• Patient Reported Outcome (PRO)

• CDISC SDTM Annotations


105

Images

Form overview tab “Image”

The label for the image tab is defined by the name of the

“Image” form family.


106

Images

Choice of image form

Image forms are not displayed per default.

They have to be created just as Adverse Event forms.


107

Images

Uploading an image

Image items can also be integrated into normal (e.g. visit)

forms.


108

Images

Choosing an image file

Every type of file can be uploaded. Only for standard image

files (jpg, png, gif) a thumbnail can be created.

ATTENTION: no check for content is made!


109

Images

Display within the form

Uploaded images are stored as original on the server. For display in the form a preview is created if possible. The preview size is defined in the image item.


110

Images

Display in the AuditTrail

All image changes are reflected in the Audit Trail. Even the former

original images can be download.


111

Images

Display of thumbnails in the overview


112

Images

Image form report


113

Images

Uploading DICOM files


114

Images

Executing applet on the local computer


115

Images

Choosing images in DICOMDIR


116

Images

Process of uploading


117

Images

Meaning of symbols for DICOM handling

upload new image

delete image

load DICOM-Viewer

download original as a .zip file


118

Images

Preview of images in DICOM viewer


119

Images

Detail view of an image in the DICOM viewer


120

Images

Anonymisation – DICOM header

Patient Name is replaced by pseudonym, birthday reset to first of

month.

back


121

SDV

Source Data Verification (SDV)

Properties

• Additional functions for on-site monitoring of clinical trials:

status to compare original with study data

• Releasable per customer, configurable per project

• Separate role right

• Item-specific saving of the SDV status including Audit Trail

• Complete, random and/or summary treatment possible

• Visualisation through additional icons

• Separate configuration of e-signature possible

• Usable with standard or DEC workflow


122

SDV

SDV status and icons


123

SDV

SDV handling

Form with SDV popup (opens by click on item SDV icon).


124

SDV

SDV handling

Visit-wise completion of SDV. If configured in the project, the

e-signature has to be supplied.


125

SDV

Display of SDV status in patient overview

Form and summary display of SDV.


126

SDV

Display of SDV status on the report

Icon report with included SDV status.


127

SDV

Benefits of SDV

• Additional function for on-site monitoring

=> Enlargement of applicability of secuTrial®

=> FDA conform

• Single or summary treatment possible => freedom of choice

concerning the extent of implemented SDV

• Icon symbols for single and summary status

=> quick overview

back


128

DTM

Discrepancies Transfer Module (DTM)

Properties

• Additional function to monitor clinical studies: reintegration of

offline-realized quality control in RDE

• Releasable per customer, configurable per project

• Separate role right

• Import of discrepancy lists (csv or xml format)

• Treatment of discrepancies: rejection or creation of queries

• Link with query management in secuTrial®


129

DTM

DTM csv format

Entry Double Data

Name Check Type Format / Width Explanation

testdcnr - Integer (external) ID of discrepancy

testnr yes Integer (external) ID of test

testdate - Date dd.mm.yyyy Time of test run (MEZ/MESZ)

testtablename yes String 32 Name of affected table

testcolumnname yes String 32 Name of affected column (Item)

testmnpdocid yes Integer ID of affected dataset(= "mnpdid")

testpid yes Integer ID of affected patient

Testtext yes String 1000 Test error message

testinstruction - String 500 Instruction to centre

Example'1';'2';'02.03.2007';'mnpmt1personal';'age';'229';'39';‚age unclear;‚check entry'

'2';'2';'02.03.2007';'mnpmt1personal';'age';'260';'43'; age unclear;' check entry '

'3';'2';'02.03.2007';'mnpmt1personal';'weight';'271';'35'; weigth incorrect;' check entry '


130

DTM

DTM Import

2.

1.


131

DTM

Importing discrepancies

Preview of file analysis, the parsing of the file can be adjusted

here.


132

DTM

DTM treatment

Creating a query due to a discrepancy.


133

DTM

DTM link to query management

“M”anual examination

“A”utomatic examination

Additional

options to close a query


134

DTM

Status of queries and discrepancies

Summed query status is indicated by read symbols in front of

query text, discrepancy status is named by text at the end of

the line display:


135

DTM

Collective queries for discrepancies

For collective query creation select multiple discrepancies per checkbox, edit query content, save queries after locking of forms (not shown):

back


136

Import

Importing participants

Advantage:

• Import prepared participants from set-up area/menu or from

external lists

Note:

• Properties of existing participants (including project and centre

affiliation) will be updated upon importing

• If the newly imported participant already has an existing user-ID,

the existing user-ID will then be extended

• Identifying properties are: surname, name

back


137

Import

Importing patient pseudonyms


138

Import

CSV table format for importing patients

• Pat-ID of imported patient (mandatory)

• Add-ID of imported patient

• Lab-ID of imported patient

• Name of the patient allocated centre. If this does not exist,

it has to be set up.

• User-ID of participant (mandatory)

• Surname of participant (mandatory)

• Name of participant

• Title of participant

• 1st visit date using the format DD.MM.YYYY (mandatory)


139

Import

Importing patients

Preview data analysis, the parsing of the file can be adjusted here.


140

Import

Patient import analysis

List of data analysis results in groups.


141

Import

Visit set-up upon patient import

• No verification of the defined visit plan

• All visit data information, each enclosed in

"{Visitenlabel:01.03.2000}{1:1.Visit:02.03.2000 }{04.05.2004 } "

in a separate column

• Identification by visit label possible

• Identification by visit number and visit label possible (if label

include visit number)

• If only date is supplied only planed visits are taken into account

• For unplanned visits the visit label must be given

back


142

Import

Form mass import / characteristics:

• Medical data import of multiple patients into separate forms

• Data analysis (form mistakes, access authorisation)

• Verification of patient status (frozen or deceased)

• Verification of form preconditions

• Performs an e-signature (if set up)

• Saving of forms and operation of subsequent actions as usual

(e.g. freeze)

• Error analysis

• Form mass import displayed as “Data imported”


143

Import

Import format


144

Import

Data file format


145

Import

DataCapture options (preview)

After selecting the form and visit for import and upload the import

file the preview allows the adjusting of file parsing.


146

Import

Analysis of the successful result

If necessary for form save, the e-signature has to be entered after

the analysis prior save.


147

Import

Analysis of an incorrect result

Data with warnings could be imported by choice.


148

Import

Error display

For each error or warning a detail information could be

viewed or downloaded.

back


149

PRO

Patient Reported Outcome (PRO)

• PRO configuration per customer within

CustomerAdminTool

• PRO configuration per project within FormBuilder

• Set up patient roles and manage patient access within

AdminTool and also DataCapture

• Definition of separate patient texts (e.g. welcome page)

• Hide footer and Audit Trail button to simplify eCRF


150

PRO

Admission of patients managed by physician

Physician adds patient and links the secuTrial pseudonym

with a patient role. The patient can be informed via email

(mail address not stored in system).


151

PRO

(Email) notification of patient login data

Login data and password link will be sent in separate emails

or can be displayed as a print view.


152

PRO

Patient login page

The login page for patients includes a link for the semi-

automatically “password lost” process.


153

PRO

Patient welcome page

The patients have a separate welcome page that can contain

download documents. The “Data Entry” button leads to the form

overview.


154

PRO

Survey of forms for a patient

Icons symbolise study process.


155

PRO

eCRF display for patients

A patient can enter his/her own data, the access is regulated by the patient’s role. The display of the eCRF is simplified by omitting the Audit Trail button and the status footer.


156

PRO

Lost password

Email will be sent automatically to administrator, password link will

then be sent to patient, identification via pseudonym.

back


157

SDTM

SDTM variables

Selection or free input of SDTM domains for questions,

selection or free input of SDTM variables as SDSVarName for

items, specification of additional alias for questions and items.

Question

Item


158

SDTM

SDTM variables

Domains Variables


159

SDTM

SDTM variables

Defined SDTM variables are displayed in the CDISC export as

ODM annotations, the defined “Alias” are added as additional

elements.

Question

Item

back

Documents

Interventional and non-interventional clinical trials and ... · Interventional and non-interventional clinical trials and patient registers with. secuTrial® − web-based data capture