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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
secuTrial® − web-based data capture in clinical trials − interActive Systems Berlin 2011
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Functional Model
Modules and functions
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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
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DataCapture
Data Entry: Login
Access to all secuTrial tool with login (=User-ID) and password.
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DataCapture
Data Entry: Welcome
The text of the welcome page can be defined in the customer
design properties.
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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!
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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
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DataCapture
Form overview DataCapture
Visit date can be changed as long as no medical data has been
captured.
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DataCapture
Form view
Entry of medical data in different item types (e.g. date fields,
radiobuttons, number fields, selection drop down fields).
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DataCapture
Plausibility checks
Definition in study design per item field.
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DataCapture
Workflow scheme for monitoring
yes
yesyes
no
no
change impossible
change possible
no
Data capturing
Monitoring
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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)
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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)
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DataCapture
Displayed icons
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DataCapture
Easy data capturing
secuTrial® provides an overview of the data capture progress.
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DataCapture
Query asking
Monitor asks query concerning the correctness of data.
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DataCapture
Query treatment
After the Clinical Investigator has answered the query, it can be resolved or
reopened by the monitor.
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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.
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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:”.
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DataCapture
Automatic reply
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DataCapture
Adverse Events
Adverse events can be captured separately from visit plan.
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DataCapture
Adverse and Serious Adverse Events
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DataCapture
The Audit Trail allows you to track all data changes.
Lucid data management
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DataCapture
Lucid data management
Patients according centres over time
Up-to-the-minute overview with vivid statistics, patient overview with
definable properties.
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DataCapture
Lucid data management
Visit status displayed in a report (e.g. completion status
of the forms, queries details, reviews).
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DataCapture
Completion status
Calculation of the sum status per centre/of all centres can be
exported to Excel.
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DataCapture
DDE – Form Overview
Buttons for merging data will only be diplayed if participants have
the corresponding right to see them (AdminTool).
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DataCapture
DDE - Comparison
Both of the data sets can be accessed via the report.
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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
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AdminTool
Role concept
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AdminTool
Creating a new participant (doctors, staffers...)
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AdminTool
Overview: all participants
Data exportable to Excel.
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AdminTool
Creating a new centre
Assignment of participants to the corresponding roles.
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AdminTool
Definition of roles
Definition of roles with corresponding rights.
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AdminTool
Overview: all patients
Editing, deletion, change of centre.
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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
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AdminTool
Resources
Releasing reports, statistics and documents to roles.
Configurate the recipient of messages.
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AdminTool
Choice of colours
Adaptation to the corporate design of a certain product or institute.
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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
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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
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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”
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FormBuilder
Versions in FormBuilder
Projekt
„ZPV3“
pro
du
cti
ve
se
tup
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FormBuilder
Versions in DataCapture
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FormBuilder
Form structureF
orm
Question
Item
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FormBuilder
Form structure
Form numberForm description
Headline
Help text
Unit / Format
Group of labelsItemItem number
Question description
Question textQuestion number
Form name
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FormBuilder
FormBuilder: Form properties
The database table cannot be altered after save.
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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
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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
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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
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FormBuilder
Organising visit families
Forms can be shifted between the individual visit families.
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FormBuilder
Quality assurance of data
Definition of any detailed plausibility checks and
interdependencies.
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FormBuilder
Validation and rules
The general behaviour of the validation can be configured per
form.
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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
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FormBuilder
Check of completion
For immediate validation the error messages will be displayed
directly after opening of an already saved form.
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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
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FormBuilder
Creation of a repetition group
• Create new form of the family type subform
• Create a repetition group in the main form
• Choose subform
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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.
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FormBuilder
Catalogues
Excerpt of cardiovascular diseases from the overall EPCC catalogue
in German. Further hierarchical catalogues importable.
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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
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FormBuilder
Scores
• Calculate scores from (simple arithmetic operations)
• Normed score (mean value)
• Score function (natural logarithm, exponential function, simple
multiplication)
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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
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FormBuilder
Item – Time interval
Calculation of time intervals between comparable date fields.
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FormBuilder
Compare value “item + timespan” for date items
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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
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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 ...
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FormBuilder
Statistics about discrete items
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FormBuilder
Statistics about numeric items
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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.
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FormBuilder
Statistics and reports without administrative centres
Definition in AdminTool as a quality of centres.
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FormBuilder
Convenient study setup
Variable functions including e. g. electronic signature, qualification
tests, patient letters, notifications and a randomization function.
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FormBuilder
Visit plan
Implementation of the study protocol through FormBuilder.
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FormBuilder
Visit plan - texts
Text definition for the creation of a visit plan and visits.
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FormBuilder
Visit plan - types
Definition of names, types and time lag of visits.
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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.
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FormBuilder
Types of visits
• In flexible visits it is mandatory to enter a possible divergence
(time range) in addition to the previewed time.
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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.
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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.
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FormBuilder
Visit plan preview
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FormBuilder
Export / import project setup
Transfer of complete project set-up or selected forms.
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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
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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
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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
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CustomerAdminTool
Editing Customers
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CustomerAdminTool
Background tasks
Automatic background tasks include the generation of
statistics and the bundled message dispatch.
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CustomerAdminTool
Statistic Generation
Statistics are normally generated once a night (configured per
installation). The generation can be started manually too.
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CustomerAdminTool
Database documentation
Documentation can be downloaded for standard schemes,
active customer administrative schemes and project schemes.
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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.
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CustomerAdminTool
Archiving and deletion is only possible if preconditions fulfilled.
Schema Editing
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CustomerAdminTool
Inactivation / Activation
Inactivation affects the setup and productive area of a customer.
Inactive schemes and customer do not connect to the database.
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CustomerAdminTool
Archive is created in the background.
Notification upon finishing per email is possible.
Archive Generation
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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
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CustomerAdminTool
Deletions must be confirmed twice.
Deletion
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CustomerAdminTool
Overview about all finalisation and archive actions.
Archive History
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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
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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
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ExportSearchTool
Scalable export
Exporting data is possible in the following formats:
SAS, SPSS, CDISC-ODM, CSV or TXT.
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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
…
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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
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Variable Label SAS Length SPSS Format
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)
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Variable Label SAS Length SPSS Format
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)
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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
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Variable Label SAS Length SPSS Format
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
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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
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Images
Form overview tab “Image”
The label for the image tab is defined by the name of the
“Image” form family.
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Images
Choice of image form
Image forms are not displayed per default.
They have to be created just as Adverse Event forms.
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Images
Uploading an image
Image items can also be integrated into normal (e.g. visit)
forms.
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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!
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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.
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Images
Display in the AuditTrail
All image changes are reflected in the Audit Trail. Even the former
original images can be download.
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Images
Display of thumbnails in the overview
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Images
Image form report
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Images
Uploading DICOM files
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Images
Executing applet on the local computer
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Images
Choosing images in DICOMDIR
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Images
Process of uploading
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Images
Meaning of symbols for DICOM handling
upload new image
delete image
load DICOM-Viewer
download original as a .zip file
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Images
Preview of images in DICOM viewer
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Images
Detail view of an image in the DICOM viewer
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Images
Anonymisation – DICOM header
Patient Name is replaced by pseudonym, birthday reset to first of
month.
back
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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
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SDV
SDV status and icons
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SDV
SDV handling
Form with SDV popup (opens by click on item SDV icon).
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SDV
SDV handling
Visit-wise completion of SDV. If configured in the project, the
e-signature has to be supplied.
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SDV
Display of SDV status in patient overview
Form and summary display of SDV.
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SDV
Display of SDV status on the report
Icon report with included SDV status.
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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
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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®
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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 '
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DTM
DTM Import
2.
1.
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DTM
Importing discrepancies
Preview of file analysis, the parsing of the file can be adjusted
here.
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DTM
DTM treatment
Creating a query due to a discrepancy.
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DTM
DTM link to query management
“M”anual examination
“A”utomatic examination
Additional
options to close a query
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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:
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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
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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
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Import
Importing patient pseudonyms
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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)
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Import
Importing patients
Preview data analysis, the parsing of the file can be adjusted here.
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Import
Patient import analysis
List of data analysis results in groups.
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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
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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”
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Import
Import format
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Import
Data file format
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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.
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Import
Analysis of the successful result
If necessary for form save, the e-signature has to be entered after
the analysis prior save.
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Import
Analysis of an incorrect result
Data with warnings could be imported by choice.
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Import
Error display
For each error or warning a detail information could be
viewed or downloaded.
back
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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
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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).
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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.
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PRO
Patient login page
The login page for patients includes a link for the semi-
automatically “password lost” process.
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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.
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PRO
Survey of forms for a patient
Icons symbolise study process.
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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.
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PRO
Lost password
Email will be sent automatically to administrator, password link will
then be sent to patient, identification via pseudonym.
back
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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
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SDTM
SDTM variables
Domains Variables
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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