1. CDISC Open Source and low-cost Solutions
Jozef Aerts
XML4Pharma

2. Topics Study design tools OpenClinica EDC
OpenXData for clinical research
CDISC ODM Checker
SDTM generation: SDTM-ETL
Define.xml Checker
OpenCDISC

3. Study Design Tools XML4Pharma ODM Study Designer
Low cost
Single user design tool
Reuse of design libraries
Formedix Origin Study Modeller
Medium cost
Collaboration tool

4. ODM Study Designer

5. ODM Study Designer drag-and-drop

6. ODM Study Designer annotated eCRFs

7. ODM Study Designer annotated CRF as PDF

8. ODM Study Designer annotated CRF as PDF

9. ODM Study Designer complete design as HTML/PDF

10. ODM Study Designer
Supports any Vendor Extension (incl. define.xml) “out of the box”
CDASH forms
SDTM annotation acc. SDTM-IG and
Annotations using “SDSVarName” and “Alias”
Annotated eCRF
Support for upcoming Protocol Extension

11. OpenClinica Open-Source EDC System from Akaza Res.
Very popular among academic institutions and small CROs
ODM 1.3 export
Enterprise version for commercial customers
Validation package
Full support
Most important customer: NCI / caBIG

12. OpenClinica web interface

13. OpenClinica internationalization
Translations (properties files) available for:
French
Spanish
German
Simple Chinese
Italian
Portuguese
Translations are developed by the community

14. OpenClinica and CDISC
Evolution to have CDISC ODM as the base for the architecture
ODM 1.3 export (metadata, clinical data)
Special features as Vendor Extension
In future: SAS XPT export

15. OpenXData Open Source for mobile phone data collection
For primary care and clinical research
System consists of:
Web server
Web form designer
Mobile phones for offline and online data collection
Mobile phone forms based on XForms
Interface developed with OpenClinica
Initiative to generate forms directly from ODM

16. OpenXData Open Source for mobile phone data collection

17. OpenXData Open Source for mobile phone data collection
Enormously successful in developing countries (Pakistan, Ghana, Uganda, ...)
But also interesting for clinical research in developed countries ?

18. CDISC ODM Checker free validation tool
Freely available to CDISC members
New version 1.3
support for ODM 1.2 and 1.3
new GUI
Implements “Include” mechanism for metadata version updates
Reporting facilities

19. CDISC ODM Checker free validation tool

20. CDISC ODM Checker free validation tool

21. SDTM-ETL Transformations from ODM to SDTM
Low-cost (relative to SAS) for developing and execution transformations between operational data (ODM) and submission data (SDTM)
1:1, 1:n and n:1 mappings
Automated generation of (editable) mapping scripts
Many wizards and dialogs
Implements SDTM-IG and 3.1.2
Automated generation of define.xml

22. SDTM-ETL Transformations from ODM to SDTM
Uses XSLT for SDTM records generation
Allows SDTM database generation
Generation of SAS datasets for SDTM
SAS-free
Further development of SDTMWandler
Developed in cooperation with TMV e.V.
Freely available for German institutions and companies

23. SDTM-ETL

24. SDTM-ETL

25. SDTM-ETL New in version 1.4
Partial support for ADaM datasets and other non- SDTM datasets
Mapping completeness reports
Support for non-standard variables => SuppQual
Improved searching and navigation facilities
Extended define.xml views
Incorporation of OpenCDISC for validation

26. Other low-cost (?) mapping tools
XClinical Tabulator
Formedix Submit
Entimo entimICE

27. Define.xml Checker Low-cost validation tool for define.xml files
Validates against the XML-Schema
+ all other rules from the specification
Generation of validation reports (e.g. PDF)

28. Define.xml Checker

29. OpenCDISC Open-source SDTM Validation
Validation of SDTM datasets (SAS XPT) against SDTM and Janus rules
Version 1.0 from OpenCDISC.org
SDTM-IG and 3.1.2
WebSDM rules implementation
Additional user-defined rules validation
define.xml validation
(prototype) define.xml generation
Interfacable with other software

30. OpenCDISC

31. What makes OpenCDISC so interesting ?
Rules are defined as Schematron-XML
Are machine readable
Everyone has the same rules – no different interpretations possible
Opens the door for clear, unambigous rules for SDTM
Now that HL7-XML for SDTM submissions is “dying”, we aim for an SDTM format based on define.xml

32. SDTM datasets proposed formatting “define for data”
SDTM metadata are submitted as define.xml
Why not submit SDTM data as XML using a similar format ?
Advantages:
Rules can be defined and published as Schematron XML
Get rid of all SAS XPT limitations
SUPPQUAL almost becomes unnecessary
Stylesheets for viewing and validation can be developed

33. Thank you -
Herzlichen Dank !