Kopenhagen, 22 April 2008

1. German CDISC User Group Kopenhagen, 22 April 2008

2. Agenda

3. Participants

4. German CDISC User Group Characteristics

5. Participation in CDISC Teams

6. CDISC Models Experts

7. Areas of interest

8. Presentations from Team Members at the CDISC European Interchange

9. CDISC News

10. FDA’s Draft PDUFA IV 5-Year IT Plan 10

11. FDA’s Draft PDUFA IV 5-Year IT Plan The foundation for the standardized clinical content is the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). The SDTM will also include nonclinical requirements based on the Standard for Exchange of Nonclinical Data (SEND) models that is being harmonized with the SDTM. The CDISC content will be sent to FDA as an XML message using the Health Level Seven (HL7) Reference Information Model (RIM) and harmonized with the Biomedical Research Integrated Domain Group (BRIDG) Model. SDTM version 3.1.1 submissions are accepted by FDA. A draft implementation guide for SDTM 3.1.2 is currently under review by CDISC and FDA. FDA and CDISC are in the process of forming a communications team that will ensure SDTM meets FDA’s scientific requirements. Source: Draft PDUFA IV Plan, December 2007, Page 23

12. eSubmission of Clinical Content Today SDTM SAS V5 XPT

13. eSubmission of Clinical Conent Tomorrow Metadata SDTM Derived (ADaM) SAP ? + + + In Development HL7 V3 Message(s)

14. A Possible Timeline 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Review + Two Years Two Years ?? New Rule Available Mandatory electronic Submission CDISC HL7 Messages Available Withdrawl of SAS XPT files SDTM CONTENT SAS XPT Mechanism CDISC HL7 Development CDISC HL7 Production Message(s) Warning The dates presented on this slide are based upon the author’s knowledge as of January 31st 2008. They are not official CDISC or FDA policy! 14

15. CDISC Case Study

16. First German CDISC User Group Meeting Today CDISC Case Study Protocol Form Setup & Config Data Capture Mapping Analysis Submission Review Protocol CDASH SDTM & ADaM ODM LAB XML

17. CDISC Case Study From SDTM to ADaM and beyond: Practical experience and key learnings Joel Hoffman, Waban Software

18. Group Discussion

19. Group Discussion More information: • European CDISC Interchange: • CDISC Website (Members only area): • Pilot project report • Pilot Project Submission Package • Metadata Tools used in the Pilot Project

20. German CDISC User Group Organization

21. User Group Objectives • Support CDISC • Test models • Propose implementation approaches • Propose new domains • Provide a network to address domain specific issues • Promote/distribute standards • Support CDISC activities • Support User Community • Provide more direct links to CDISC Organization • Contact Network • Discussion Forum • Expansion of community (i.e., other Networks) • More involvement • Support for implementation • Documentation of issues/resolutions • Access to documentation (regardless of implementation level at individual company)

22. Current German CDISC User Group Portal http://groups.yahoo.com/group/german_cdisc_ug/

23. Future German CDISC User Group Portal http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

24. Contact Network • German CDISC User Group Portal • News / Announcements • Shared documents • Discussions • Surveys • Member lists with profiles • German CDISC User Group Meetings • Working Groups • Case Studies and Best Practices • CDISC News

25. General Introduction into CDISC Models • CDISC Interchange • CDISC Workshops • CDISC training courses • CDISC vLearning

26. Q&A

27. Closing remarks

28. Next Meeting • Early September 2008 • Basel • CDISC News • CDISC Case Study • Group Discussion • User Group Steering Team • Working Groups

29. Herzlichen Dank! Bis zum nächsten Mal und… weitere Teilnehmer sind immer willkommen! • Kontakte: • Daniel Rehn (daniel.rehn@roche.com) • Ann-Sofie Bergstrom (ann-sofie.bergstrom@swe.sas.com)