1. Kopenhagen, 22 April 2008 German CDISC User Group

2. 2 Agenda TimeTopicWho 17:00-17:15WelcomeDR, JH 17:15-17:30German CDISC User group characteristicsDR 17:30-18:15 From SDTM to ADaM and beyond: Practical experience and key learningsJH 18:15-18:45Group discussion All 18:45-19:00German CDISC User group organizationDR, all 19:00-20:00Joint reception with other User Groups All

3. 3 Participants NameCompany Monika KawohlAccovion GmbH Dagmar Kottig-RothAccovion GmbH Arnold EdelbertAccovion GmbH Pia EbhartBAXTER BioScience Nicole BaumgartnerBAXTER BioScience Ingeborg CilBaxter Innovations GmbH Susanne PangritzBayer Healthcare Gisela PottsF. Hoffmann-La Roche Ltd. Daniel RehnF. Hoffmann-La Roche Ltd. Kurt HellsternHands-on GmbH NameCompany Markus StollIBM Global Business Services Elke SennewaldKendle Sabine KiederleKendle Sabine LaukampKendle Johannes HüsingKKS Heidelberg Sebastian Claudius SemlerTMF e.V. Johannes DrepperTMF e.V. Joel HoffmanWaban Software Olga SteinleXClinical GmbH Claus LindenauXClinical GmbH

4. 4 German CDISC User Group Characteristics

5. 5 Participation in CDISC Teams

6. 6 CDISC Models Experts

7. 7 Areas of interest

8. 8 Presentations from Team Members at the CDISC European Interchange

9. 9 CDISC News

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

11. 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. 12 eSubmission of Clinical Content Today SDTM SAS V5 XPT

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

14. 14 A Possible Timeline 14 201020112012201320142015 New Rule Available Mandatory electronic Submission 2016200920082017 Review + Two Years CDISC HL7 Messages Available Two Years ?? Withdrawl of SAS XPT files SAS XPT Mechanism CDISC HL7 Production Message(s) Warning The dates presented on this slide are based upon the author’s knowledge as of January 31 st 2008. They are not official CDISC or FDA policy! CDISC HL7 Development SDTM CONTENT

15. 15 CDISC Case Study

16. 16 CDISC Case Study ProtocolForm Setup & Config Data Capture MappingAnalysisSubmissionReview CDASH Protocol ODM SDTM & ADaM LAB XML First German CDISC User Group Meeting Today

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

18. 18 Group Discussion

19. 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. 20 German CDISC User Group Organization

21. 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. 22 Current German CDISC User Group Portal http://groups.yahoo.com/group/german_cdisc_ug/

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

24. 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. 25 General Introduction into CDISC Models CDISC Interchange CDISC Workshops CDISC training courses CDISC vLearning Course:SDTM Theory & Application Prerequisites: A basic understanding of relational database design is helpful but not required. Brief Description: The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD (electronic Common Technical Document) Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications. This class consists of 1) a detailed review of SDTM concepts, SDTM domain models, and relationship tables, 2) a discussion of common implementation issues, and 3) exercises including CRF-annotations and creation of datasets that reinforce attendees' understanding of the SDTM and the SDTM Implementation Guide. Attendees Will Learn: 1) The theory behind SDTM and the format of data that will be required for submission to the FDA. 2) Key SDTM concepts. 3) How to represent various types of collected data in the SDTM format. Audience:Standards Managers, Data Managers, Statisticians, Programmers, and others involved in the creation or submission of data. This course is also intended for those within regulatory agencies who will use or process data in this format.

26. 26 Q&A

27. 27 Closing remarks

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

29. 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)