Basel, 11 March 2010

1. 7th German CDISC User Group Meeting Basel, 11 March 2010

2. 7th German CDISC User Group Meeting Herzlich willkommen in Basel!

3. 7th German CDISC User Group MeetingSome words about „Basler Fasnacht“ • Biggest carnival in Switzerland with 18’000 active participants. The tradition goes back to roman age, current setting since more than 100 years • Starts on the Monday after Ash Wednesday at precisely 4:00 am with the so-called Morgestraich • The carnival lasts for exactly 72 hours and, therefore, ends on Thursday morning at 4:00 am • BaslerFasnacht is often referred to as die dreyscheenschteDääg (the three most beautiful days) • There are two parades taking place on Monday and Wednesday afternoon are called Cortège • The oldest formations are the Cliquen, who march through the old town playing the Piccolo (Pfyffer) and Basler drum (Tamboure). Other formations are called (non-Clique individuals and small groups) and Gugge (marching brass bands), which participants are referred to as Waggis • Schnitzelbank singers are bards singing satirical verses about current events in Basel or from around the world. The verses are sung in Basel German and the singers show Helge (illustrations) to the current verse, also distributed in flyers known as Zeedel

4. 7th German CDISC User Group MeetingAgenda - Morning

5. 7th German CDISC User Group MeetingAgenda - Afternoon

6. Electronic Study ArchivalW. Kuchinke, J. Aerts, S. Semler ODM-based study archival Legal aspects

7. CDISC Open Source and low-cost solutionsJ. Aerts OpenClinica SDTM-ETL OpenCDISC

8. 7th German CDISC User Group MeetingAgenda - Afternoon

9. Define.xml WorkshopM. Kawohl with define.xml workstream members General and technical requirements Define.xml generation Define.xml tools Define.xml validation Outlook (technical, ADaM requirements)

10. CDISC News CDISC Implementation Survey Protocol Representation Model v1.0 CDISC SHARE Pilot Report CDISC Interchange Europe

11. CDISC NewsCDISC Implementation Survey We have conducted a number of surveys over the years in order to understand how the CDISC standards are being adopted and implemented. Your assistance has been invaluable to us and has helped CDISC appreciate the needs of the many communities who now use the standards and those who are planning to use them.We are now asking you to complete a very quick and easy survey considering those same key topics that we have covered in the past. It should take you no longer than 20 minutes to complete.We would be grateful if you could send this survey onto as many relevant people in your organization as possible and thank you for giving up your valuable time to assist CDISC.http://www.surveymonkey.com/s/KXRRPY3 The survey closes on 16 March 2010 at midnight GMT.

12. CDISC NewsCDISC Models – PRM v1.0 Final version of Protocol Representation Model v1.0: • Used for planning and design of a research protocol • Focuses on study characteristics and the definition and association of activities within the protocols, including "arms" and "epochs"  • Defines the roles that participate in those activities • Includes protocol content including Study Design, Eligibility Criteria, and the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries. • Based on the BRIDG Release 3.0 Protocol Representation sub-domain  • Includes all classes in the BRIDG Protocol Representation sub-domain • Includes some classes from other BRIDG sub-domains, generally classes required for ClinicalTrials.gov and the WHO registries

13. CDISC NewsCDISC Models – CDISC SHARE Pilot report for CDISC SHARE: • CDISC Shared Health and Research Electronic Library • CDISC SHARE is a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare • In the first instance, CDISC SHARE will contain the existing CDISC standards, such as CDASH and SDTM, providing machine readable element (variables) within those standards. This will allow a range of applications used within organizations to automatically access those definitions • The pilot report summarizes the observations and findings of the CDISC Share Wiki pilot project and is organized into four sections: Method, Results, Answers to Primary Questions, Other Lessons Learned and Conclusions:http://www.cdisc.org/stuff/contentmgr/files/0/70e1df7a3cd8a66f331770b0bc0f149b/misc/share_pilot_report_1_0.pdf

14. CDISC NewsCDISC Members Only Area

15. Upcoming eventsCDISC Interchange Europe CDISC Interchange Europe 26-30 April 2010 Royal Lancaster Hotel Hyde Park, London, UK Conference 28-29 April 2010 Training 26, 27 & 30 April 2010 Preliminary Program: http://www.cdisc.org/interchange German CDISC User Group Meeting: 27 April 2010, 17:30-19:00, followed by small reception

16. CDISC User Group Discussion Elections: Chair and Executive Committee Work stream concept Topics of interest Next meeting / Meeting locations

17. German CDISC User Group Election of Chair and EC (UG Bylaws) Article 4 – Committees: • Members for the Executive Committee will be elected by the German CDISC User Group participants in a general meeting and by a simple majority and will serve for a term of approximately 2 years. The Executive Committee shall consist of a minimum of 3 people • The Executive Committee will elect a Chair who will serve a term of approximately 2 years by a simple majority. Candidates for the Executive Committee Chair should have an active record of service in the User Group and should usually have served on the Executive Committee. Article 6 – Voting: • All present at a Meeting shall have the right to one vote, except as otherwise specifically provided in the Bylaws. • Decisions will be made by simple majority of the participants present if unanimous consensus cannot be reached. There is, however, an exception for amendments to the Bylaws (see Article 8).

18. German CDISC User GroupElection of Chair and Executive Committee Proposal: • Chair: • Elke Sennewald, Kendle • Executive Committee: • Jozef Aerts, XML4Pharma GmbH • Kurt Hellstern, Hands-On GmbH • Monika Kawohl, Accovion GmbH • Sebastian Claudius Semler, TMF e.V. • TASK: Chair and Executive Committee to be elected by German CDISC User Group to serve a term until (and including) first user group meeting in 2012

19. German CDISC User GroupWorkstream concept • Decision by Executive Committee: Merge of define.xml and ADaM workstreams into eSubmission workstream, led by Monika Kawohl • Open discussion on workstream concept: • Format (F2F, TC)? • Meeting frequency? • Discussion format (trainings, best practices presentations, common implementation of specific topics, etc.)? • What works well, what did not work? • Other workstream requirements • Other modules to be included? • Discontinuation of existing workstreams?

20. German CDISC User GroupTopics of interest • Feedback from UG members (through registration form): • Submission to FDA • Define.xml file • CDASH eCRF - > SDTM implementation experience

21. German CDISC User GroupNext meetings: Dates and locations • 27 April 2010Royal Lancaster Hotel, Hyde Park, London, UK17:30-19:00 • 16. September 2010Parexel GmbH, Berlin (personal communication by Stefan Bordasch)10:00-17:00 • February/March 2011Kendle, Munich, Germany10:00-17:00

22. A last word from the current chair...A big thank you for all your support!!

23. Herzlichen Dank! • Bis zum nächsten Mal und… • weitere Teilnehmer sind immer willkommen! • Kontakte: • Chair/Coordinator: Elke Sennewald (sennewald.elke@kendle.com) • ODM Work stream: Jozef Aerts (jozef.aerts@xml4pharma.com) • SDTM Work stream: Kurt Hellstern (kurt.hellstern@hands-on.ch) • eSubmission Work stream: Monika Kawohl (monika.kawohl@accovion.com) • Organization/Interfaces: Sebastian Semler (sebastian.semler@tmf-ev.de)