1. Budapest, April 21, 2009 5th German CDISC User Group Meeting

2. 2 5th German CDISC User Group Meeting Herzlich willkommen in Budapest!

3. 3 5th German CDISC User Group Meeting Agenda TimeTopicWho 17:00Welcome, CDISC News, Outlook next meetingD. Rehn 17:15Work stream discussionsAll 18:30European User Groups ReceptionAll

4. 4 CDISC News PRM v1.0 available for public comment

5. 5 Protocol Representation Model Development

6. 6 Protocol Representation Model Hierarchy

7. 7 Protocol Representation Model PR Elements Spreadsheet

8. 8 Protocol Representation Model Public review

9. 9 CDISC User Group Organization Next German CDISC User Group Meeting –Location –Date –Suggested topics

10. 10 Next German CDISC User Group Meeting Location, Date, Topics Location: IBM Forum Ehningen, Ehningen (near Stuttgart) Date: Tuesday, 22 September 2009 Suggested topics (apart from workstream discussions): –SDTM 1.2 / SDTM IG 3.1.2 –LOINC/LAB tutorial

11. 11 CDISC User Group Work Streams ODM – J. Aerts SDTM – A. Gromen (today) ADaM / define.xml – E. Sennewald & M. Kawohl

12. 12 CDISC User Group Work Streams Todays participants ODMSDTMADaM/define.xml F. KieferA. GromenB. Traub J. AertsB. WarningE. Sennewald M. StollE. ArnoldM. Kawohl S. Semler (?)J. DrepperM. Knoessl U. LahrJ. WientgesP. Leister W. StoettnerN. SteinU. Ladeck Open E. Mackeracker T. Petrowitsch

13. 13 Herzlichen Dank! Bis zum nächsten Mal und… weitere Teilnehmer sind immer willkommen! Kontakte: Chair/Coordinator:Daniel Rehn (daniel.rehn@roche.com)daniel.rehn@roche.com ODM Work stream: Jozef Aerts (jozef.aerts@xml4pharma.com)jozef.aerts@xml4pharma.com SDTM Work stream:Kurt Hellstern (kurt.hellstern@hands-on.ch)kurt.hellstern@hands-on.ch ADaM Work stream:Elke Sennewald (sennewald.elke@kendle.com)sennewald.elke@kendle.com Define.xml Work stream:Monika Kawohl (monika.kawohl@accovion.com)monika.kawohl@accovion.com Organization/Interfaces:Sebastian Semler (sebastian.semler@tmf-ev.de)sebastian.semler@tmf-ev.de