Berlin, September 25 th, 2007 German CDISC User Group

2 Herzlich willkommen zum ersten Treffen der deutschsprachigen CDISC User Group!

3 Participants

4 Agenda 10:30Welcome 10:30e3C welcome noteTim Jaeger 10:40Welcome addressAnn-Sofie Bergstrom, Daniel Rehn 10:50Short presentation of TMF, host of the 1st German User Group meeting, and its community working groups Sebastian Semler 11:05CDISC Case Study 11:05Presentation of the TMF ODM to SDTM ConverterJohannes Hüsing, Rolf Meinert, Johannes Drepper 11:50CDISC News 11:50Roadmap Outline: Further development and convergence of SDTM, ODM & Co Jozef Aerts 12:30Lunch and Get-Together 13:30CDISC User Group Discussions / Q&A 13:30Presentation of the CDISC User Group Starter KitDaniel Rehn 14:00Discussion about the future topics, actions and time schedules of the german-speaking CDISC user group Daniel Rehn (Moderator), all 15:00Q&AAll 15:25Closing remarksDaniel Rehn

5 Presentation of the CDISC User Group Starter Kit

6 CDISC User Group Starter Kit Existing contents: First User Group meeting presentation template Bylaws document / Charter –Need working group to complete Step-by-Step Guidance Document –How to proceed to initiate a user group To come: CGUN portal access

7 Description of Network(s) Background –History of User Networks –CDISC Support –User Community Support Current status Organization

8 History of User Networks CDISC User Networks started appearing in the US around 2005 US Networks felt the need to have some common strategy going forward US Networks decided –To hear what Users wanted the Networks to be –To define an Action Plan for the User Networks Detected three major themes from Users –Communication –Education –Organization

9 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

10 Objectives (cont.) 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)

11 Organization Membership –Open to anyone (CRO, Bio-Pharma, others) –Regionally oriented for meetings, nation- /world-wide for communications Organization –Coordinator(s) [moderator, minute takers] –Meeting Committee [agenda, materials] –Other(s)?

12 Organization ByLaws / Charter –Template prepared CGUN Education Committee –Need working group to complete Other Documents –Membership List –CDISC Specialists List –Key Area of Interests List –Minutes/Logs –Presentations

13 Current Status US User GroupsEuropean User Groups Bay Area Seattle German CDISC User Group Boston Area Atlantic (NY, NJ, PA) Chicago Washington, D.C. Area Research Triangle Park Italian CDISC User Group English CDISC User Group Nordic CDISC User Group French CDISC User Group Delaware Area

14 Steps to initiate a User Group Topics 1.Identify need for CDISC Regional User Network in regional area 2.Notify CDISC (Shirley Williams) 3.Create common location to share documents 4.Notify Current Leader of the CDISC Global User Network (Dan Godoy) 5.Notify potential members 6.Prepare for Initial Meeting(s) 7.Elect/Form Executive Committee 8.Author/complete bylaws Status      

15 German CDISC User Group Portal

16 Discussion about the future topics, actions and time schedules of the german CDISC User Group

17 Structure: F2F Meetings Frequency –Once per [interval] Format –Duration = [duration] –Welcome [duration] –CDISC Case Study –CDISC News –CDISC User Group Discussions Workstream presentations [duration] Q&A

18 Structure: Teleconferences Frequency –Once per [interval] Format –Duration = [duration] –Introduction/Roll call [duration] –CDISC News –Workstream(s) presentations [duration] –Q&A

19 Structure: Content Key areas of interest Workstream(s) Content structure –Topics to be submitted [time period] prior to meeting –Workstreams discussions/progress Maximum of [n] per meeting

20 Next Steps Sign up for membership listtoday Sign up for Workstreamstoday Sign up for Expert listtoday Collect key areas of interesttoday Suggest topics for next meeting(s)today Complete Bylaws document asap Approve Bylaws document next meeting Date for next TCtoday Date for next F2F Meetingtoday

21 Q&A

22 Closing remarks

23 Closing remarks Herzlichen Dank! Bis zum nächsten Mal und… weitere Teilnehmer sind immer willkommen! Kontakte: –Daniel Rehn –Ann-Sofie Bergstrom