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Berlin, September 25 th , 2007

German CDISC User Group. Berlin, September 25 th , 2007. Herzlich willkommen zum ersten Treffen der deutschsprachigen CDISC User Group!. Participants. Agenda. Presentation of the CDISC User Group Starter Kit. CDISC User Group Starter Kit. Existing contents:

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Berlin, September 25 th , 2007

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  1. German CDISC User Group Berlin, September 25th, 2007

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

  3. Participants

  4. Agenda

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

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

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

  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 list today • Sign up for Workstreams today • Sign up for Expert list today • Collect key areas of interest today • Suggest topics for next meeting(s) today • Complete Bylaws document asap • Approve Bylaws document next meeting • Date for next TC today • Date for next F2F Meeting today

  21. Q&A

  22. Closing remarks

  23. Closing remarks 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)

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