1. CDISC South African User Group (SAUG) 28-Mar-2012 Co-leaders: Dianne Weatherall, Marielle Knott Presenters: Loryn Thorburn Laurent Marais Wouter van Wyk

2. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

3. 3 Agenda Introductions / Attendance Register Description of Network(s) Background, objectives, membership, organization Charter Discussion Teleconferences/Meetings Next Steps –Presentations –Feedback –Next Meeting Closing

4. 4 Description of Network(s) Background –History of User Networks –CDISC Involvement –CDISC Support

5. 5 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

6. 6 Current Status US User GroupsEuropean User Groups Bay Area Seattle German CDISC User Group Boston Area Atlantic (NY, NJ, PA) Midwest Washington, D.C. Area Research Triangle Park Italian CDISC User Group English CDISC User Group Nordic CDISC User Group French CDISC User Group Delaware Valley

7. 7 Description of Network(s) 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 Encourage non-members to join CDISC

8. 8 Description of Network(s) 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)

9. 9 Description of Network(s) Membership –Open to anyone (CRO or Bio-Pharma) –Regionally oriented for meetings, nation-/world-wide for communications Organization –Coordinator(s) [moderator, minute takers] –Meeting Committee [agenda, materials] –Other(s)?

10. 10 Charter - SAUG Available on portal (under South Africa, approved documents) Objectives Membership and Structure –2 co-leads –Committee members (mainly to plan meetings) –General members (maintained in a membership list) Dues –None (voluntary contributions)

11. Charter - SAUG Policies –CDISC SAUG will remain an open organization, allowing new users to join at any time. –CDISC SAUG will collaborate with CDISC’s Training team for formal training. –CDISC SAUG will be CDISC-aligned and will be registered with CDISC. –CDISC SAUG will follow CDISC ethics Policy & Code of conduct. –CDISC SAUG will be represented in CGUN. Election process 11

12. 12 Charter - SAUG Teleconferences/Meetings –Committee Meetings Monthly –General Meetings F2F vs teleconferences March and September or as deemed necessary –Format Intro/Attendance register 30 mins Presentations 30 mins Q&A 15 mins

13. 13 Teleconferences/Meetings Content –Topics to be submitted 2 months prior to meeting –Include summary of CDISC updates –Initial meeting will be high-level overview material –Future meetings will be more low-level detail

14. 14 Next Steps Presentations –Overview of CDASH (Loryn Thorburn) –10 min break –Overview of SDTM (Laurent Marais) –10 min break –Overview of ADaM (Wouter van Wyk) Sign up for distribution/membership list Feedback (1 month’s time) –Suggested topics for next meeting –Format of meeting Date for September meeting

15. 15 Closing Thank You! Join us again! Contacts: – Liza Faber [Liza.Faber@Quanticate.com] – committee member – Riekert Henning [Riekert.Henning@Quintiles.com] – committee member – Marielle Knott [Marielle.Knott@Quanticate.com] – co-lead – Laurent Marais [Laurent.Marais@Parexel.com] – committee member – Richard Roodman [Richard.Roodman@Parexel.com] – committee member – Wouter van Wyk [Wouter.vanWyk@Quintiles.com] – committee member – Dianne Weatherall [Dianne.Weatherall@Quintiles.com] – co-lead

16. Strength through collaboration. As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards. CDISC operates to advance the continued improvement of public health by enabling efficiencies in medical research and related areas of healthcare.