CDISC South African User Group - Enhancing Medical Research and Healthcare

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

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

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

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. 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. 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. 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

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