1. Stuttgart, 22 September 2009 6th German CDISC User Group Meeting

2. 2 6th German CDISC User Group Meeting Herzlich willkommen in Stuttgart (statt Ehningen)!

3. 3 6th German CDISC User Group Meeting Agenda - Morning TimeTopicWho 09:30RegistrationAll 10:00WelcomeD. Rehn, P. Leister 10:15CDISC User Group Work Streams  ODM  SDTM  ADaM  Define.xml Work Stream Leaders, All 12:30Lunch and Get-TogetherAll

4. 4 6th German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho 13:15CDISC Case Studies  SDTM 1.2/SDTM IG 3.1.2 tutorial – 60 min  LOINC tutorial – 60 min SDTM workstream S. Semler, J. Aerts, K. Hellstern 15:15Afternoon BreakAll 15:30CDISC User Group Organization & CDISC News  CDISC European Interchange and public training format discussions  Upcoming CDISC meetings and trainings D. Rehn 16:00CDISC User Group Discussion  Work stream summaries  Topics of interest  Next meeting / Meeting locations  Q&A All 16:30Closing remarksD. Rehn

5. 5 CDISC User Group Work Streams ODM – J. Aerts, XML4Pharma SDTM – K. Hellstern, Hands-On GmbH ADaM – E. Sennewald, Kendle Define.xml – M. Kawohl, Accovion GmbH

6. 6 6th German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho 13:15CDISC Case Studies  SDTM 1.2/SDTM IG 3.1.2 tutorial – 60 min  LOINC tutorial – 60 min SDTM workstream S. Semler, J. Aerts, K. Hellstern 15:15Afternoon BreakAll 15:30CDISC User Group Organization & CDISC News  CDISC European Interchange and public training format discussions  Upcoming CDISC meetings and trainings D. Rehn 16:00CDISC User Group Discussion  Work stream summaries  Topics of interest  Next meeting / Meeting locations  Q&A All 16:30Closing remarksD. Rehn

7. 7 CDISC Case Studies SDTM 1.2/SDTM IG 3.1.2 tutorial – SDTM Workstream Members LOINC tutorial – S. Semler, J. Aerts, K. Hellstern

8. 8 CDISC News CDISC European Interchange meeting and workshop format discussions CDISC SHARE Upcoming CDISC meetings and trainings

9. 9 CDISC Interchange Europe - Meeting Meeting format discussions (1) Aim: To radically re-structure a large piece of the meeting to allow USERS ‘to be heard’ and to generate really rich feedback To enable further development of the models, implementation guides and process so that CDISC can continue to optimize deliverables moving forward with the true users in mind Send out a mail-shot to the users of CDISC standards in Europe, with the following questions: –In your opinion are you more/less efficient / is the business more efficient now compared to ‘before CDISC’? - Elaborate –What currently is causing you difficulties in the implementation of the more mature operational CDISC Models (E.g. SDTM, CDASH, ODM) –What is causing you angst with the less mature, or more visionary, strategic models (PRG, BRIDG, Repository of Shared Semantics/CDISC SHARE) –How easy is it to integrate the CDISC models into your company processes, considering your sourcing strategy and company set-up and infrastructure

10. 10 CDISC Interchange Europe - Meeting Meeting format discussions (2) Process (cont.): Ask users in this communication to hold Cross-functional meetings and discussion within their companies to talk through these areas Ask representatives from these groups or companies come to the 2010 Interchange, prepared to talk through these issues. Set up ‘Model booths’ – SDTM, ADaM, CDASH etc, –Each booth would be chaired by a CDISC team lead / expert – with 3 or 4 helpers (also Subject Matter Experts) – –We don’t want the experts/leads to share, talk or interject – but to LISTEN –Each booth would be open 3 times in an afternoon session (3, one hour slots) and they’d be capped at say 40 people per session (4 tables of 10 in each booth). Issue the chairs with a ‘data capture tool’ that collects comments by table which is then ‘mergable’, and these data are then consolidated into a master set for analysis. The results ultimately will go to the CDISC team leads and CDISC BOD.

11. 11 CDISC Interchange Europe - Workshops Workshop/training course format discussions New type of workshop/training course, dedicated to experienced users of the models There are now a large number of experienced users of the CDISC standards, for whom no consistent and truly global platform to share their experience with the CDISC teams is offered Set up the advanced user focused workshops in the surrounding days, the European Interchange will become more attractive for them. –Host ½ or full day workshops on the most used models. –No long training sessions by the usual instructors –A number of presentations on advanced topics or problems within the models provided by users of the models, interrupted by plenty of discussion in the room. –Participation of at least 1 key member from the relevant team, in order for them to listen to discussions and suggestions and bring the feedback back into the model teams Questions arising from this concept: –Possible advanced topics or problems –Feedback on proposed format –General ideas/suggestions

12. 12 CDISC SHARE Formally known as CMDR or CRSS - Introduction Some sporadic, limited efforts at creating industry standard concepts and variables e.g. the joint NIH/CDISC tuberculosis standard Individual organizations (Pharma, CROs, institutions etc) typically use internal standards (i.e. standards developed within individual organizations) Many intend to move to the use of SDTM and ADaM, but they do not provide a complete set of concepts and variables even for clinical research As a consequence, the ability to aggregate data and to share data is limited as data have to be mapped to alternative standards CDISC SHARE – CDISC Shared Health and Research Electronic Library; CMDR – CDISC Meta Data Repository; CRSS – CDISC Repository of Shared Semantics

13. 13 CDISC SHARE Goal and status Goal: Provide ready access to standards for clinical research and related areas of healthcare via a global, accessible electronic library called SHARE Enable access to precise and standardized data element definitions that can be used in applications and studies to improve data quality and interoperability for biomedical research and its link with healthcare Status: CDISC is presently completing the ‘Inception Phase’ of this project, which entails –Conducting a pilot (Mayo Clinic, GSK, MD Anderson, Eli Lilly and Genzyme) with 50 data elements (variables) in the oncology therapeutic area –Developing a Scope and Vision document that includes risks, benefits and a stakeholder analysis among other sections –The SHARE pilot uses a semantic wiki hosted by Mayo Clinic and the National Cancer Institute

14. 14 CDISC SHARE Webcast CDISC SHARE: Exploring the Collaborative Development of a Global, Shared Electronic Library Date: 6 October 2009 Time: Berlin 14:30 – 16:00 CET Duration: The presentation will last 45 minutes and will be followed by a 15 minute Q&A session Registration: http://www.bettermanagement.com/se minars/seminar.aspx?l=15140 http://www.bettermanagement.com/se minars/seminar.aspx?l=15140 This webinar will include: An introduction, including comments on how SHARE can benefit clinical research, by CDISC Board Chair, Edward Helton, PhD, of the National Cancer Institute An overview of SHARE and early results of the Pilot by CDISC VP, Technical Strategy, Dave Iberson- Hurst Stakeholder Analysis summary by CDISC CEO, Rebecca Kush, PhD Potential business models and the next steps for SHARE by CDISC COO, Frank Newby

15. 15 Upcoming events CDISC Public Training Course CDISC Public Training Course Belgium 28 September – 1 October 2009 Business and Decision Life Sciences Sint Lambertusstraat 141 1200 Brussels ODM implementation (Philippe Verplancke) SDTM Theory & Application (Peter van Reusel) ADaM Theory & Application (Susan Kenny) Registration: http://guest.cvent.com/EVENTS/Info/Summary.aspx?e=2854e199-aab5-4c59- b92a-4163e7a0219a

16. 16 Upcoming events CDISC Interchange North America CDISC Interchange North America 9-13 November 2009 Marriott Baltimore Waterfront Hotel 700 Aliceanna Street Baltimore, MD 21202 Preliminary Program Conference 11-12 November 2009 Training 9, 10 & 13 November 2009

17. 17 Upcoming events CDISC Interchange Europe CDISC Interchange Europe 26-30 April 2010 Royal Lancaster Hotel Hyde Park, London, UK Conference 28-29 April 2010 Training 26, 27 & 30 April 2010

18. 18 CDISC User Group Organization German CDISC User Group Portal Work streams –Summary of today‘s discussion –Setup and going forward

19. 19 German CDISC User Group Portal Overview and topics for today http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/ Topics: Overview Sign in Change password Alerts Surveys Discussions Feedback, room for improvements

20. 20 CDISC User Group Work Streams Summary of today‘s discussions

21. 21 CDISC User Group Work Streams Goals Goals: Sharing of expertise and knowledge Identification of implementation examples Identification of implementation issues New requirements – feedback to CDISC teams Format: F2F Monthly TCs Requirements: Active participation Willingness to contribute Feedback, going forward

22. 22 CDISC User Group Discussion Work stream summaries Topics of interest Next meetings / Meeting locations –Week of 15 February 2010, ??? –27 April 2010, London Q&A

23. 23 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