1. Basel, September 2, 2008 3rd German CDISC User Group Meeting

2. 2 3rd German CDISC User Group Meeting Herzlich willkommen in Basel!

3. 3 3rd German CDISC User Group Meeting Some words about Basel Third most populous city with 166,209 inhabitants (2008) 731,000 inhabitants in the metropolitan area Oldest university of the Swiss Confederation (1460) Basel was called "Basilia" in Latin, and this name is documented from the year 374 AD In 1225–1226 the Bridge over the Rhine was constructed lesser Basel (Kleinbasel) founded as a beachhead to protect the bridge In 1356 the Basel earthquake destroyed much of the city In 1501 Basel joined the Swiss Confederation as 11th canton

4. F. Hoffmann-La Roche AG Shaped by family values for over 110 years Adele and Fritz Hoffmann-La Roche

5. Roche Basel then … 1896 1945

6. Roche Basel today … and tomorrow

7. Roche Group Structure Diagnostics Roche Diabetes Care Roche Applied Science Pharmaceuticals Roche Pharma ChugaiGenentechRoche Professional Diagnostics Roche Molecular Diagnostics Ventana Medical Systems

8. Basel headquarters One of Roches largest centers Group and divisional management, Corporate Executive Committee functions Global management of R&D, production and marketing More than 7,500 employees Pharma research: metabolic disorders, diseases of the central nervous system Pharma production: around 20 medicines are manufactured in Basel Pharma packaging and logistics centre in Kaiseraugst

9. 9 3rd German CDISC User Group Meeting Agenda - Morning TimeTopicWho 9:30RegistrationAll 10:00WelcomeD. Rehn 10:15German CDISC User Group OrganizationD. Rehn 11:15CDISC News General news BRIDG ADaM D. Rehn M. Regenass E. Sennewald 12:15Lunch and Get-TogetherAll

10. 10 3rd German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho 13:00CDISC Case Studies ODM-based CRF print-outs and SAS export CDISC-based eSubmission M. Walter M. Kawohl 14:00CDISC User Group work streams ODM SDTM ADaM Define.xml Work stream leaders, All 15:30Afternoon BreakAll 15:45CDISC User Group Discussion Work stream summaries Best practices Topics of interest Next meeting / Meeting locations Q&A All 16:45Closing remarksD. Rehn

11. 11 CDISC User Group Organization Bylaws Chair and Executive Committee Work Streams Update on CDISC User Group Portals Updates from Other CDISC User Groups

12. 12 Global CDISC User Network General 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 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)

13. 13 Bylaws Definition Bylaw is a rule governing the internal management of an organization, such as a business corporation. In a business situation, bylaws are drafted under the authority of its Charter or Articles of Incorporation. The bylaws contain the most fundamental principles and rules regarding the nature of the organization. They widely vary from organization to organization, but generally cover topics such as how directors are elected, how meetings of directors (and in the case of a business, shareholders) are conducted, and what officers the organization will have and a description of their duties. Unless otherwise provided by law, the organization does not formally exist until bylaws have been adopted. CDISC Global User Network (CGUN) CDISC Regional User Network 1 (CRUN 1) CDISC Regional User Network 2 (CRUN 2) CDISC Regional User Network 3 (CRUN 3) Charter Bylaws 1Bylaws 2Bylaws 3

14. 14 German CDISC User Group Bylaws Article 1 - Name The name of the organization shall be the German CDISC User Group, hereto after referred to as the User Group.

15. 15 German CDISC User Group Bylaws Article 2 – Purpose and Objectives Purpose - The User Group is an independent, grassroots community of CDISC Users, committed to the open exchange of knowledge and information on the implementation of CDISC standards with local users from german-speaking European countries. Other interested parties are welcome to participate as well. Objectives – The objectives of the User Group are to: a)Provide a venue for presentations and discussions about the CDISC standards b)Provide a forum for participants to share knowledge and cooperatively address CDISC standards implementation issues c)Elevate the level of familiarity of CDISC among participants and within participating organizations d)Act as a liaison to the national and regional CDISC organizations e)Provide a cooperative voice for pharmaceutical and biotechnology companies, universities and institutions, and service providers from german-speaking European countries for discussion of standards and related regulations

16. 16 German CDISC User Group Bylaws Article 3 – Membership Participation in the User Group shall be open to all who share in its purpose.

17. 17 German CDISC User Group Bylaws Article 4 – Committees Members for the Executive Committee will be elected by the German CDISC User Group participants in a general meeting and by a simple majority and will serve for a term of approximately 2 years. The Executive Committee shall consist of a minimum of 3 people. The Executive Committee shall manage the business of the User Group. The Executive Committee may eliminate committees and may establish new committees as necessary to carry out the objectives of the User Group. The responsibilities of the Executive Committee are; a)Plan and run general meetings b)Communicate with membership c)Communicate with CDISC and other organizations d)Maintain Bylaws document e)Form and/or participate on subcommittees or work streams f)Any other business of the User Group as required

18. 18 German CDISC User Group Bylaws Article 4 – Committees (cont.) The Executive Committee will elect a Chair who will serve a term of approximately 2 years by a simple majority. Candidates for the Executive Committee Chair should have an active record of service in the User Group and should usually have served on the Executive Committee. The Executive Committee may charter permanent or ad hoc committees or work streams as necessary to carry out the objectives of the User Group. The Executive Committee will solicit participation on these committees or work streams from the general membership. An Executive Committee member will lead each committee or work stream. The Executive Committee and other committees or work streams shall generally make decisions regarding User Group business based on consensus. In the event that a committee or work stream chooses to take a vote on a matter, all present at the meeting shall have the right to one vote and decisions will be made by a simple majority.

19. 19 German CDISC User Group Bylaws Article 5 – Meetings Executive Committee Meetings – Teleconferences shall be held on a bi- monthly basis, or as deemed necessary by the Executive Committee. Members shall be notified of the time and place of the Meeting with 7 day minimum notice. General User Group Meetings – approximately two to three meetings shall be held over the course of each year at a place and time determined by the Executive Committee or its designee. Members shall be notified of the time and place of the Meeting with 3 months minimum notice and a draft agenda shall be submitted with 28 day minimum notice. Other committees or work streams shall meet as deemed necessary. All meetings and teleconferences of the User Group shall be open to all.

20. 20 German CDISC User Group Bylaws Article 6 – Voting All present at a Meeting shall have the right to one vote, except as otherwise specifically provided in the Bylaws. Decisions will be made by simple majority of the participants present if unanimous consensus cannot be reached. There is, however, an exception for amendments to the Bylaws (see Article 8).

21. 21 German CDISC User Group Bylaws Article 7 – Dues The User Group shall not charge dues for membership. Voluntary contributions such as providing meeting facilities, teleconference services, or refreshments are welcomed.

22. 22 German CDISC User Group Bylaws Article 8 – Amendments Amendments to the Bylaws may be proposed by any participant of the User Group. The Bylaws must be amended by at least ten participants and constituting two-thirds affirmative vote of those present. Notice of proposed changes to the Bylaws must be announced by the Executive Committee to the General Membership at least 28 days prior to each vote. Amended Bylaws will be effective immediately upon approval, unless otherwise requested in the proposed change or recommended by the Executive Committee.

23. 23 German CDISC User Group Bylaws Article 9 – Dissolution Dissolution of the User Group will occur by a general meeting and has to be agreed by a two-thirds affirmative vote of those present. TASK: Bylaws to be agreed by German CDISC User Group

24. 24 German CDISC User Group Election of Chair and Executive Committee Proposal: Chair: –Daniel Rehn, F. Hoffmann-La Roche AG Executive Committee: –Jozef Aerts, XML4Pharma GmbH –Kurt Hellstern, Hands-On GmbH –Monika Kawohl, Accovion GmbH –Elke Sennewald, Kendle –Sebastian Claudius Semler, TMF e.V. TASK: Chair and Executive Committee to be elected by German CDISC User Group to serve a term until (and including) first user group meeting in 2010

25. 25 German CDISC User Group Establishment of Work Streams Proposed work streams: ODM, led by Jozef Aerts, XML4Pharma GmbH SDTM (incl. CDASH and controlled terminology), led by Kurt Hellstern, Hands-On GmbH ADaM, led by Elke Sennewald, Kendle define.xml / eSubmission, led by Monika Kawohl, Accovion GmbH Work stream tasks: Information exchange Best practices (discuss, prepare, present) Implementation issues Requests for new requirements Discussion of work stream goals and meeting schedule (TCs) TASK: Proposed work streams to be agreed by German CDISC User Group

26. 26 German CDISC User Group Portal Current http://groups.yahoo.com/group/german_cdisc_ug/

27. 27 German CDISC User Group Portal Future http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

28. 28 Regional CDISC User Groups Contact Network Regional CDISC User Group Portals –News / Announcements –Shared documents –Discussions –Surveys –Member lists with profiles German CDISC User Group Meetings –CDISC News –Case Studies and Best Practices –Work Streams

29. 29 Other CDISC User Groups Update 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

30. 30 CDISC News Selected regional user group updates English CDISC User Group –Overview on CDISC models –Trial Design Model implementations –TC recordings (LiveMeeting) –User discussions what was done, what were the lessons learnt Review of real SDTM focused implementations Achieving system integration How have companies handled terminology (e.g. company terminology versus CDISC terminology) How have companies handled bought-in applications contributing to CDISC implementation (developing a business case, choosing a vendor, working with the vendor to implement the application, vendor support, measuring benefits) Delaware Area –CDASH introduction and practical implementation tutorials –SDTM mapping tutorials –Introduction to the CDISC Analysis Data Model (ADaM) Implementation Guide –Overview/Update of the Oncology SDS subteam, and the proposed Tumor Identification and Tumor Results (measurements) domains –Overview of SDTM v3.1.2 feedback –Contribution to CDISC Controlled Terminology Terminology gap analysis spreadsheet

31. 31 CDISC News Selected regional user group updates Research Triangle Park –CDISC roadmap and overview on CDISC models –ADaM Overview, Case Study and Discussion –New SAS tools –Discussion on the implementation of SDTM –Discussion on tools for CDISC implementation –Posting of relevant job openings Washington, D.C. Area –CDISC roadmap and overview on CDISC models –Integrated CDISC Safety Data Pilot –PDUFA IV IT Plan overview by FDA

32. 32 Other CDISC User Groups Further information US CDISC User GroupsWeb address Atlantic (NY, NJ, PA)http://tech.groups.yahoo.com/group/NJNYPA_CDISC_UN/ Bay Areahttp://www.bayareacdisc.org/index.htmlhttp://www.bayareacdisc.org/index.html (dead link) Boston Areahttp://finance.groups.yahoo.com/group/BostonCDISC/ Chicago??? Delaware Areahttp://tech.groups.yahoo.com/group/DV_CDISC_UN/ Research Triangle Parkhttp://tech.groups.yahoo.com/group/rtp_cdisc/ Seattlehttp://tech.groups.yahoo.com/group/SeattleCDISC/ Washington, D.C. Areahttp://www.dcdisc.org/ European CDISC User GroupsWeb address German CDISC User Grouphttp://tech.groups.yahoo.com/group/german_cdisc_ug/ English CDISC User Grouphttp://tech.groups.yahoo.com/group/european_english_CDISC_ug/ French CDISC User Grouphttp://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/French %20Language/default.aspx Italian CDISC User Groupnot yet established Nordic CDISC User Grouphttp://finance.groups.yahoo.com/group/NCGUN/

33. 33 CDISC News General news BRIDG – M. Regenass, Wega Informatik AG ADaM – E. Sennewald, Kendle

34. 34 CDISC News Upcoming webcasts The CDISC-HL7 Protocol Representation Standard: Monday, September 8, 2008 11am-12:30pm Eastern Time USA This webcast will explore the benefits and value of a protocol representation standard and will provide an update on the progress that has been made through a joint CDISC and HL7 project. There will be an introduction of the history of the structured protocol, followed by a presentation on the Trial Design Model, which is used in both the protocol standard and the CDISC standard for regulatory submission of case report form data Study Data Tabulation Model (SDTM), and a presentation on the Biomedical Research Integrated Domain Group (BRIDG) model, into which the protocol standard is harmonized along with other standards for protocol-driven research. Two implementations will be reviewed – one on the use of structured standard eligibility criteria (enhanced to be specific to a therapeutic area) for identifying potential study subjects and one on facilitating study start-up from protocol through CRF generation through the use of the Protocol Representation Standard and the CDISC Operational Data Model (ODM).

35. 35 CDISC News v-Learning CDISC is now offering training courses and conference proceedings in a virtual learning format. The virtual learning format - a computer based, web delivered - allows for students to learn at their own pace on their own schedule –The sessions are available online for use on the students own desktop –Users gain access to interactive CDISC topics and courses –The course content is the same material which is taught in an instructor-led classroom –Sessions contain audio and video demonstrations, self study workshops and solutions V-Learning modules currently available: –CDISC Submission ReadinessCDISC Submission Readiness –Intro to CDISC New!Intro to CDISC –Intro to BRIDG New!Intro to BRIDG –CDISC 2008 European Interchange conference New!CDISC 2008 European Interchange conference

36. 36 CDISC News Upcoming events PhUSE 2008 Conference Working in a Global Environment 12 - 15 October 2008 The Midland Hotel 26 Brabyne Brow, Stockport Manchester SK6 5DT Preliminary Program Focus on Clinical Programming, Data Management and Statistics CDISC stream and panel discussion http://www.phuse.eu/Conference- 2008.aspxhttp://www.phuse.eu/Conference- 2008.aspx CDISC 2008 International Interchange 26 - 31 October 2008 Marriott Crystal Gateway 1700 Jefferson Davis Highway Arlington, VA 22202 Preliminary Program Training courses Workshops Main conference with parallel tracks http://www.cdisc.org/events/index.html

37. 37 CDISC Case Studies ODM-based CRF print-outs and SAS export – M. Walter, Roche Diagnostics GmbH CDISC-based eSubmission – M. Kawohl, Accovion GmbH

38. 38 CDISC User Group Work Streams ODM – Michael Walter, Roche Diagnostics GmbH (a.i.) SDTM – K. Hellstern, Hands-On GmbH ADaM – E. Sennewald, Kendle Define.xml – M. Kawohl, Accovion GmbH

39. 39 CDISC User Group Work Streams Goals Sharing of expertise and knowledge –Sharing of useful tools (e.g. Stylesheets, ODM vendor extensions, SAS macros) –Joint mock eSubmission –Test new CDISC models and provide joint feedback Identification of implementation examples –Case studies –Best practices document Identification of implementation issues –Discussion of implementation issues and proposal of joint solutions / implementation approaches –Case studies, FAQs New requirements –Requirements document (e.g. stylesheet improvements, new SDTM domains) Goals 2009 –What do we want to achieve? –Meeting schedules of work streams

40. 40 3rd German CDISC User Group Meeting Agenda - Afternoon TimeTopicWho 14:00CDISC Case Studies ODM-based CRF print-outs and SAS export CDISC-based eSubmission M. Walter M. Kawohl 15:00CDISC User Group work streams ODM SDTM ADaM Define.xml Work stream leaders, All 16:15Afternoon BreakAll 16:30CDISC User Group Discussion Work stream summaries Best practices Topics of interest Next meeting Q&A All 16:55Closing remarksD. Rehn

41. 41 CDISC User Group Discussion Work stream summaries Best practices Topics of interest Next meeting / Meeting locations Q&A

42. 42 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