Berlin, February 19, 2009

1. 4th German CDISC User Group Meeting Berlin, February 19, 2009

2. 4th German CDISC User Group Meeting Herzlich willkommen in Berlin!

3. 4th German CDISC User Group MeetingAgenda - Morning

4. 4th German CDISC User Group MeetingAgenda - Afternoon

5. CDISC User Group Organization Overview on new German CDISC User Group Portal Overview on other User Group’s activities

6. German CDISC User Group PortalIntroduction http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

7. German CDISC User Group PortalSelected contents of User Manual Public access (basic read rights) • Reading content • Downloading documents • Participating in discussions Access with contributor user rights (write rights, extended read rights) • Signing in • Signing out • Changing the password • Forgotten password • Entering the wrong password • Updating My Settings • Uploading and modifying content • Uploading and modifying documents • Adding and modifying calendar items • Exporting calendar items • Adding and modifying contacts • Exporting contacts • Adding and modifying tasks • Alerts • Setting alerts to document libraries and lists • Setting alerts to single items • Viewing or modifying existing alerts • Deleting alerts http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

8. Global CDISC User Network Regional CDISC User Groups US User Groups European User Groups English CDISC User Group Midwest (Chicago) Nordic CDISC User Group Seattle Boston Area Heartland Atlantic (NYC area) Washington, D.C. Area Delaware Valley German CDISC User Group Bay Area French CDISC User Group Research Triangle Park Italian CDISC User Group

9. English CDISC User Group Overview on CDISC models Trial Design Model implementations TC recordings (LiveMeeting) User discussionswhat 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 Global CDISC User NetworkUpdate from selected regional user groups (1)

10. 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 Interim Report on CDISC Pilot incl. panel discussion with FDA Define.xml tutorial Global CDISC User NetworkUpdate from selected regional user groups (2)

11. Global CDISC User Network Further information

12. CDISC News General news – D. Rehn SDTM IG 3.1.2 – K. Hellstern CMDR BMBF Project – S. Semler

13. CDISC Metadata Repository (CMDR)Background • Currently there are 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) though – in clinical trial space - many are now moving to the use of SDTM and ADaM • However, SDTM and ADaM 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. This impacts all organizations as well as impacting patient safety. • The creation of the CMDR, populated with industry standard concepts and variables, will address the shortfall enabling rapid evaluation of drug safety across company boundaries, improving operational efficiency in the collection, processing and reporting of data and enhancing scientific capability due to the dramatic increase in data reuse capability.

14. CDISC Metadata Repository (CMDR)Overview • The data collected in clinical care and in clinical research, as well as in pre-clinical research, can be captured and stored as a collection of concepts and variables. • A concept provides a definition of a particular piece of information together with a link to the variables used to store the information. • The CMDR is the repository of the definition of concepts and related variables • Concepts will be unambiguous as they inter-relate to context/other concepts through an information model (e.g. BRIDG) and through abstract data types (HL7/ISO abstract data types) • Variables will be unique (or there will be a "golden standard" variable to be used) • The CMDR is based on linked/constrained controlled terminologies i.e. a findings like systolic blood pressure is related to body position, devices, target site....  • The CMDR will initially focus on clinical trial, epidemiology, HEOR and pharmacovigilance. • In a second stage pre-clinical and research should be considered, as well as extension for medical devices and EHR integration • Within Clinical trials, the CMDR will encompass safety and efficacy data together with CDISC trial design data

15. CDISC Metadata Repository (CMDR)Use case – Protocol/Scientist • Dr Joe is the principal author of the protocol for a new study. • In the past he would have written the protocol on paper and had it reviewed and approved before passing it to the data manager responsible for data collection and (e)CRF development. • Today Dr Joe is working with a new tool – called eProtocol manager – which helps him to enter the protocol in a more formal way. The tool has a "template" for writing the protocol, and each part of the template has a degree of structure appropriate to that part. • Wherever the content of the protocol refers to scientific concepts, protocol text is linked (either automatically or manually) with a well-defined concept with CMDR. • The protocol tool produces a report on draft concepts, which will be submitted to the CMDR for validation and for linking to relevant data items. • The protocol tool passes information on concepts and variables to the data manager and/or eCRF developer. Where Dr. Joe has not completely specified data collection, they complete the task.

16. CDISC Metadata Repository (CMDR)Development streams

17. v-LearningIntroduction • 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 student’s 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 Readiness • Intro to CDISC • Intro to BRIDG • CDISC 2008 European Interchange conference

18. v-LearningExample: CDISC Submission Readiness (1) http://online.vdestiny.com

19. v-LearningExample: CDISC Submission Readiness (2) http://online.vdestiny.com

20. Upcoming eventsCDISC Interchange Europe CDISC Interchange Europe 20 – 24 April 2009 The Corinthia Grand Hotel Royal Budapest, Hungary ‘Standards in Style‘ Hotel Booking Information Arrival Information Conference 22 - 23 April 2009 Training 20, 21 & 24 April 2009 Registration and Programme information forthcoming.

21. 4th German CDISC User Group MeetingAgenda - Afternoon

22. CDISC Case Studies CDASH tutorial – E. Sennewald CDASH, electronic medical records and ODM – status update – J. Aerts CDASH – SDTM mapping and other discussion topics – K. Hellstern

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

24. CDISC User Group Work StreamsGoals • Sharing of expertise and knowledge • Test new CDISC models and provide joint feedback • Sharing of useful tools (e.g. Stylesheets, ODM vendor extensions, SAS macros) • Joint mock eSubmission • Identification of implementation examples • Case studies • Best practices document • Identification of implementation issues • Discussion of implementation issues and proposal of joint solutions / implementation approaches • 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

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

26. Herzlichen Dank! • Bis zum nächsten Mal und… • weitere Teilnehmer sind immer willkommen! • Kontakte: • Chair/Coordinator: Daniel Rehn (daniel.rehn@roche.com) • ODM Work stream: Jozef Aerts (jozef.aerts@xml4pharma.com) • SDTM Work stream: Kurt Hellstern (kurt.hellstern@hands-on.ch) • ADaM Work stream: Elke Sennewald (sennewald.elke@kendle.com) • Define.xml Work stream: Monika Kawohl (monika.kawohl@accovion.com) • Organization/Interfaces: Sebastian Semler (sebastian.semler@tmf-ev.de)