1. Basel, September 2, 2008 Work Stream Summary define.xml/eSubmissions

2. 2 CDISC User Group Work Streams Group Characteristics Sharing of expertise and knowledge Currently 5 Participants –2 Pharma –3 Service Providers Majority of workstream members have just started to familiarize themselves with the CDISC define.xml standard or are involved the early stages of CDISC based process set-ups incl. define.xml 1 member has implemented define.xml for data in CDISC SDTM format

3. 3 CDISC User Group Work Streams Identification of implementation examples A Reference List was identified as useful basis for further discussions –Publications –Presentations –Implementation samples Initial set-up: Monika Kawohl Extensions via team

4. 4 CDISC User Group Work Streams Identification of implementation issues How to integrate define.xml generation in business process –Process set-up Legacy data conversion projects New projects Depending on CDISC implementation status at sponsor See new requirements (next slide) for define.xml specific issues

5. 5 CDISC User Group Work Streams New requirements Tools that can be used to verify the schema conformance of define.xml files –Support/input from ODM workstream? Stylesheet improvements –Back button issue –Printing (may include alternate solutions) CDISC define.xml schema extension for ADaM specific metadata –Draft expected end of 2008 as per announcement at CDISC EU Interchange 2008 Reviewer‘s Guide –Template with general topics to be addressed

6. 6 CDISC User Group Work Streams Goals 2009 Prepare Reference List (publications, implementation samples) Research on XML Parser Tools to verify technical aspects of define.xml –Available tools / (experience with tools) Reviewer‘s Guide –Evaluation of Reviewer‘s Guide included in the SDTM/ADaM Pilot –Recommendation for topics to be covered Feedback to global CDISC team –Continued stylesheet support for define.xml desired Standard data to be described in a standard layout Meeting schedule to be determined at 1st workstream TC –End of October/Beginning of November –Invitation incl. agenda will be distributed to all German CDISC User Group members –Additional workstream members are welcome