German CDISC User Group
Meeting Summary
The 3rd German CDISC User Group Meeting took place at F. Hoffmann-La Roche AG in Basel on 2 September 2008 and 35 participants attended.
The first topic dealt with the German CDISC User Group organization and Daniel Rehn, the chair of the user group, presented his ideas on how to move forward. As a result, the participants approved the Bylaws document and elected both the Chair and a Steering Committee to serve a term until (and including) the first user group meeting in 2010. In addition, the user group decided on establishing four Work Streams to discuss CDISC model implementations in-depth at a monthly or bi-monthly basis. Each work stream is led by a dedicated member of the Steering Team.
The Steering Team consists of the following people:
- Jozef Aerts, XML4Pharma GmbH: ODM Work Stream
- Kurt Hellstern, Hands-On GmbH: SDTM Work Stream (incl. CDASH and Terminology)
- Monika Kawohl, Accovion GmbH: Define.xml/eSubmission Work Stream
- Daniel Rehn, F. Hoffmann-La Roche AG: Chair
- Elke Sennewald, Kendle: ADaM Work Stream
- Sebastian Semler, TMF e.V.: Organization, Interfaces
The User Group also discussed its ideas of a future CDISC User Group Portal and put that into context on how the user group portals are currently implemented by CDISC. This discussion resulted in a joint requirements document which was sent to and discussed with CDISC.
In the topic “CDISC News” Mark Regenass from wega informatik AG and Elke Sennewald from Kendle talked about recent advances in BRIDG and the draft ADaM implementation guide v1.0, respectively. In the name of the German CDISC User Group, E. Sennewald sent jointly collected comments on the ADaM implementation guide to the ADaM team. In the topic “CDISC case studies”, M. Walter from Roche Diagnostics GmbH introduced the user group into the implementation of ODM-based CRF print-outs and ODM-based SAS export and discussed the potential pit-falls identified during the course of that project. And Monika Kawohl from Accovion GmbH talked about her experiences with define.xml and CDISC-based eSubmissions.
The afternoon was dedicated to the newly established Work Streams. The Work Stream Leaders discussed with the participants their ideas and scope of their corresponding work streams and jointly defined common goals for 2009. Generally, the work streams agreed to share best practices, to identify implementation issues and, if applicable, to connect to the responsible CDISC teams for general feedback or specific change requests.
All presentations and work stream summaries are available on the German CDISC User Group Portal (
The German CDISC User Group agreed to meet three times next year: In the first week of February 2009 in Berlin, at the European CDISC Interchange 2009 and in the second half of September 2009, again in Basel. New participants are always welcome!
Daniel Rehn