German CDISC User Group
Meeting Summary
The 4th German CDISC User Group Meeting took place at Parexel GmbH in Berlin on 19 February 2009 and 53 participants attended.
The first topic dealt with the German CDISC User Group organization and Daniel Rehn, the Coordinator of the German CDISC User Group, reported on the recent developments of the CDISC User Group Portal structure and processes, based on the joint requirements paper developed by the German CDISC User Group last year. As a result, all German CDISC User Group members have now access to their portal site as so-called Contributors allowing them to efficiently exchange information by accessing and adding all different portal contents. And for the Workstreams dedicated sub-sites have been made available where their discussion materials and minutes are stored being available to everyone. Based on the well-advanced German CDISC User Group Portal, a User Manual was prepared by Daniel Rehn in the name of the CGUN Communication Committee for all User Group Members world-wide. This document describes all functionality for the public, for Contributors and for Portal Site Administrators in detail. The User Manual and FAQs on portal use can now be accessed in the Links section of the Global CDISC User Networks Portal (http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/default.aspx).
Daniel Rehn gave also an update on the Global User Network. He reported on new CDISC User Groups emerging in India, China, South Korea, Japan and Australia and pointed out some key activities of selected CDISC User Groups. The German CDISC User Group members agreed to continue monitoring key activities from other groups and to eventually reach out to them to exchange information.
In the topic “CDISC News” Daniel Rehn gave an introduction into the recent CDISC Metadata Repository project and summarized the recent activities. Also a live demonstration of the v-Learning module “CDISC Submission Readiness” was provided to enable the User Group members to decide on whether this may be a suitable tool for them. Johannes Drepper from TMV e.V. took up the CMDR vision and reported on a Clinical Metadata Repository project which is sponsored by the BMBF and currently being done together with the KKS Dresden.
The topic “CDISC Case Studies” was dedicated to CDASH. Elke Sennewald from Kendle GmbH started with a very informative and hands-on CDASH tutorial. Jozef Aerts from XML4Pharma GmbH talked about the status of integrating EHR data and CDASH forms in ODM. And Kurt Hellstern from HandsOn GmbH concluded the session by giving an overview and making recommendations on how to map CDASH to SDTM.
As before, the afternoon was dedicated to the established Workstreams:
· The ADaM Workstream is setting up a case study based on an SDTM ECG data set and will create test ADaM datasets thereof by implementing the Draft ADaM Implementation Guide. Furthermore, it will standardize programs for the creation of ADaM and define.xml. Finally, it will cooperate with the define.xml/eSubmission Workstream to standardize the stylesheet used for Define.xml
· The define.xml/eSubmission Workstream will start with a collection of references regarding define.xml generation in eSubmission preparation processes. Best practices will be discussed based on sample implementations and papers available with regard to the integration of define.xml in eCTDs and special requirements for the stylesheets.
· The ODM Workstream discusses the need for future ODM extensions, e.g. ePRO extensions, electronic signatures, trial design, instrument and sample data extensions and will provide user requirements to the ODM team.
· The SDTM Workstream currently talks about standardization across studies, as all CDISC standards are focused on single studies so far. A list of questions around this topic was created which will help the SDTM Workstream to continue the discussions on this topic. Other topics will be on data management systems supporting CDISC standards on an across study level, CROs and their use of CDISC standards and issues around the Trial Design domains.
All presentations and Workstream summaries are available on the German CDISC User Group Portal (http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/).
The German CDISC User Group will meet again at the European CDISC Interchange 2009 in Budapest and in the second half of September 2009 at IBM in Boeblingen. New participants are always welcome!
Daniel Rehn