ODM Work Stream Summary

ODM Work Stream Summary

Work Stream Template: ODM Basel, September 2, 2008 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 2 CDISC User Group Work Streams Some considerations for discussion ODM Work Stream:

ODM-based archival concept CDASH integration ADaM Work Stream: (Automated) generation of ADaM datasets from SDTM Macros SDTM Work Stream: Proposal of new domains Define.xml Work Stream: Macros Stylesheet improvements Executable expressions

3 CDISC User Group Work Streams Sharing of expterise and knowledge Teilnehmer Markus Stoll, IBM Uwe Lahr, Dr. streich+Partner Fred Kiefer, ClinIT Michael Walter, Roche Diagnostics GmbH Alle CDISC ODM Training in Kopenhagen Wo ist CDISC ODM einzugruppieren (mit anderen Standards) , wird es

weiterentwickelt, wie? CDISC ODM Checker, wird dieser fr CDISC ODM version 1.3 weiterentwickelt? Proc CDISC Weiterentwicklung? SDTM ETL (ODM SDTM Transformationstool)? Kann eine Layout Extension zum CDISC ODM Standard hinzugefgt werden? 4 CDISC User Group Work Streams Identification of implementation examples CDISC ODM Implementierung fr CIM SAS Schnittstelle [Proc CDISC] und

CRF-Printing (Export von klinischen Daten) in CIM [Michael Walter] Prototyp fr ODM Ausgabe [email protected] [Fred Kiefer] 5 CDISC User Group Work Streams Identification of implementation issues Proc CDISC ldt keine Vendor Extension Checker kann kein ODM 1.3 Handling von repeating items Handling of response status

6 CDISC User Group Work Streams New requirements Standards enger verzahnen Requirements an EDCSysteme, um die Standards besser zu untersttzen 7 CDISC User Group Work Streams Goals 2009

Roadmap CDISC ODM und Positionierung von CDISC ODM im CDISC Umfeld White Paper fr CDISC ODM Implementierung (Fallbeispiele) bzw. CDISC 8

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