Work Stream Templates 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

CDISC User Group Work Streams Some considerations for discussion ODM Work Stream: ODM-based archival concept CDASH integration SDTM Work Stream: Proposal of new domains ADaM Work Stream: (Automated) generation of ADaM datasets from SDTM Macros Define.xml Work Stream: Stylesheet improvements Executable expressions

CDISC User Group Work Streams Sharing of expterise and knowledge

CDISC User Group Work Streams Identification of implementation examples

CDISC User Group Work Streams Identification of implementation issues

CDISC User Group Work Streams New requirements

CDISC User Group Work Streams Goals 2009