StudyDataReviewersGuide/CDISC Interchange 2012

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The WG4 Data Guide co-leads met during the CDISC Interchange to discuss the state of the project and move forward with development of the Data Guide Template. The team discussed the content created by the three sub-teams - Study Level, Data Description, and Validation. The discussions further refined the content in these sections and the team felt comfortable at the close of the discussions that the topics (headings) for a template had been defined and that a first draft of a set of completion instructions could be finalized within a week of the meeting.

The team clarified the scope for the Data Guide. The Data Guide or Study Data Reviewer's Guide (SDRG) as it will be re-branded will proposed as a component of the eCTD's Module 5 SDTM data documentation. The scope of this project will be limited to SDTM and future projects will address the Analysis Data Reviewer's Guide.

The team discuss deliverables and timelines for the project. These will be posted to the PhUSE Wiki shortly after the Interchange.