should be documented in the reviewers’ guide. Examples of issues that cannot be corrected include errors in the source data and compliance check false positives.
Best practices for ADaM compliance checks include understanding the available tools to check compliance and their limitations, and the use of sponsor-defined checks.
The last presentation in the session focused on standards around questionnaire data from collection to SDTM and ADaM. There is a newly created ADaM subteam formed to develop questionnaire specific analysis subsections in the published CDISC Questionnaire Supplements. This subteam will first focus on developing analysis sections for those questionnaires that are in the public domain.
Examples of the type of scoring data that can be part of the SDTM QS datasets include algorithmically created scores created by the EDC system, scores printed directly on the CRF, or total scores used as part of the Inclusion/Exclusion Criteria. This operationally derived data resides in SDTM and may not be suitable for analysis. The ADaM datasets will include the analysis derived data by adding derived rows in addition to the data included in the SDTM datasets. Example analyses include percent change from baseline and total scores not part of the CRF. These type of analyses will be documented in the Statistical Analysis Plan (SAP). Since questionnaires are validated documents, the ADaM information in the CDISC supplements will only include published rules. Each implementer can add their rules if needed in the SAP.
All of the above subteams are looking for additional volunteers. Please consider volunteering for the ADaM team and one of the above subteams.
By Amy Palmer, CDISC Project Manager, Standards Development
Strength through Collaboration
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