SDTM Validation Rules Project

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The purpose of this project is to continue the effort of improving SDTM validation rules, ensuring that all rules are both clear and effective for use by industry and by FDA. The goal is to determine new rules that will add value and manage rules that need clarification. This will involve coordinating with CDISC, OpenCDISC and FDA to propose solutions.

Background The SDTM Validation Rules project will continue the progress that was made in the “CAP/VP OpenCDISC Rules Reconciliation and the “Top 20 Validation Rule Failures projects in 2012.

Version 1.4 of OpenCDISC, which will be released in March 2013, has put in place many of the recommendations from these projects. The 2013 SDTM Validation Rules Project will address the yet un-resolved rule discussions, as well as those
that are of special interest to FDA.
Upcoming Meetings The SDTM Validation Rules Project Team meets every [DAY TIME TIMEZONE] To join the team, please contact [PROJECT LEAD] or [LISA LYONS] Rules Currently Under Review [Add Rules]


Meeting Minutes