" /> Clinical Trial Database Change Control Documentation - CISMeF





Preferred Label : Clinical Trial Database Change Control Documentation;

NCIt related terms : Database Change Control;

Alternative definition : CareLex: A document, report or log summarizing changes made to a clinical trial patient database. May include the reason for change, relevant approvals, impact/risk analysis, associated requirements, specifications and other documentation describing the validation and implementation of the change.; CDISC: Documentation detailing the changes made to the clinical trial database.;

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31/05/2025


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