" /> Subject Evaluability Criteria and Classification Document - CISMeF





Preferred Label : Subject Evaluability Criteria and Classification Document;

NCIt related terms : Population Definition Criteria; Subj Eval Crit; Protocol Violations; Deviations and Exemptions; Protocol Deviation Listing; Subject Evaluability Criteria and Subject Classification;

NCIt definition : Records detailing clearly defined criteria, which are used to evaluate and assign study subjects to a population group, established by a statistical analysis plan (SAP).;

Alternative definition : CareLex: To document the decisions which define the criteria applied to evaluate each subject in the trial, in order to that will unambiguously assign the subject to the populations established in the (SAP). [Adapted from TMF-RM];

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02/06/2024


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