Preferred Label : Clinical Trial Subject Evaluability Criteria and Subject Classification Documentation;
NCIt related terms : Population Definition Criteria; Subj Eval Crit; Protocol Violations; Deviations and Exemptions; Protocol Deviation Listing; Subject Evaluability Criteria and Subject Classification;
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]; CDISC: Documentation detailing the decisions that define the criteria used to evaluate
and assign subjects to a population group, which are established by the statistical
analysis plan of the clinical trial.;
Origin ID : C115735;
UMLS CUI : C3890888;
Semantic type(s)
- concept_is_in_subset
