Clinical Trial Subject Evaluability Criteria and Subject Classification Documentation

**Semantic type:** Intellectual Product

**Definition:** 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.

**Synonyms:** - Deviations and Exemptions - Population Definition Criteria - Protocol Deviation Listing - Protocol Violations - Subj Eval Crit - Subject Evaluability Criteria and Subject Classification - Subject Evaluability Criteria and Subject Classification - Subject Evaluability Criteria and Subject Classification