Potential Study Subject

**Semantic type:** Human

**Definition:** A living individual who, due to the possession of one or more characteristics such e.g. as a particular medical condition specific to the study, is pre-qualified as a prospective study subject. A potential subject becomes eligible for the clinical study if he meets the study protocol eligibility criteria and voluntarily gives a legally effective informed consent to participate in the study (except when a waiver for informed consent is granted under FDA and OHRP guidelines).

**Synonyms:** - Potential Clinical Study Participant - Potential Clinical Study Subject - Potential Clinical Trial Participant - Potential Human Clinical Study Subject - Potential Study Participant - Potential Subject