Clinical Study Protocol

**Semantic type:** Intellectual Product

**Definition:** A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the study, but these could be represented in other protocol referenced documents.

**Synonyms:** - Full Protocol - Prot - Protocol - Protocol - Protocol - Protocol - Protocol Amendment - Study Protocol - Study Protocol - StudyProtocol - protocol