DEFINITION:<br /></p><p>A discrete, structured plan (that persists over time) of a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. <br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>ClinicalTrials.gov study NCT01632332 Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer. The study protocol includes the elements identified in the NOTE(S) section.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>The term "protocol" is somewhat overloaded and must be qualified to provide semantic context.  Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization).  The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational.  Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship).  The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyConduct and all their associations.<br /></p><p>- The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form.<br /></p><p>- The StudyProtocolVersion class represents the details of the study protocol that may change over time.<br /></p><p>- The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions.<br /></p><p>- The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time.<br /></p><p>- The StudyConduct class represents the execution of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities.<br /></p>