Study Protocol Version

Definition 1

A plan at a particular point in time for 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. (NCI Thesaurus)

Definition 2

A plan at a particular point in time for 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. NOTE(S): The notion of a study includes (but is not limited to) the design, statistical considerations and activities to test a particular hypothesis or answer a particular question that is the basis of the study. The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The complete notion of the study is represented by the Study class and all its associations which make explicit the details identified in the StudyProtocolDocument. (NCI Thesaurus/BRIDG)

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Study Protocol Document Version Scientific Description

The textual summary of a document that includes extended scientific or technical information.

Study Protocol Document Version Public Title

The title of the document intended for the general population.

Study Protocol Document Version Public Description

The textual summary of a document intended for the general population.

Study Protocol Document Version

A representation of a particular edition or snapshot of a document containing a study protocol as it exists at a particular point…

Study Protocol Document

A representation of the study protocol (that persists over time) in document form.

Study Protocol Confidentiality Status

A characteristic that defines how the disclosure of protocol content is controlled.