Study Protocol Document Version

Definition 1

A representation of a particular edition or snapshot of a document containing a study protocol as it exists at a particular point in time. (NCI Thesaurus)

Definition 2

A representation of a particular edition or snapshot of a document containing a study protocol as it exists at a particular point in time. EXAMPLE(S): Version 3 of a breast cancer protocol. NOTE(S): A version of the study protocol represents the characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document. A StudyProtocolDocumentVersion is related to other supporting document versions involved in the study, 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 term "Amendment" needs to be disambiguated since it sometimes refers to the amended version of the protocol (BRIDG's StudyProtoclDocumentVersion) and other times refers to the summary of changes. (NCI Thesaurus/BRIDG)

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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.

Study Protocol

The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the…

Study Position

An assignment to a portion of a study based on a set of criteria that ensures a desired distribution of subjects across…

Study Population Subgroup

Relatively uniform groups (e.g. etiologically and pathogenetically more homogeneous, racial, ethnic, or gender-specific, or the disease- or condition-specific) of study subjects formed…

Study Population Description

A textual description of the target study population which contains precisely defined characteristics of potential participants. This includes inclusion and exclusion criteria,…