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Study Protocol Document
Definition 1
A representation of the study protocol (that persists over time) in document form. (NCI Thesaurus)
Definition 2
A representation of the study protocol (that persists over time) in document form. NOTE(S): A StudyProtocolDocument groups the various study protocol document versions. (NCI Thesaurus/BRIDG)
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A characteristic that defines how the disclosure of protocol content is controlled.
The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the…
An assignment to a portion of a study based on a set of criteria that ensures a desired distribution of subjects across…
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…
A textual description of the target study population which contains precisely defined characteristics of potential participants. This includes inclusion and exclusion criteria,…
A target study population with characteristics, including inclusion and exclusion criteria, precisely defined in the study protocol. This is a population…
