Study Protocol Version Purpose Statement

Definition 1

A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study. (NCI Thesaurus)

Definition 2

A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study. NOTE(S): This differs from StudyObjective which describes what the study hopes to accomplish whereas the purposeStatement is the reason why the study is being conducted. (NCI Thesaurus/BRIDG)

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Study Protocol Version Primary Purpose Code

A coded value specifying the type of study based upon the intent of the study's activities.

Study Protocol Version Planned Study Subject Experience

A description of what the study subject can expect to experience over the course of the study, including the sequence and duration…

Study Protocol Version Planned Duration

The intended period of time for the study.

Study Protocol Version Phase Code

A coded value specifying the designation of approval phase for a study.

Study Protocol Version Periodic Target Accrual Number

A range of integers specifying the minimum and maximum number of subjects to be accrued per a specified amount of time. …

Study Protocol Version Participating Organization Type Code

A coded value specifying the kind of organizations planned to participate as study sites for this study.