Study Protocol Version Study Population Description

The textual representation of the subject characteristics, including inclusion and exclusion criteria and describes the population for which the study may be generalized. (NCI Thesaurus)

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Study Protocol Version Responsible Party Code

A coded value specifying the type of entity who is legally responsible for the execution of the study.

Study Protocol Version Purpose Statement

A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what…

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.