Study Protocol Version Study Subject Type Code

Definition 1

A coded value specifying the target entity of the study of investigation. (NCI Thesaurus)

Definition 2

A coded value specifying the target entity of the study of investigation. EXAMPLE(S): Human (for clinical trials); Rats, mice (for other studies) (NCI Thesaurus/BRIDG)

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Study Protocol Version Study Schematic

Diagram which outlines all study epochs, timing of randomization and duration of treatments.

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…

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…