Study Protocol Version Target Accrual Number Range

Definition 1

A range of integers specifying the minimum and maximum number of subjects to be accrued for the study. (NCI Thesaurus)

Definition 2

A range of integers specifying the minimum and maximum number of subjects to be accrued for the study. NOTE(S): A typical target accrual number (always assumed to be a minimum target) would be targetAccrualNumberRange.IVLINT.low, a maximum target accrual would be targetAccrualNumberRange.IVLINT.high. (NCI Thesaurus/BRIDG)

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Study Protocol Version Study Subject Type Code

A coded value specifying the target entity of the study of investigation.

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.