Study Protocol Version Target Anatomic Site Code

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

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

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

The textual representation of the subject characteristics, including inclusion and exclusion criteria and describes the population for which the study may be…

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

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