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Study Protocol Version Study Schematic
Diagram which outlines all study epochs, timing of randomization and duration of treatments. (NCI Thesaurus)
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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…
A coded value specifying the type of study based upon the intent of the study's activities.
A description of what the study subject can expect to experience over the course of the study, including the sequence and duration…
The intended period of time for the study.