Interventional Study Protocol Version Intervention Group Quantity

Definition 1

An integer specifying the number of intervention groups. (NCI Thesaurus)

Definition 2

An integer specifying the number of intervention groups. EXAMPLE(S): Enter 1 for single-arm study. NOTE(S): This attribute is potentially derivable once the study design has been defined. (NCI Thesaurus/BRIDG)

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Interventional Study Protocol Version Control Type Code

A coded value specifying the kind of comparison or comparator against which the study treatment is evaluated.

Interventional Study Protocol Version Control Concurrency Type Code

A coded value specifying the temporal relationships of the control to the study intervention.

Interventional Study Protocol Version Blinding Schema Code

A coded value specifying the type of masking used on a study protocol to ensure that the results are not biased by…

Interventional Study Protocol Version Blinded Role Code

A coded value specifying the roles of individuals who are masked for single or double blind studies.

Interventional Study Protocol Version Allocation Code

A coded value specifying the method of assigning subjects to treatment or control groups.

Interventional Study Protocol Version Accepts Healthy Volunteers Indicator

Specifies whether persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility…