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Performed Study Administrative Activity
Definition 1
The completed study level administrative activity that is independent of a study subject. (NCI Thesaurus)
Definition 2
The completed study level administrative activity that is independent of a study subject. EXAMPLE(S): IRB Approval, site enrollment, FDA audit (NCI Thesaurus/BRIDG)
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Specifies whether the participant had abstained from eating when the specimen is obtained.
The completed action of gathering samples that may be used for subsequent analysis.
A coded value specifying a subdivision within a larger category of a protocol deviation. EXAMPLE(S): prohibited medication, missed dose of study medication,…
The date and time span specifying when the protocol deviation began and ended.
A coded value specifying a classification of protocol deviation.
A variation from process or procedures defined in a study protocol.