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Protocol Deviations Domain
Definition 1
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to protocol deviations. (NCI Thesaurus)
Definition 2
The intent of the domain is to capture protocol violations and deviations during the course of the study and will store only those criteria violation by or deviated from by the subject and not a response to each violation or deviation. (NCI Thesaurus/CDISC)
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An indication of whether protocol deviation has occurred.
A subdivision of protocol deviation data.
The time at which the protocol deviation begins.
The date and time of the beginning of a protocol deviation.
The date on which the protocol deviation begins.
One or more sponsor-defined characters used to identify, name, or characterize the protocol deviations.
