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Protocol Disposition Event
The group of incidents that occur during a clinical trial and describe whether a subject completed the study epoch or the reason this event did not occur. The subject's disposition is often described for each phase of the study. (NCI Thesaurus)
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A clinical study protocol review status designating the protocol that was denied the approval.
A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to protocol deviations.
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.
