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Protocol Deviation Category
A classification of protocol deviation data. (NCI Thesaurus)
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An unintended departure from the study plan which has not been prospectively reviewed and approved by the IRB and FDA.
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A clinical study protocol review status designating the protocol that was deferred pending additional information or/and action(s).
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A person at the primary location of research that retains the responsibility for regulation compliance and ensures the proper administration of the…
A person who is the writer of a structured research study.
