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Protocol Deviation Dictionary Derived Term
The literal identifier of a protocol deviation as determined by a standards organization. (NCI Thesaurus)
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Symbol(s) used to designate specific protocol deviations.
A classification of protocol deviation data.
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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