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Get Sop: 304 Documentation, Document, And Data ... - Ouhsc

E history of all IRB actions related to review and approval of a protocol, including continuing reviews, amendments, and unanticipated problems involving risks to participants or others. The IRB Office shall maintain documents related to study protocols as well as to IRB and Privacy Board proceedings pursuant to federal, state, and local regulations, sponsor requirements, and organizational policies and procedures. All records regarding a study submission (regardless of whether it is approved) s.

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