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What does the study team need to do to prepare for an upcoming routine review?

April 26, 2017prepare review routine study TEAM upcoming

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What does the study team need to do to prepare for an upcoming routine review?

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Ensure documents are available for review. In a routine review the QI staff will always review signed consent forms and the regulatory file. Periodically QI will review other documents such as study subject files, enrollment logs, product accountability records and other research records. QI will discuss the scope of the review in conjunction with your acceptance of the invitation. For more information, please contact a Quality Improvement Specialist.