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QA/QI Frequently Asked Questions

How am I notified of a routine QI review?

You will receive an email from the QI manager notifying you of the study under review.

How much time will I have to prepare for a review?

All files are expected to be maintained in a review-ready state at all times. However, for routine reviews, the QI manager will notify you of an impending review usually within 4 weeks in advance. For directed or for-cause reviews, the timeline as specified by the requester will determine the amount of advance notice.

What study documents will be reviewed?

All documents related to the study may be reviewed. Specifically, subject signed informed consents, HIPAA, IRB approvals, sponsor regulatory documents, IRB and sponsor correspondence, drug and device logs, all study-related data, etc.

What do I need to do to prepare for my review?

The QI manager will forward you a study self-assessment checklist to help you prepare and collect all necessary documents for this review.

How much time does a review take?

The time it takes to perform a routine QI review of your study depends on the number of subjects enrolled and the complexity of the study.

What happens after the review is over?

The QI manager will meet with the Principal Investigator (PI) and study team to go over findings of the review. The QI manager will then compile the results into a report with best practice corrective action recommendations. This report will be sent to the Principal Investigator and other persons the PI may designate within 3 business days. Should findings indicate issues that should be reported to the IRB as Reportable New Information (RNI), it is the PI's responsibility to notify the Institutional Review Board (IRB) within 5 business days of receipt of this report.