Human Research Protection Program

HITECH Act

What to Expect During a Quality Assurance/Quality Improvement Review

Frequently Asked Questions

I just received a letter telling me I’m going to have a Quality Assurance/Quality Improvement Review. What does this mean?

The Yale IRBs are responsible for ensuring compliance with University policy, Federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRBs are expected to provide for post- approval monitoring of research protocols to ensure continued compliance with all applicable policies and regulations and to ensure adherence to the protocol plan. The QA/QI Review is designed to meet this requirement through a pro-active and collaborative process with investigators. The studies that are chosen for review are picked randomly and the review is meant to be a collaborative process whereby the auditor assesses compliance (regulatory, policy, approved protocol, etc.) and helps the investigator resolve/correct problems and discrepancies and provides recommendations for process improvements.

What does a QA/QI Review entail?

A QA/QI Review will entail two visits to your site. The first visit will be a short (usually about a half hour) introductory visit to tell you what to expect, to address any questions or concerns and to ensure there is adequate space for the auditor to conduct the review. The full QA/QI review usually takes an entire day. The review will take place shortly after the introductory visit at a mutually agreed upon date. It is usually a good idea for the PI and/or study coordinator to be there in the morning before the visit begins and at the end of the day when the review is over. The PI does not need to be present for the entire review unless s/he wants to be. However, a staff member should be available to provide the auditor with the necessary documents, files and binders and answer any questions (or to contact the PI if there is an urgent question).

What will the auditor be looking at during the site visit?

The auditor will be looking to see documentation that you are following your approved protocol and study procedures. The auditor will want to see all study related documents including: signed consent forms, subject files, inclusion/exclusion checklists, experimental drug/device accountability, AEs, SAEs, regulatory files such IRB files and correspondence, sponsor correspondence, FDA files and related documents (if applicable), enrollment logs, staff signature logs (delegation of responsibility logs), laboratory certifications and normals, and Investigator Brochure.

Can I prepare ahead of time?

Yes, there are a few things you can do to prepare ahead of time. Complete the self-assessment checklist which was provided with the QA/QI letter. Review each consent form to ensure the correct version was used and that it has been signed/dated properly by the subject. If you find a problem with a consent form, make a note in the study file and fix the problem as soon as possible (notify IRB). Review your regulatory binders (IRB, FDA, etc.) and make sure you have all IRB, sponsor, FDA correspondence in the Regulatory File and that the files are in order. Review and update the subject enrollment log (if you have one).

What happens after the review is over?

Once the auditor has completed the review, a Findings Report will be generated and sent to the PI (usually within about 1-2 weeks of the review date). The report will include any findings that need to be addressed, specified corrective actions, and a time frame by which the action needs to be completed. The report will also include any recommendations for process improvements. Once the investigator responds to the report and all the issues have been adequately addressed, the auditor will send a close out letter and the review will be finished. If any incidents of serious or continuing non-compliance are found during the review, the auditor will bring it to the PI’s attention and immediately start working with the PI to address the issue.