What to Expect During a Quality Assurance/Quality Improvement Review

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

The IRB is responsible for ensuring compliance with University policy, Federal requirements and the ethical principles of the Belmont Report. As part of this responsibility, the IRB is expected to provide for post- approval monitoring of research. The QA&I Review is designed to meet this requirement through a pro-active and collaborative process with investigators. The purpose of the QA&I Review is to provide information to faculty and staff on regulatory compliance and Good Clinical Practice (GCP) Guidelines related to human research participants, data collection and data management; to verify that safeguards protecting the rights and welfare of human research participants are met; to verify investigator adherence to the study design as approved by the IRB-approved protocol, and applicable regulatory requirements; and rarely, to investigate complaints and/or allegations of noncompliance with research regulations. 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&I Review will entail a visit to your site. The review will vary depending on the complexity of the study and the enrollment. It is usually a good idea for the PI and/or study coordinator to be there in the morning before the visit begins and 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 reviewer 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 reviewer be looking at during the site visit?

The scope of review or investigation may vary depending on a number of factors. All site reviews or investigations will be preceded by a pre-review meeting explaining the parameters of the review. The Scope of Review may include some, or all of the following items:

  • The QI Officer will be looking to see documentation that you are following your approved protocol and study procedures.
  • The QI Officer will want to see all study related documents including:
    • original signed consent forms
    • subject files
    • inclusion/exclusion checklists
    • experimental drug/device accountability
    • AEs, SAEs
    • regulatory files (GCP Essential Documents) 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 normal reference ranges
    • Investigator Brochure

Can I prepare ahead of time?

Yes, there are a few things you can do to prepare ahead of time. 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 QI Officer has completed the review, a draft of the Report of Review Findings (RRF) will be sent to the PI (usually within about 1-2 weeks of the review date). The PI will have at least five days to read and comment on the report. Once the PI and QI officer agree that the content of the report is accurate, the report will become final. 

If the findings indicate that the study is compliant, the PI will be notified that the review is concluded.   In the event possible non-compliance is discovered during the course of the review, the PI is asked to submit a corrective action plan to address the report findings.  Once the corrective action plan is received, it is sent with the RRF to IRB reviewers for assessment.  Once the IRB has assessed the report and a corrective action plan has been approved, the PI will be asked to implement the plan and to notify the QI Officer that implementation has been initiated. Once the QI Officer has been notified that the implementation of the corrective action plan has been initiated, the QI Officer will send a close out letter and the review will be finished.

Who receives a report of the routine on-site review or directed investigation findings?

On completion of a compliance review or directed investigation, the QI Officer will draft a report of the findings and send it to the Principal Investigator, the IRB committee chairs, and the Director of Research Integrity. The Principal Investigator will have at least five days to respond to the issues.

If the IRB determines that serious or continuing noncompliance occurred, the report may be distributed to some or all of the following individuals and agencies:

  • Department Chair
  • Vice Dean/Institution Official
  • Regulatory and/or Funding Agency