What to Expect During a Quality Assurance or Quality Improvement Review

Human Research Regulatory Affairs What to Expect During a Quality Assurance or Quality Improvement Review
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Human Research Regulatory Affairs What to Expect During a Quality Assurance or Quality Improvement Review

NYU School of Medicine’s Institutional Review Board (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 postapproval monitoring of research. The quality assurance and improvement review is designed to meet this requirement through a proactive collaboration with investigators.

The quality assurance and improvement review process ensures the following:

  • It educates faculty and staff on regulatory compliance and good clinical practice guidelines related to human research participants, data collection, and data management. 
  • It verifies that safeguards protecting the rights and welfare of human research participants are in place. 
  • It ensures that investigators adhere to the study design as approved by the IRB-approved protocol and applicable regulatory requirements. 
  • Rarely, it investigates complaints or allegations of noncompliance with research regulations. 

The review is a collaborative process, whereby the auditor assesses compliance (with regulatory, policy, and approved protocols, for example) and helps investigators resolve or correct problems and discrepancies and makes recommendations for improving processes.

What a Quality Assurance and Improvement Review Entails

If you receive a letter indicating that you’re going to have a quality assurance and improvement review, an auditor visits your site. The full quality assurance and improvement review usually takes an entire day, but this may depend on the complexity of the study and the enrollment. 

It is usually a good idea for the principal investigator or study coordinator or both to be there in the morning before the visit begins and at the end of the day when the review is over. The principal investigator does not need to be present for the entire review, unless he or she wants to be. However, a staff member should be available to provide the auditor with the necessary documents, files, and binders and to answer any questions or contact the principal investigator if needed.

The scope of the review or investigation depends on a number of factors. All site reviews or investigations are preceded by a notification letter from NYU School of Medicine’s quality assurance and improvement division that specifies the scope of review. It may include some or all of the following items:

  • The auditor is looking to see documentation that you are following your approved protocol and study procedures.
  • The auditor wants to see all study-related documents:
    • original signed consent forms
    • subject files
    • inclusion or exclusion checklists
    • experimental drug or device accountability
    • adverse events or serious adverse events
    • regulatory files (or good clinical practice essential documents) such as IRB files and correspondence, as well as sponsor correspondence
    • Food and Drug Administration (FDA) files and related documents (if applicable)
    • enrollment logs
    • staff signature logs (delegation of responsibility logs)
    • laboratory certifications and normal reference ranges
    • investigator brochures

You can prepare for the review by checking each consent form to ensure that the correct version was used and that it was signed and dated by the subject. If you find a problem with a consent form, note it in the study file and fix the problem as soon as possible (be sure to notify the IRB). Review your regulatory binders and make sure you have all IRB, sponsor, and FDA correspondence in the regulatory file and that the files are in order. Review and update the subject enrollment log (if you have one).

If errors or omissions are discovered, the most frequent advice given is to document the event in the participant’s medical record and place a signed, dated memo regarding the event in the research file (known as “note to file”). A report describing this event should also be submitted to the IRB, along with a plan of corrective action to be taken to eliminate future occurrences. 

When the auditor has completed the review, a findings report is generated and sent to the principal investigator, usually within one to two weeks. The report includes any findings that need to be addressed, corrective actions to be taken, and a time frame by which these actions should be completed. The report also includes recommendations for process improvements. 

When the investigator responds to the report and all the issues have been adequately addressed, the auditor sends a closeout letter and the review is finished. If any instances of serious or continuing noncompliance are found during the review, the auditor brings it to the principal investigator’s attention and immediately works with the principal investigator to address the issue.

On completion of a compliance review or directed investigation, the quality assurance and improvement staff draft a report of the findings and send it to the principal investigator. The principal investigator has two weeks to respond to the issues and to submit a remediation plan to avoid such occurrences in the future. The compliance review report, the principal investigator’s response, and the remediation plan are then presented to the IRB board members.

If there are serious or reportable findings from an onsite review, the report may be distributed to some or all of the following individuals and agencies:

  • department chair
  • vice dean or other institution official
  • regulatory or funding agency

Common deficiencies cited in FDA audits include the following:

  • failure to follow the protocol
  • problems with the Informed Consent Form or the Informed Consent Process
  • failure to keep complete and accurate records
  • failure to account for the disposition of study drug
  • failure to report adverse events