Quality Improvement and Post Approval Resources

Last updated on June 10, 2016 3 min read Working with Human Subjects - Quality Improvement and Post Approval Resources

To strengthen BU’s human research protection program, the Charles River Campus IRB office has established a Quality Assurance and Improvement (QA/QI) Program. Charles River Campus investigators can learn more below.

Program Objectives

  • Ensure compliance with regulatory requirements
  • Assist investigators in achieving the highest standards while conducting human subject research

On-site Reviews

An important component of the QA/QI Program is the Quality Assurance (QA) Review. The QA Review will assist Principal Investigators and their research staff in ensuring that their research is being conducted in compliance with applicable regulations, laws and institutional policies.

QA/QI review types:

  • Investigator-Requested Review
  • Study Start-Up (after IRB approval and prior to subject enrollment)
  • Review of FDA-regulated research studies
  • Routine Review (studies are randomly selected for review)
  • For-Cause Reviews (requested by the IRB or BU institutional officials)

The QA Review Process

An important component of the QA/QI Program is the Quality Assurance (QA) Review. The goals of the review are to:

  • Identify areas that may be vulnerable to non-compliance with regulatory standards
  • Assist investigators with study management

What to Expect During a Review

The reviews take place at your site and the time involved depends on the complexities of your project. Reviews may take 1-2 hours up to a full day.

The PI does not need to be present during the review, but is encouraged to meet with the QA/QI reviewer before or after the review. If the PI will not be there during the duration of the review, a senior staff member should be available, to answer questions.

The scope of the review may depend on a number of factors including:

  • IRB submissions/documentation
  • Regulatory documentation
  • Compensation records
  • Study binders
  • Subject files

At the conclusion of the review, the QA/QI reviewer will briefly summarize significant findings and recommendations. The QA/QI reviewer will work with the investigator to help resolve/correct problems and discrepancies and will provide recommendations for process improvements. Additionally, a list of required corrective action items will be provided in a written report.

Who Receives the Final Report

A draft of the QA Review report is sent to the PI for review and comment. The PI is invited to discuss the preliminary findings and suggestions for corrective action.

If the review was a For-Cause Review, the finalized report is shared with IRB Committee Members and, if applicable, relevant members of University leadership (Institutional Official, Department Chairs, Deans etc.).

If the review was a PI-Requested Review, the finalized report is typically shared with the PI only. The IRB Committee Members receive aggregate data (not linked to any specific protocols/PIs) on PI-requested reviews.

If unanticipated problems and/or serious and/or non-compliance are identified during the review, the QA/QI reviewer will notify the site and assist them in reporting the event(s) to the IRB. If the site does not report the events in a timely manner, the QA/QI Program is obligated to report to the event(s) to the IRB and to the University’s senior leadership as applicable.

Let us help you identify any areas of potential or current non-compliance and together, let’s correct them. Contact the QI Specialist, Mary McCabe,, to set up your PI-requested study review.

Study Management Tools & Assistance with Study Start-Up

The QA/QI Program has a number of downloadable study management tools & templates to help you.

Assistance with External Audits

The QA/QI Program is available to assist investigators who are undergoing audit by an external agency (FDA, NIH, Sponsors or other outside agencies). The QA/QI Program can assist investigators in preparing for the audit by conducting a review of research records prior to the audit.

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