Quality Assurance Program

A routine (not-for-case) QA Review is an assessment or examination of a research-related practice or procedure with the possibility (or intention) of instituting change if necessary. Routine QA Reviews of study activities and study documentation are performed on-site as a service to investigators, with feedback provided regarding practices associated with the conduct of the study.

A for-cause (directed) QA Review is an assessment of research or investigators that is initiated at the request of the IRB or the Institutional Official to obtain (or verify) information necessary to ensure compliance with regulations and institutional requirements. A for-cause QA Review is generally based on a concern, complaint, or an allegation that was brought to the attention of the IRB and is used to inform decisions about the conduct of human subjects research and/or human subjects protection.

Studies are randomly identified for routine on-site QA Reviews from the list of all open protocols in the IRB database. Any study involving human subjects may be selected for a routine QA Review. Exceptions to random selection include studies that have received QA Reviews or for-cause reviews within the same calendar year as well as studies closing prior to scheduled review.

The research team (Principal Investigator, Co-investigators, and/or individuals listed in IRBNet) will receive an email notification from the QA staff indicating that a particular IRB protocol has been selected for a QA Review. The QA staff will arrange a mutually agreeable appointment for an on-site or virtual review, typically within 2-4 weeks of notification.

QA Reviews can take place on-site or virtually. After reviewing the protocol records, QA staff will determine whether an on-site or virtual visit is most appropriate.

The QA Review will involve an internal records review, a brief interview with a few members of the research team, and a possible on-site visit.

If selected for an on-site visit, it will consist of two parts: (1) An on-site records review of all protocol documentation and (2) a tour of the research facility. 
 

QA staff will ask that specific IRB-related records are available for review. Examples include:

• IRB-approved documents, including initial, continuing, and amendment reviews.
• IRB-related correspondence, including IRB approval letters.
• Informed consent documents.
• Screening/enrollment lists used to identify potential participants.
• Sponsor correspondence.
• Reports of unanticipated problems and adverse events.
• Drug and device accountability records.

The QA staff may ask questions regarding the research team, protocol procedures, recruitment, the consent process, record keeping, adverse events, or other questions specific to the protocol.

QA Reviews typically last no more than one hour. If additional time is required, QA staff will notify the investigators as soon as possible.

QA staff will provide the research team with a written report via email, no later than one week following the audit.  The Principal Investigator is expected to review the report and return a signed copy within 10 business days.

The results of the QA Review will be shared with all members of the research team.  The results will also be reviewed by the IRB Chair and the IRB Committee at the monthly Full Board Meeting. 

To prepare for a QA Review, ensure that all IRB-related materials are well-organized and readily available for the QA staff. You can use the checklists below as a guide:

Quality Assurance Checklist for Investigators

Virtual - Quality Assurance Checklist for Investigators

Also, please be sure to check the CITI Human Subject Research records for all team members to ensure that all training records are up-to-date.

If problems are identified, please contact the IRB Office immediately. 

Depending on the severity of the issue, a deviation report and/or problem report may be required.