FAQs – Quality Assurance Reviews
One of the primary activities of the Quality Assurance program is to conduct Quality Assurance (QA) reviews of selected IRB approved research studies. If you have received a notice informing you that your study has been chosen to receive a QA review, you may have several questions that hopefully, will be answered in the FAQs that follow:
1. Is this an audit?
QA reviews are similar to an audit in that the reviews are systematic and their purpose is to determine if the conduct complies with regulatory and policy standards. QA reviews are not performed in response to a concern or complaint. Instead, QA reviews are done for any study that has been recently IRB-approved and meets the criteria for conducting a QA review. QA reviews are intended to be done quickly and to provide a quick “snapshot” overview of the study’s compliance with regulations, policies, and best practice guidance.
2. Why was my study selected? (Did I do something wrong?)
No, you didn’t do anything wrong to cause your study to be selected for a review. The study was simply chosen from a list of recently approved protocols. Any study can be chosen, but the emphasis is on those studies that are greater than minimal risk, investigator-initiated and interventional. We try to identify studies shortly after IRB-approval, with at least a few subjects enrolled so that any issues that need to be corrected are identified early in the conduct of the study.
3. My study has an outside sponsor who sends a monitor to do this kind of activity…. do I really need another?
Yes. The sponsor has a monitoring plan in place to ensure compliance with its regulatory requirements to ensure that the study conduct at sites follows the approved protocol. Likewise, BMC and BU Medical Campus have an obligation to implement quality assurance measures to ensure that human research conducted at BMC/BU Medical Campus adheres to applicable regulations, institutional policies, and best practices to ensure that the rights and welfare of study participants are protected, and that the study data resulting from the study are reliable and valid.
4. What is the purpose of this review?
QA reviews are performed by the BMC/BU Medical Campus Office of Human Research Affairs (OHRA) to ensure that the rights and welfare of study participants are protected. Quality assurance reviews of new and on-going research studies ensure that IRB-approved research studies are conducted in compliance with applicable regulations, policies and guidance. The reviews are intended to be educational and consultative in nature. The goal is to identify and help correct potential problems in study conduct, documentation, or process before they affect safety of participants and/or validity/integrity of study data.
5. What does the QA review entail?
The onsite review primarily consists of review of the study records (both hardcopy and electronic). This would typically include such documents as the original signed informed consent forms, subject eligibility assessments, study visit activities, compliance with the IRB approved confidentiality plan and the data safety monitoring plan and staff qualifications, training and delegation of responsibilities. Other aspects of the study may also be reviewed as needed.
6. How much time will be required from me?
Most on-site reviews are completed in less than four hours during a single visit. Additional visits may also be needed. The study PI does not have to be present while the inspection is underway as long as someone from the study is available to answer any questions that may come up and provide access to the necessary documents.
7. What do I need to do to get ready for the review?
You should make sure that the relevant documents (hardcopy and electronic) to assess your study are available to the QA reviewer. Beyond this, you don’t need to do anything in advance to prepare for this review. The best approach to present your study records for review “as-is.” That way, should any previously unknown problems be found, they can be brought to your attention for follow-up, reporting (if applicable), and corrective action.
8. How will I find out what the results of the review are?
Once the onsite review is completed, a report will be provided to you detailing the review findings/observations and recommendations. If the review identifies any protocol deviations which have not already been reported to the IRB, these will be noted in the report for follow-up and reporting by the PI. Review reports are sent by e-mail to the PI within 1 week of completing the on-site review of study records.
9. Are the review findings shared with any other office/department?
The report is provided to the PI of the study, BMC/BU Medical Campus Human Research Protection Program (HRPP), and the BMC Research Compliance Officer. The PI is responsible for reporting to the IRB in compliance with IRB policies and procedures. Major deviations must be submitted along with a corrective action plan (CAP) to the IRB within 5 days of the study team being aware of the deviation(s). Minor deviations must be documented, tracked and submitted in aggregate at the time of continuing review.
These questions are the ones that we hear most often about the QA review program, but you may have additional questions that you would like to get answers to. If so, please feel free to contact an OHRA Human Research Quality Manager and he or she will be happy to provide you with the information you are seeking.
And don’t forget, investigators may also proactively request a QA review at any time during the course of the study; it isn’t necessary to wait to be selected!