Responding to a Compliance Audit Report
The Office of Clinical Research (OCR) conducts periodic compliance reviews of protocols conducted within the Perelman School of Medicine (PSOM). These reviews ensure that clinical research in the PSOM is conducted in compliance with applicable regulations, guidelines, and internal policies and procedures. Any findings or suggestions that result from the review are communicated to the Investigator/Sponsor and the research team before a final Compliance Audit Report (CAR) is issued. CARs with findings that are reportable to the IRB are communicated to the IRB office. It is the Principal Investigator (PI) and study team’s responsibility to submit reportable findings to the IRB for assessment.
When to Submit a CAR finding to the IRB
- If the CAR indicates there are no findings, or all of the findings are not reportable to the IRB, no follow-up with the IRB is required.
- If the CAR has findings that are designated as “reportable to the IRB,” please follow the guidance below.
Unless otherwise directed by IRB staff, findings that are submitted to the IRB should be submitted via a Deviation submission and are subject to reporting timelines and requirements. The reporting timeline begins from the date that the OCR Compliance has accepted the study team’s Corrective and Preventative Action Plan (CAPA) (within 10 business days).
Compliance Audit Reports (CAR) with Reportable Findings
As noted above, CARs with findings that are reportable to the IRB are communicated to the IRB office. The IRB office will review the reportable findings and will communicate with the study team to confirm which findings should be reported in expedited fashion as a deviation versus which may be reported at the next continuing review. The team should work with OCR Compliance to resolve the findings via a Corrective and Preventative Action Plan (CAPA). Once OCR Compliance has accepted the CAPA, the study team should prepare for submission to the IRB.
Principal Investigator Assessment
The PI should review the CAR findings deemed reportable to the IRB and assess each finding against the criteria for serious noncompliance, outlined below. Corrective and preventative actions, based on the identified root cause, to rectify and avoid the error from happening again should also be outlined for the IRB.
Adverse Impact on Welfare of Participants
Assess whether the finding may have potentially had adverse impact on participant welfare. Welfare may be defined as safety, physical integrity, or mental integrity. Assess whether there was potential for harm and whether actual harm occurred. Assess the severity of the potential or actual harm. Write up a response with rationale for the IRB to consider.
Adverse Impact on Rights of Participants
Assess whether any participants rights were violated as a result of the finding. This assessment should also include an assessment of the participant’s willingness to participate and whether they participant is able to be informed of the issue. If the deviation involved consent noncompliance, assess whether re-consent is possible.
Adverse Impact on Scientific Integrity
Assess whether the finding may have an adverse impact on the study results including whether the data collected can be used, the overall scientific value of the trial and/or the reliability of the results. The IRB recommends consultation of a statistician when findings involve substantial missing data.
Frequently Asked Questions
Yes. The IRB has already reviewed the CAR and determined that we need to assess the submission. If the finding did not affect the welfare of participants, the rights of participants, or the scientific integrity of the study, the submission will be acknowledged.
The IRB will direct you if some findings are minor and may be submitted at continuing review in your progress report. Otherwise, you may submit the findings as separate deviations. You may also submit them all in one report by using the CAPA template document. Please do not submit a deviation submission with multiple deviation forms uploaded.
A corrective action is an action taken to correct an error in real-time. For example, a note to file to correct improper documentation is a corrective action. Additionally, re-consenting a participant who was improperly consented is a corrective action. However, neither of these actions will prevent the associated error from happening again in the future.
A preventative action is an action that is taken to prevent an error from happening in the future. For example, retraining staff on proper consent procedures would be considered a preventative action.
An effective CAPA cannot be written without properly identifying the root cause of the error. A root cause is the action or issue that allowed the error to occur. There may be multiple events or issues that led to an error occurring. Conducting a thorough investigation into the error can ensure the root cause has been properly identified.