Series: Helpful Information from BRANY’s Quality Assurance Team Protocol Deviations
A protocol deviation is any temporary alteration/modification to the protocol and other IRB-approved information relating to the research study, such as the consent form, recruitment materials, and questionnaires. While every effort should be made to minimize protocol deviations, they can be unavoidable when dealing with real world circumstances and human participants. After a protocol deviation occurs, it is important to ensure that the protocol deviation is correctly documented. This post by the BRANY QA team is the third installment of common Quality Assurance Review findings for clinical trials – protocol deviations. Protocol deviations are often identified by the monitor and noted on the Interim Monitoring Visit report. Typically, protocol deviations can be major or minor as assessed by the monitor. In our reviews, we tend to see major and minor protocol deviations are not correctly submitted to the IRB. Often, sites are unaware of their IRB reporting requirements and timeframe for submitting major or minor protocol deviations. We recommend checking the SOP for your IRB of record to confirm their protocol deviation reporting requirements. Another common finding we see is when a site disagrees with a protocol deviation cited by the monitor but does not reach out to reconcile the deviation with their monitor. When you receive an Interim Monitoring Visit report, confirm if any protocol deviations are documented. If you disagree with any, contact your monitor immediately to reconcile the deviation. If the monitor agrees to remove the protocol deviation, ensure that communication is filed with the investigator site file. For any protocol deviations you do not disagree with, confirm with the monitor if these are deemed major or minor protocol deviations, and then ensure those are appropriately recorded and reported to the IRB. We recommend utilizing a protocol deviation log to record all protocol deviations.
If you would like further help with assessing compliance around protocol deviation documentation, the BRANY QA team has developed a protocol deviation documentation compliance flowchart. To download the flowchart and other tools developed to aid in compliance checks, please visit https://www.brany.com/forms-and-downloads/.
Any questions? Please reach out to QA@brany.com.
