03/15/2022
Photo by S O C I A L . C U T on Unsplash
In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.
The site’s corrective and preventive actions focused on the study participants and the site staff, such as notification to the participants with documentation, calendars, monthly staff meetings, and an SOP for IRB workflow. The FDA stated the plans were not evaluable since they did not include corrective or preventive actions for the investigator. Since it is a regulatory requirement for the investigator to oversee the clinical trial at the site and ensure that an IRB is continuing review of the trial, additional steps are needed to describe how the investigator will prevent the violation from reoccurring.
The warning letter is concerning because without appropriate ongoing IRB review, it is uncertain that the safety and rights of study participants are protected. Consequently, the quality of the trial results may be questioned. An interesting note is that the warning letter is listed on FDA’s website as IRB rather than investigator. The FDA specifically notes in the warning letter that it is not the IRB’s responsibility, but the investigator’s, to ensure IRB continuing review and approval.
Looking for an affordable, online, GCP curriculum? Clinical Pathways offers eLearning through our online store HERE. Ask us about enterprise options.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.