2/16/2021
Image by Gerd Altmann from Pixabay
During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.
The investigator warning letter was issued due to the site not following the protocol with regards to adhering to 1) inclusion/exclusion criteria, 2) requirements prior to randomization, and 3) completion of certain study activities. The site enrolled subjects that should have been excluded, randomized subjects that were not eligible, and failed to complete some study procedures but yet administered the investigational product. These violations are concerning for subject safety, and they likely would reduce the quality of data collected.
The written response did not outline adequate corrective and preventive actions for the inclusion/exclusion violation. There was no mention about how the investigator will ensure oversight or how they will conduct a root cause analysis to determine the cause of the noncompliance. For the other areas mentioned in the warning letter, it is interesting in that the corrective action was accepted as stated. Part of the corrective action mentioned for each area is to “re-educate the importance of reviewing continuing eligibility criteria before study drug administration.” If the site staff does not understand the importance of such a key component of study conduct, could there be something wrong with the training? Perhaps understanding the root cause of the noncompliance would be more beneficial.
The difference between the violations that had acceptable corrective actions and the inclusion/exclusion violation was the implementation of a Clinical Quality Management Plan (CQMP) added to their site standard operating procedures. A CQMP establishes quality management guidelines and is created to identify and document the processes needed to ensure quality protocol adherence during study conduct. If adequately developed and adhered to, it can ensure quality data and subject safety and help prevent risks before they become further issues.
Need help in working through corrective and preventive action planning or what to do about significant noncompliance in the clinical research setting? Clinical Pathways offers off-the-shelf, interactive eLearning in “Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals”. Interactive demo or purchase information are available HERE. This course as well as “Introduction to Risk Based Quality Management” and “Root Cause Analysis” eLearning are available for customization for use in your LMS or ours, or as live online training for your teams. Email us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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