02/01/2022
Photo by Evgeni Tcherkasski on Unsplash
A recent US Food And Drug Administration (FDA) investigator warning letter focused on record retention. According to FDA regulations, site records must be retained for at least two years after a marketing application is approved or two years after the study is closed (21 CFR 312.62(c)). This site did not retain case report forms, signed consent forms, and case histories for many of the study participants involved in a clinical trial whose data was used to support a Biologics License Application (BLA). These documents were lost before the BLA outcome was determined. A CRO monitor discovered the issue of missing documents when they arrived at the site to prepare it for inspection. The site did not provide an adequate corrective and preventive action plan but instead claimed they were transitioning from conducting clinical trials. This is an issue because even if no new records will be created, the site still needs to provide a plan for how to prevent other existing records from being lost or destroyed.
Are you inspection ready? Clinical Pathways can help. We offer inspection readiness and good documentation practices consultations and training.
- The Clinical Pathways Team
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