FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, we can look at the warning letter issued to Dr. Scully. Dr. Scully enrolled subjects into a trial of the Recap Total Resurfacing System sponsored by Biomet and was warned for:
- Failure to follow the investigational plan, specifically:
- Adverse events in four subjects were not reported to the sponsor per protocol requirements, or to the IRB per the IRB approval letter.
- Two subjects received the implant but were lost to follow up. The lost to follow up form was not completed.
- Failure to maintain accurate, current and complete records, specifically:
- Six Harris Hip Score Case Report Forms (CRFs) were not completed for two subjects.
- The source documents for one subject indicated that diabetes medications had been prescribed, however the dose, reason and side effects were not documented.
- Failure to submit required reports, specifically:
- There was no IRB oversight of the study for ten months. The sponsor was not informed of the lack of IRB oversight.