The FDA recently posted another Warning Letter for a clinical investigator.
Failure to comply with the investigational plan / protocol.
Failure to maintain case histories (source and CRFs).
So, lessons learned questions:
- How could this have been prevented? From a sponsor's perspective was this a risky site? Did the risk assessment identify this as a potential risk and did the monitoring plan support risk mitigation at the site level?
- What are the root causes?
- What would have been an adequate corrective and preventive action plan from the investigator? The FDA stated twice "your response is inadequate..."
Prevention and effective noncompliance management is critical!