FDA Clinical Investigator Warning Letter

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the warning letter issued to a Clinical Investigator.

Dr. Fandino was warned for:

  • Failing to personally supervise a clinical investigation.
  • Failing to follow the investigational plan, specifically:
    • Enrolling subjects who had been diagnosed with diabetes greater than 5 years ago, contrary to protocol requirements. FDA notes that 40% of subjects enrolled at site were ineligible due to this error by the site.
    • Enrolling subjects who did not meet the protocol requirements for stable dosing of a morphine equivalent, due to errors in calculating the morphine equivalent
  • Failing to prevent the theft of an investigational product subject to the Controlled Substances Act. FDA notes that investigational product was stored in an unlocked and unsecured room, and that according to a police report, 900 tablets were stolen. 

FDA specifically notes concerns with one of the the Principal Investigator's Standard Operating Procedures (SOPs) submitted in response to these issues, where the study coordinator is assigned responsibility for drafting the source documents and CRFs for a study, with the PI editing and reviewing these documents. FDA states that this approach raises questions about principal investigator oversight.