FDA Clinical Investigator Warning Letter

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is a clinical investigator warning letter issued in 2008.

Dr. Holub was warned for:

  • Failing to supervise the investigation
  • Failing to conduct the investigation according to the investigational plan, specifically:
    • Failure to assign subject screening numbers in compliance with the protocol
    • Failure to perform required screening assessments, including imaging
    • Enrolling a subject taking a prohibited concomitant medication
    • Failing to ensure that study personnel who were administering consent, dispensing study drug and determining eligibility were listed on the FDA Form 1572
  • Failing to maintain adequate records of investigational product, specifically:
    • Failing to distribute drug in compliance with subject randomization
  • Failure to ensure proper informed consent
    • Data was collected for one subject at a screening visit months before signing the IRB approved informed consent
    • Data was collected for another subject at a screening visit for another trial and used for the current trial. The subject did not sign the informed consent for the current trial until two months after data collection.
    • Another subject's consent form could not be located. The caregiver for the subject (this was an Alzhimer's trial) could not recall that the subject ever signed a consent.
  • Failure to retain required documents
    • FDA cites two missing consent forms
  • Failure to retain adequate and accurate case histories
    • Four missing case report forms
    • One subject was misidentified on a lab report

FDA notes that Dr. Holub indicated that the deficiencies were due to clinical research coordinators; FDA notes that it was the investigator's responsibility to oversee the trial.