FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. Dr. Kaplan was cited for:

  • Failing to follow the investigational plan, specifically:
    • Enrolling three ineligible subjects
    • Enrolling a subject who met exclusion criteria between the screening and randomization visit
    • Failing to perform X rays for two subjects after a subject showed symptoms which required X rays as stated in the protocol
    • FDA notes that the PI had delegated the conduct of the study to an independent research organization, but that this did not absolve him of the responsibility of ensuring that the investigational plan was followed