FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. Dr. Liao was warned for:

  • Failing to follow the investigational plan, specifically:
    • Enrolling an ineligible subject (no measurable tumor at baseline)
    • Failing to conduct required laboratory tests at follow up visits
    • Failing to conduct follow up imaging at required intervals
    • FDA notes that they do not accept the PI's perspective that due to the subject's disease state these tests were unnecessary 
  • Failure to maintain adequate and accurate case histories, specifically:
    • Failing to document prior rounds of therapy adequately
    • Failing to document that lab tests for two subjects at screening met inclusion criteria
    • FDA notes that they do not accept that some of these records may have been misplaced and that the PI would try to locate them
  • Failure to maintain adequate records of drug disposition
    • FDA notes that they do not accept the PI's calculations of what subjects would have received