FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. 

Dr. Bhatti was warned for the following, after an inspection that ranged over six weeks:

  • Failing to follow the investigational plan, specifically:
    • Enrolling two subjects that did not meet inclusion criteria, due to ECG readings. FDA notes that one subject was enrolled prior to the PI reviewing the ECG, and the subject was subsequently removed from the trial. 
    • Another subject did not meet inclusion criteria due to prior therapy from an earlier trial at the PI's site.
    • A number of missed ECGs on the study, which FDA views as an important safety assessment.
      • One subject missed required ECGs on three study visits.
      • Three subjects missed the week 168 ECG.
      • One subject missed the week 120 ECG. 
      • One subject missed the week 64 ECG.
      • One subject had a week 32 post dose ECG twenty minutes prior to the dose.
      • One subject missed a required post dose ECG at week 32.
  • Failing to retain required records
    • ECG tracings were missing for 15 patient visits. FDA notes that the results were reported in medical records, but the actual tracings could not be located. 
    • One subject questionnaire was not retained at one visit.