Warning Letter

FDA Clinical Investigator Warning Letter

FDA recently posted a Clinical Investigator warning letter for this trial. Dr. Goodnoy was warned for:

  • Failing to obtain informed consent prior to randomization

  • Subjects were added to IVRS prior to consent and could not be removed from the system when parents would not consent

  • Enrolling subjects who were not eligible

  • Randomizing three subjects to the wrong study arm

  • Administering investigational product that had undergone a 30 minute temperature excursion

  • Failing to perform study required follow up phone calls

  • Three subjects received prohibited concomitant study medications

  • EDC audit trails show that procedures originally entered as not done, and not documented in source records were changed to having been done due to a reason of ‘entry error’.

  • Consent documentation errors, including:

    • Signing consents prior to the subject’s parents signed

    • Failing to retain original documents

    • Changing the time of the consent to appear that consent occurred prior to dosing

FDA Clinical Investigator Warning Letter

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

Dr. Khan was warned for failing to retain records, specifically:

  • IP accountability
  • Informed consents
  • Case histories

FDA notes that the PI misunderstood the record retention requirements to be two years after the termination of the study at the site, as opposed to two years beyond the last marketing application. 

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.

FDA Warning Letter: Entellus Medical

FDA posted a warning letter this week to a device sponsor. 

Entellus Medical was warned for:

  • Failing to secure compliance of noncompliant investigators
    • FDA notes that sponsor employees were present at procedures that did not comply with the approved trial protocol
    • FDA notes that the eighteen pre-planned protocol violations were not reported to FDA
  • Failing to receive FDA and IRB approval prior to implementing a change to the investigational plan
    • FDA states that the pre-planned protocol deviations were encouraged
    • FDA notes that the pre-planned protocol deviations were documented in monitoring visit reports
  • Failing to notify the FDA and IRB of significant new information
    • FDA notes that FDA was notified of the protocol deviation upon submission of the Annual report
    • FDA notes that the IRB was notified after the FDA inspection
  • Failing to submit changes in the investigational plan to the FDA and IRB prior to implementation
    • FDA states that study subjects were placed at an increased risk of harm

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