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