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FDA Sponsor-Investigator Warning Letter

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

Dr. Burt was warned for:

  • Failing to ensure that the study was conducted in accordance with the investigational plan in the IND, specifically:
    • Failing to report Grade 3 adverse events in two subjects at one site to FDA in annual reports, as required by the protocol.
    • Failing to ensure four sites reported adverse events, as required by the protocol. FDA notes that there was no adverse event CRF designed for the study.
    • Failing to report two deaths on study to the FDA as required by the protocol.
    • Failing to review three adverse events during the course of the study to determine if they required reporting to FDA
    • Failing to conduct the interim analyses required by the protocol.
  • Failing to submit a protocol amendment to the IRB
    • The protocol was amended when new investigators were added to the study, but these three protocol amendments were not submitted to FDA
    • A total of nine protocol amendments were not submitted to FDA
  • Failing to select qualified investigators
    • The sponsor investigator was unaware of the training and qualifications of one site and eventually that one site was suspended from the trial for enrolling ineligible subjects.
    • The stated selection criteria for three other sites was "knowledge of professional reputation"
  • Failing to obtain CVs, Financial disclosure and FDA 1572s from participating sites.
  • Failing to provide an investigator brochure.
  • Failing to monitor study progress
    • No onsite monitoring was performed
    • There was no evidence of other types of monitoring
  • Failing to submit annual reports
  • Failing to review adverse events at his own site, as required by the protocol.
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