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FDA

This section includes requirements regarding:

  • Clinical Investigator (individual who conducts the study)
    1. FDA 1572 (drug)
    2. Investigator Agreement (device)
    3. Serious Adverse Event reports submitted to Sponsor
  • Sponsor-Investigator (individual who initiates and conducts the study)
    1. Clinician Investigator requirements 1 or 2
    2. Original application and all subsequent submissions to the FDA:
      • IND Application (drug)
      • IDE Application (device)
      • Amendments to the Application
      • Adverse Event Reports
      • Annual Reports
    3. Form 3674 (Certification of Registration to ClinicalTrials.gov)

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