Study Oversight, Maintenance and Reporting

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Regulatory Reporting


  • Regulatory reporting is addressing the conduct of clinical studies required by laws and regulations to authorities.
  • Regulatory authorities include those authorities that review submitted clinical data and those that conduct inspections (such as the FDA).


  • Federal regulations require prompt reporting to appropriate institutional officials and, as applicable, the federal department or agency for:
    • Any unanticipated problems involving risk to participants or others;
    • Any serious or continuing non-compliance with the applicable federal regulations or the requirements or determinations of the IRB; and
    • Any suspension or termination of IRB approval.