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Regulatory Reporting

Definition

• 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).

Policies/guidelines

• 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.

Training

• See the Reportable Events section.