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Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies (DRAFT)

This guidance clarifies safety reporting requirements and responsibilities for clinical investigators conducting studies under Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs). It provides recommendations to help investigators identify and report safety information that requires prompt reporting to sponsors and Institutional Review Boards (IRBs).

This is a draft guidance. Not for implementation.

  1. Establish procedures to immediately report SAEs to sponsors (within 1 calendar day recommended)
  2. Implement a process to assess causality between adverse events and investigational products
  3. Create a system to track and report non-serious adverse events according to protocol timelines
  4. Develop procedures to identify and report unanticipated problems to IRBs
  5. For IDE studies:
    • Set up UADE reporting process within 10 working days
    • Prepare annual progress reports
  6. Document agreements with sponsors regarding IND safety report submissions to IRBs
  7. Review and maintain familiarity with IRB procedures for safety reporting
  8. Maintain records of all safety reports and communications with sponsors and IRBs
  9. Establish training for study team members on safety reporting requirements and procedures
  10. Implement quality control measures to ensure compliance with reporting timelines and requirements

Key Considerations

Clinical testing

  • Investigators must immediately report any Serious Adverse Events (SAEs) to sponsors, regardless of causality assessment
  • Study endpoints that are SAEs must be reported according to protocol unless there is evidence suggesting causal relationship with the drug
  • For IDE studies, investigators must report Unanticipated Adverse Device Effects (UADEs) within 10 working days

Safety

  • Investigators must assess causality between adverse events and investigational product
  • Non-serious adverse events must be reported according to protocol timelines
  • Investigators must report unanticipated problems involving risk to human subjects to IRBs
  • For IDE studies, progress reports must be provided at least yearly

Other considerations

  • 21 CFR 312: Investigational New Drug Application
  • 21 CFR 812: Investigational Device Exemptions
  • 21 CFR 56: Institutional Review Boards

Original guidance

  • Safety Reporting Requirements for Clinical Investigators in IND and IDE Studies
  • HTML / PDF
  • Issue date: 2021-09-29
  • Last changed date: 2021-09-29
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Device & Drug Safety, Drugs, Biologics
  • ReguVirta summary file ID: 34937dd2a336bbc236bbc8a1fb9ec7b6
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