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Clinical Investigator Disqualification Procedures and Administrative Actions

This guidance outlines the administrative process for disqualifying clinical investigators from participating in studies involving investigational new drugs (including biologics) or devices. It applies when FDA determines that an investigator has repeatedly or deliberately violated regulations or submitted false information to sponsors or FDA.

  1. Implement robust quality management system to ensure compliance with FDA regulations
  2. Maintain accurate and complete documentation of all clinical investigation activities
  3. Establish procedures for responding to FDA inspections
  4. Regularly check FDA’s disqualified investigator list when selecting investigators
  5. Create process for immediate notification to FDA of any significant deviations
  6. Develop protocol for protecting subject safety if study suspension becomes necessary
  7. Establish procedures for reviewing and validating data integrity
  8. Create training program on regulatory requirements for clinical investigators
  9. Maintain communication channels with IRBs and sponsors regarding compliance issues
  10. Document all corrective actions taken in response to identified violations

Key Considerations

Clinical testing

  • FDA conducts on-site inspections to evaluate compliance with regulations
  • Disqualification may occur if:
    • Subjects would be exposed to unreasonable risks
    • Subjects’ rights would be compromised
    • Data integrity is compromised

Safety

  • Studies may be terminated immediately if public health danger exists
  • FDA may allow continued treatment for subjects if suspension creates life-threatening situations

Other considerations

  • No specific ISO or industry standards referenced in this guidance

Original guidance

  • Clinical Investigator Disqualification Procedures and Administrative Actions
  • HTML / PDF
  • Issue date: 2022-12-01
  • Last changed date: 2023-01-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: 4077ba11eedc48a0b590a3f5b3456a38
This post is licensed under CC BY 4.0 by the author.