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Risk-Based Monitoring of Clinical Investigations

This guidance provides recommendations on risk-based approaches to monitoring clinical investigations of human drug and biological products, medical devices, and combination products. It focuses on planning monitoring approaches, developing monitoring plan content, and addressing/communicating monitoring results.

  1. Develop and document a comprehensive risk assessment methodology
  2. Create a risk-based monitoring plan that includes:
    • Investigation design description
    • Sampling plans
    • Issue escalation procedures
    • Communication protocols
    • Documentation requirements
  3. Implement centralized monitoring capabilities using electronic systems where possible
  4. Establish processes for:
    • Early monitoring visits
    • Regular risk evaluation
    • Documentation of monitoring activities
    • Communication of findings
    • Root cause analysis of issues
    • Corrective and preventive actions
  5. Review and update monitoring plans as new risks are identified
  6. Ensure adequate training of all monitoring personnel
  7. Set up proper documentation systems for monitoring activities and results
  8. Create clear communication channels for sharing monitoring findings with relevant stakeholders

Key Considerations

Clinical testing

  • Monitoring should be a quality control tool to determine if investigation activities are carried out as planned
  • Sponsors must provide oversight and ensure proper monitoring of investigations
  • Early monitoring visits should be considered after first few participants enroll
  • Processes must be in place to maintain appropriate blinding when applicable

Human Factors

  • Consider adequate staffing and training of site personnel
  • Consider participant locations and data collection points
  • Consider experience level of investigators and staff

Software

  • Electronic data capture systems should have capability to assess quality metrics in real-time
  • Consider use of statistical and analytical methods for centralized monitoring

Safety

  • Must ensure protection of rights, safety and welfare of participants
  • System should help identify and track potential risks to participants
  • Significant safety issues must be promptly evaluated and communicated

Other considerations

  • IEC 31010:2019: Risk Management — Risk Assessment Techniques

Original guidance

  • Risk-Based Monitoring of Clinical Investigations
  • HTML / PDF
  • Issue date: 2023-04-12
  • Last changed date: 2024-11-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Drugs, Biologics
  • ReguVirta summary file ID: 0521c008f05329eecac50fa16442a510
This post is licensed under CC BY 4.0 by the author.