What is it? Why is it important?

Based on study risk identification, applicable risk control measures were defined to be implemented during study conduct.

Risk review evaluates whether implemented control-measures remain effective and whether new or additional measures are required.

Typical questions asked during risk review:

  • Have new unanticipated risks been identified?
  • Have old risks become less relevant?
  • Are current risk control-measures effective or must they be improved?
  • Are measures still relevant with respect to emerging knowledge and expertise?
  • Is staff appropriately trained?

What do I need to do?

Perform regular risk reviews and:

  • Collect regular staff feedback and re-evaluate the robustness of currently implemented control measures
  • Decide on required adaptations to risk-control measures
  • Keep vigilance regarding deviations from predefined risk tolerance limits
  • Trigger automatic risk reviews:
    • If a risk deviates from predefined quality tolerance limits
    • When implementing new control-measures
  • Schedule regular staff meetings to discuss risk management and train staff accordingly

For more information refer to Quality and Risk in this Study Guide.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0. Quality management

ISO 31000 – see in particular

  • Risk management (access liable to costs)

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 6.2 Risk management
  • 9.1 Clinical Quality management

Swiss Law

HRA – see in particular article

  • Art. 12. Risks and burdens
  • Art. 15. Safety and protective measures

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Risk Review
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Risk Review

Please note: the Easy-GCS tool is currently under construction.