What is it? Why is it important?

Risk reviews and potential adaptations must be documented in order to maintain oversight of the risk management of the study.

Information provided include:

  • Risk implication and the ongoing effectiveness of preventative measures based on emerging knowledge and expertise
  • What measures were effective and which one did not work
  • The use of automatic triggers and its management (e.g. risks deviate from predefined quality tolerance limits)
  • Information flow between those implementing risk control measures, and those deciding what control measures to implement.

More

By documenting the ongoing risk management of the study, lessons learned can be used for optimal risk management in subsequent studies.

What do I need to do?

Document the risk management of your study including applicable reviews and their adaptations in the RAT:

  • List all identified study risks
  • Define applicable mitigating strategy
  • Document activities and decisions taken during risk reviews and re-evaluations
  • Include deviations from predefined quality tolerance limits and type of actions taken
  • based on risk, explain how and whether control measures were adapted:
    • With more severe measures
    • With mitigated measures
    • Unchanged as risk remains bellow tolerance limit

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 guidelines

  • 5.0 Quality management
  • 5.0.7 Risk reporting

ISO 31000 – see in particular section

  • Risk management (access liable to costs)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • RAT – Risk Assessment Tool
Conduct ↦ Quality and Risk ↦ Risk Review ↦ Risk Documentation
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 ↦ Quality and Risk ↦ Risk Review ↦ Risk Documentation

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