What is it? Why is it important?

During risk reviews control measures are re-evaluated in order to ensure that they remain effective and/or whether new or additional measures are required.

Based on risk review and implemented control measures:

  • 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 study staff up-to-date and trained on current risk control measures?

More

Risk review is an interactive process between those implementing risk control measures, and those deciding what control measures to implement.

Only with a communicative feedback loop can it be guaranteed that quality control measures remain appropriate and effective.

What do I need to do?

Perform regular risk reviews:

  • Collect regular staff feedback and re-evaluate the robustness of current quality 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 study management and train staff accordingly
  • Document the risk review in the Risk Assessment Tool (RAT)

More

Example of a periodic risk review and its re-evaluation process

Protocol requirement: Lab analysis must be performed on fasting blood.

Risk: participants are not fasting

  • 1st Control-measure: participant is informed at study inclusion regarding fasting state at blood draw
  • 1st Periodic risk review: 25% of participants provide no fasting blood
  • 1st Risk re-evaluation: 25% surpasses predefined tolerance limit of 10%. Control measures must be adapted
  • 2nd Adaptation of control measures: Participants are reminded by SMS on the evening before blood draw regarding fasting state at blood draw
  • 2nd Periodic risk review: 13% of participants provide no fasting blood
  • 2nd Risk re-evaluation: 13% acceptable with given conditions. Additional risk control measures are not feasible or too costly if implemented

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
  • 5.0.3 Risk evaluation
  • 5.0.6 Risk review

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)
Abbreviations
  • CTU – Clinical Trials Unit
Conduct ↦ Quality and Risk ↦ Risk Review ↦ Re-Evaluation
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 ↦ Re-Evaluation

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