What is it? Why is it important?

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


Questions to ask during a risk review:

  • Have new unanticipated risks been identified?
  • Have old risks become less relevant?
  • Do current risk control-measures remain effective or must they be replaced or improved?
  • Are risk-control measures still relevant with respect to emerging knowledge and experience?
  • Are delegated tasks distributed among study staff members, regarding risk control-measures, up-to-date and trained?


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

Only with periodic risk reviews, and a communicative feedback loop, can it be guaranteed that quality control-measures remain appropriate and effective.

What do I need to do?

As a SP-INV or Site-INV implementing a risk strategy for your study, perform regular risk reviews:

  • Collect regular staff feedback and re-evaluate the robustness of current Quality Control (QC) measures (e.g. monitoring, process verification and training)
  • Decide whether risk control-measures must be adapted, improved, or even deleted 
  • 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 risk control-measures
  • Schedule regular study staff meetings to discuss the risk management of the study and train staff accordingly
  • Document the risk review in the Risk Assessment Form (RAF)


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

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

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


ICH GCP E6(R2) – see in particular guidelines

  • 5.0 Quality management
  • 5.0.3 Risk evaluation
  • 5.0.6 Risk review

ISO 31000 (access liable to costs) – see in particular section

  • Risk management: Principles and guidelines


  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • QC – Quality Control
  • RAF – Risk Assessment Form
  • Site-INV – Site-Investigator
  • SMS – Short Message Service
  • SP-INV – Sponsor-Investigator
Conduct ↦ Quality and Risk ↦ Risk Review ↦ Re-Evaluation

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Quality and Risk ↦ Risk Review ↦ Re-Evaluation

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