What is it? Why is it important?

Risk evaluation defines, what is the:

  • Likelihood or frequency that a risk or error can occur?
  • Extent and ability to which an error can be detected?
  • Expected impact of an error on participant safety and quality of study results?


Risk prioritisation defines:

  • Based on risk evaluation, how should a risk be prioritised - high-, medium-, low- risk in the study?
  • How will risk-priority affect the requirement of risk control measures?


Based on these criteria the SP-INV is responsible to assess these questions in relation to the study. Thus, risks can subsequently be categorised according to high, medium or low risk.

What do I need to do?

As a SP-INV or Site-INV assess and rank potential risks:

  • In your daily practice, consider the complexity of individual tasks
  • Look for the frequency that an error could occur
  • Estimate its impact on your work, your patients, your institution, your career


Apply the same principles to evaluate potential risks in your study. Use the Risk Evaluation Matrix (REM) to assess risks. Based on risk category, priorities can be set for the implementation of measures needed to mitigate risks.

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
  • REM – Risk Evaluation Matrix
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Quality and Risk ↦ Risk Management Definitions ↦ Risk Evaluation and Prioritisation

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

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

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Quality and Risk ↦ Risk Management Definitions ↦ Risk Evaluation and Prioritisation

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