What is it? Why is it important?

Risk evaluation asks:

  • What is the likelihood that an error occurs?
  • The extent and threshold at which an error can be detected?
  • What impact will an error have on participant safety and data quality?


Risk prioritisation asks:

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

What do I need to do?

As a SP-INV you are responsible to evaluate and prioritise the risks in your study.


Based on a high-, medium-, and low risk scale, evaluate for each identified study risk:

  • The likelihood of its occurrence
  • Its impact on participant safety and the quality of study data


Prioritise your risks:

  • Draw up a REM diagram
  • Prioritise risks according to their position in the REM diagram, with:

1. High risk and high impact – top priority

2. High impact and low risk – medium priority

3. Low impact and high risk – medium priority

4. Low impact and low risk – low priority


Document risk evaluation and prioritisation in a Risk Assessment Form


Irrespective of risk position in the REM, additional individual risk ratings might become necessary in order to decide what resources are most advisable to invest in (e.g. study staff, infrastructure, budget).

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

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
  • SP-INV – Sponsor-Investigator
Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Evaluation and Prioritisation

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): Development ↦ Quality and Risk ↦ Study Risk Management ↦ Risk Evaluation and Prioritisation

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