What is it? Why is it important?

The Risk Evaluation Matrix (REM) is a function graph with a schematic representation regarding the expected risk and its:

x-axis: Probability of risk occurrence

y-axis: Expected impact on the study


  • Based on risk probability and impact, an evaluation is made which is represented by a number with: 1=low, 2=medium, 3=high
  • Risks located on the top right-hand corner of the diagram are given highest priority (total score = 9), as they are expected to occur with high probability and have a high impact

What do I need to do?

As a SP-INV or Site-INV familiarise yourself with the REM diagram and how to manage risks based on their assessed location in the REM.


In particular locate risks on the top-right corner of your RAM diagram, and:

  • Give these risks highest priority, as they carry the highest probability of occurrence and have the highest negative impact
  • Define applicable risk control measures in order to control or avoid their occurrence and as a consequence their negative impact on the study

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guideline

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

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Quality and Risk ↦ Risk Management Definitions ↦ Risk Evaluation Matrix

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