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?

Familiarise yourself with the REM and the way to report risks based on each square.

In particular:

  • Locate risks in the top-right corner of your diagram as they
    • Carry the highest probability of occurrence
    • Have the highest negative impact
  • Give these risks highest priority
  • Define applicable preventative 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

References

ICH GCP E6(R2) – see in particular guideline

  • 5.0 Quality management

ISO 31000 – see in particular section

  • Risk management: Principles and guidelines (access liable to costs)

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • REM – Risk Evaluation Matrix
Basic ↦ Quality and Risk ↦ Risk Management ↦ Risk Evaluation Matrix
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): Basic ↦ Quality and Risk ↦ Risk Management ↦ Risk Evaluation Matrix

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