Basic↦Quality and Risk↦Risk Management Definitions↦Risk Evaluation Matrix
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 preventive 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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)