Your Easy Guide to Clinical Studies

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?

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).

References

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

Documents

• Risk Assessment Form for Clinical Research Projects