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:
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
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 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