What is it? Why is it important?
Risk evaluation asks, what is the:
- Likelihood or frequency that a risk or error can occur?
- Extent and ability to which an error can be detected?
- Expected impact of an error on participant safety and quality of study results?
Risk prioritisation asks:
- Based on risk evaluation, how should a risk be prioritised - high-, medium-, low- risk to the study?
- How will risk-priority affect the requirement of preventative measures?
Based on these criteria the SP-INV is responsible to assess these questions in relation to the study. Thus, risks can subsequently be categorised according to high, medium or low risk.
What do I need to do?
Assess and rank potential risks:
- In your daily practice, consider the complexity of individual tasks
- Look for the frequency that an error could occur
- Estimate its impact on your work, your patients, your institution, your career
Apply the same principles to evaluate potential risks in your study. Use the REM to assess risks. Based on risk category, priorities can be set for the implementation of measures needed to mitigate risks.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.0.3 Risk evaluation
- 5.0.6 Risk review
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)