What is it? Why is it important?
Risk reviews and potential adaptations must be documented in order to maintain oversight of the risk management of the study.
Information provided include:
- Risk implication and the ongoing effectiveness of preventative measures based on emerging knowledge and expertise
- What measures were effective and which one did not work
- The use of automatic triggers and its management (e.g. risks deviate from predefined quality tolerance limits)
- Information flow between those implementing risk control measures, and those deciding what control measures to implement.
By documenting the ongoing risk management of the study, lessons learned can be used for optimal risk management in subsequent studies.
What do I need to do?
Document the risk management of your study including applicable reviews and their adaptations in the RAT:
- List all identified study risks
- Define applicable mitigating strategy
- Document activities and decisions taken during risk reviews and re-evaluations
- Include deviations from predefined quality tolerance limits and type of actions taken
- based on risk, explain how and whether control measures were adapted:
- With more severe measures
- With mitigated measures
- Unchanged as risk remains bellow tolerance limit
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
- 5.0.7 Risk reporting
ISO 31000 – see in particular section
- Risk management (access liable to costs)