What is it? Why is it important?
In order to maintain oversight of the risk management of the study, requires that risk reviews including any potential adaptations are documented.
Risk documenation should include:
- Risk implication and the ongoing effectiveness of risk control-measures based on emerging knowledge and expertise
- Which risk control-measures were effective and which one did not work
- The use of automatic triggers and its management (e.g. alarms or technical installations that are triggered once a risk deviates 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 optimising risk management in subsequent studies.
What do I need to do?
- Review all identified study risks
- 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, 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
- 5.0.7 Risk reporting
ISO 31000 (access liable to costs) – see in particular section
- Risk management