What is it? Why is it important?
- Provide feed-back regarding risk identification
- Evaluate risks and propose applicable risk control measures
- Ensure that risk control measures are correctly implemented
- Provide feedback in the event risk prevention measures do not provide adequate protection against risk occurrence
A nurse at a study site identifies regular delays with monthly drug shipments, causing potential risks in study conduct (e.g. participant recruitment, interruption in study drug treatment). To pre-empt stock outs she proposes risk-control measures by implementing weekly shipments instead.
What do I need to do?
- Are familiar with their delegated roles and responsibilities (e.g. documented in the delegation-log)
- Have the required education and training
- Implement the defined risk-strategy of the study (e.g. risk-control-measures, risk review)
- Provide ongoing feedback on the:
- Ongoing risk surveillance during study conduct
- Applicability of implemented risk-control-measures including required adaptations
- Identification of novel risks and the proposition of mitigating measures
- Are trained on QMS and risk management procedures, including the filing of study essential documents (e.g. ISF/TMF)
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 guideline
- 5.0 Quality management
ISO 31000 (access liable to costs) – see in particular section
- Risk management: Principles and guidelines