What is it? Why is it important?
Depending on role, responsibilities and involvement in the study, study team members:
- 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 problems in the study conduct. To pre-empt stock outs she may propose a weekly shipment instead.
What do I need to do?
Based on delegated tasks SP-INV ensures that staff members:
- Are familiar with their individual roles and responsibilities and are accordingly trained
- Implement study risk management activities
- Provide feedback on the risk-based QMS of the study, such as
- Ongoing risk surveillance
- Feasibility including required adaptations of mitigating measures
- Inform about newly identified risks and propose potential mitigating measures
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 guideline
- 5.0 Quality management
ISO 31000 – see in particular section
- Risk management: Principles and guidelines (access liable to costs)