What is it? Why is it important?
The SP-INV and Site-INV are responsible for the ongoing safety of their study participants, including study staff. They must ensure that risk control measures remain effective and that new potential risks are promptly identified. This can only be achieved through the execution of selective risk reviews.
Questions to address during study conduct include:
- Have any new risks been identified that were initially not anticipated?
- Have old risks become less or more relevant due to new situations or insight?
- Are current risk control measures effective or must they be improved?
- Are risk control measures still relevant with respect to emerging knowledge and expertise?
- Is study staff up-to-date and trained on current study risks including implemented control measures?
Risk reviews are interactive processes between those implementing risk control measures, and those deciding which control measures to implement. Only through this communicative feedback loop can it be guaranteed that risk measures remain appropriate and effective.
What do I need to do?
As a SP-INV:
- Re-evaluate any study risks and preventative measures defined at study start
- Identify any new potential study risks, including changes to existing risks
- Ensure that implemented preventative measures remain relevant
- As required, perform or update the risk-benefit assessment of your study. If applicable, implement required steps
- Document the risk review and include any adaptations or implemented changes to your risk strategy
As a Site-INV:
- Ensure staff is trained on study risks, defined control measures, including potential adaptations
- Stay in ongoing contact with the SP-INV of the study regarding safety management and concerns
For more information refer to Quality and Risk in this Study Guide.
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
Swissmedic – see in particular information sheets
- BM101_10_002e_MB FAQ on clinical trials with medicinal products
- BW101_10_003e_AA Instruction for reporting during the course of a study
- MU680_20_004e_MB Medical devices FAQs patients
ICH GCP E6(R2) – see in particular guidelines
- 5.0 Quality management
- 5.0.3 Risk evaluation
- 5.0.6 Risk review
ISO 14155:2020 Medical device (access liable to cost) – see in particular section
ISO 31000:2018 Risk management (access liable to cost) – see in particular section