What is it? Why is it important?
During study conduct, the safety of study participants must be guaranteed at all times. Based on the safety laws, human studies:
- Can only be carried out if equivalent findings cannot be obtained through other means
- Must ensure that risks and burdens are minimised
- Must ensure that risks and burdens are not disproportionate to any expected benefits (e.g. risk-benefit ratio)
- Participant safety is constantly monitored (e.g. safety risk review)
- Safety events are assessed and reported to EC/RA on an ongoing and timely required manner (e.g. safety reporting)
- The risk-benefit ratio of the study is constantly monitored in order to remain acceptable (e.g. benefits outweigh risks)
- The study is immediately stopped once safety can no longer be guaranteed
The risk-benefit assessment of an ongoing study requires that physical, psychological, and social risks are included in the evaluation. All aspects considered the potential individual benefit for participants must outweigh any identified risks.
What do I need to do?
- Laws and guidelines applicable to your study
- Procedures described in the study protocol, safety monitoring plan, including applicable local SOPs / WIs
- Delegated responsibilities (e.g. data safety monitoring board) and reporting procedures (e.g. to EC and Swissmedic, from Site-INV to SP-INV)
- Training requirements for study staff
As a SP-INV:
- Set-up a risk-based Quality Management System (risk-based QMS) for your study
- Assess the risk-benefit ratio of the study on an ongoing basis. Implement as applicable risk preventative measures
- Immediately stop the study if participant safety can no longer be guaranteed
For more information refer to Safety and QM & Risk in this Study Guide.
Safety monitoring is a dynamic process. At any time during study conduct, can new and unexpected safety issues become apparent. In the event of new safety concerns, study participants must be informed on how this might affect their safety (e.g. orally and in writing such as a PIS). A protocol safety amendment might require that the Informed Consent Form (ICF) be adapted. In that case, participants are asked whether they want to stay in the study, and if so they are requested to re-consent to study participation (e.g. participant sign and date the updated ICF document).
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
Declaration of Helsinki – see in particular principles
- 4 Safety
- 7-9 Protection of rights, health and interest
- 14 Medical research and medical care
- 16-18 Risks, burdens and benefits
ISO 14155:2020 Medical device (access liable to costs) – see in particular sections
- 4 Summary of GCP principles
- 6.2 Risk management
- 7.4.4 Risk assessment process for potentially unacceptable risks
SAMS manual “Research with human subjects” – see in particular chapters
- Chapter 4 Scientific requirements
- Chapter 6 Assessment of risk and benefits
HRA – see in particular article
- Art. 15 Safety and protective measures