Conduct↦Safety↦Safety Assessment↦Research Projects
What is it? Why is it important?
Safety assessment (SA) is a standardised procedure used to evaluate, among others, Serious Events (SEs) during the conduct of research projects.
If in the course of a research project, serious events (SE) occur in participants, the study must be interrupted.
Assessment whether an Adverse Event (AE) is a serious event (SE) is based on 2 main criteria:
- Causality: where it cannot be excluded that the AE is attributable to the sampling of biological material or the collection of health-related personal data
- Seriousness where the AE is serious if the AE:
- Requires inpatient treatment not envisaged in the protocol or extends a current hospital stay
- Results in permanent or significant incapacity or disability, or
- Is life-threatening or results in death
In order to guarantee participant safety and health, additional SEs can be defined and included in the study protocol, or based on a request forwarded by the EC.
What do I need to do?
As a Site-Researcher assess:
- The occurrence of any SEs during the conduct of your research project
As a Project-Leader, re-assess the AE, and if confirmed as an SE:
- Immediately interrupt the project
- Report the SE to EC and FOPH (e.g. in the event the project includes the use of a radiation source)
In the event the Site-Researcher and the Project-Leader disagree on the assessment, they should try to find a consensus. If not possible, the opinion of both Site-Researcher and Project-Leader (Sponsor) should be included in the report.
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
The Declaration of Helsinki – see in particular principle
- 23 Research ethics committee
HRO – see in particular article
- Art. 21 SE definition and reporting