Your Easy Guide to Clinical Studies

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 project must be interrupted.

 

Assessment whether an Adverse Event (AE) is a serious event (SE) is performed according to 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, because 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, additional SEs can be included in the study protocol, or the Ethics Committee (EC.) may request them to be added.

As a Site-INV assess:

• The occurrence of any SEs during the conduct of your research project

 

As a Project-Leader (SP-INV), re-assess the AE, and if confirmed as an SE:

• Immediately interrupt the project
• Report the SE to Ethics Committee (EC) and FOPH (e.g. in the event the project includes the use of a radiation source)

 

In the event the Site-INV 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 should be included in the report.

References

The Declaration of Helsinki – see in particular principle

• 23 Research ethics committee

Swiss Law

HRO – see in particular article

• Art. 21 SE definition and reporting