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

More

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

References

The Declaration of Helsinki – see in particular principle

  • 23 Research ethics committee

Swiss Law

FEDLEX – law is available online under number

  • 810.301 HRO

HRO – see in particular article

  • Art. 21 SE definition and reporting
Abbreviations
  • AE – Adverse Event
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • FEDLEX – Publication Platform for Federal Laws
  • HRO – Human Research with the Exception of Clinical Trials
  • SE – Serious Event
Conduct ↦ Safety ↦ Safety Assessment ↦ Research Projects
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Safety ↦ Safety Assessment ↦ Research Projects

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