What is it? Why is it important?

A Serious Event (SE) is an AE where it cannot be excluded that the event is attributable to the research project (e.g. projects that involve the sampling of biological material, collection of health-related personal data), and which:

  • Requires extension of a current hospital stay or inpatient treatment not foreseen in the study protocol
  • Results in permanent or significant incapacity or disability; or
  • Is life-threatening or results in death

Apart from this list and in order to ensure participant safety, EC can define additional SEs that must be followed and documented. These are either added to the study protocol, or become requested during study conduct.

What do I need to do?

As a Project Leader (e.g. also named project sponsor):

  • In the event of an SE occurrence during study conduct, immediately interrupt the study
  • Inform potentially involved sites to stop the study
  • Report the SE to EC (via BASEC):
    • Within 7 days of awareness
    • Include an SE assessment (e.g. causality)
    • Include a proposal for modification, continuation or termination of the research project
  • For research projects involving radiation, report the SE to the FOPH (e.g. the FOPH has delivered an opinion regarding study safety):
    • Within 7 days of awareness

The EC has 30 days to reach a decision regarding the safe continuation of the research project.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Templates and checklists / Notifications
    • Notification of serious events (SE)

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
  • BASEC - Business Administration System for Ethics Committees
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • HRO - Human Research with the Exception of Clinical Trials
  • SE – Serious Event
Conduct ↦ Safety ↦ Research Project Safety Reporting ↦ Serious Events
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 ↦ Research Project Safety Reporting ↦ Serious Events

Please note: the Easy-GCS tool is currently under construction.