What is it? Why is it important?

The termination/discontinuation or interruption of a study must be notified to the Ethics Committee (EC), and if applicable Swissmedic within:

  • 90 days, for HRO studies
  • 15 days, for ClinO and ClinO-MD studies
  • 24 hours, for ClinO-MD studies where study termination was due to safety reasons

What do I need to do?

As SP-INV notify:

  • EC by:
    • Submitting a notification form of study discontinuation or interruption via BASEC (e.g. the EC submission portal)
  • Swissmedic by:
    • Completing a “FO submission form” available on the Swissmedic website (e.g. the Swissmedic submission portal)
    • Submitting the document(s) by post, both in paper and electronic form (CD)


With study / research project discontinuation or interruption, provide details and rational as to why the study was stopped.

File notification forms in the TMF.

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 / Template: Notification of the completion or discontinuation of the clinical trial or research project

Swissmedic – see in particular

  • BW101_10_003e procedures to follow once the study is finished, or has been interrupted prematurely
  • FO-template: BW101_10_019e_FO confirmation electronic submission

Swiss Law

ClinO – see in particular articles

  • Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
  • Art. 57 Transplant studies -notifications and reporting
  • Art. 62 Other studies - applicable provisions

ClinO-MD – see in particular article

  • Art. 36 Reporting the conclusion, termination or interruption of a clinical trial

HRO – see in particular article

  • Art. 22 Notification upon completion or discontinuation
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Conduct ↦ Ethics and Laws ↦ Premature Study Termination ↦ ReportingTimelines

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Premature Study Termination ↦ ReportingTimelines

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