What is it? Why is it important?

The end of a study must be notified to the Ethics Committee (EC) and if applicable Swissmedic (e.g. ClinO risk-category B and C studies; ClinO-MD risk-category C studies).


Timelines are

  • 90 days for ClinO studies
  • 15 days for ClinO-MD studies
  • 90 days for HRO research projects


For international studies with foreign authorities, study end date corresponds to the date when the last participating study site has ended the study (i.e. the last participant has had his/her last study visit).


Even though the study has ended, liability coverage against claims from study participants due to injuries sustained from study participation must remain operational for up to 10 years after study end.


The notification of any sustained injuries must be submitted within three years of becoming aware of the event. Time-barred claims are further defined in the Swiss Code of Obligations.

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. swissmedic submission portal)
    • Submitting the document(s) by post, both in paper and electronic form (CD)


File notification forms in the study TMF.


As a SP-INV and Site-INV, be aware that the liability coverage of your study does not end with the study, but remains valid for a minimum of an additional 10 years.


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: Working instructions Guideline Amendments Clinical Trials
  • FO-template: BW101_10_019e_FO confirmation electronic submission


Declaration of Helsinki – see in particular principle

  • 34 Post-Trial Provisions

SAMS Research with human subjects – see in particular chapter

  • Chapter 9 Respect of participants / liability for damage

MDR 2017 – see in particular intro-points / articles

  • Intro-point 31 Damage claims
  • Intro-point 66 Civil or criminal liability
  • Art. 10 General obligations of manufacturers
  • Art. 69 Damage compensation

Swiss Law

HRA – see in particular article

  • Art. 19 Liability

ClinO – see in particular articles and annex

  • Art. 10-14 Liability and Coverage
  • Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial
  • Annex 2. Policy values for liability coverage

ClinO-MD – see in particular article

  • Art. 3 Applicable provisions
  • Art. 36 Reporting the conclusion, termination or interruption of a clinical trial

HRO – see in particular article

  • Art. 13 Liability coverage
  • Art. 22 Notification upon completion or discontinuation of a research project
  • Art. 36 Notification requirements
  • Art. 40 Notifications

Code of Obligation – see in particular article

  • Art. 60 Claims and time limits

Swiss Code of Obligations:2021 – see in particular article

  • Art. 60 Right to claim damages
  • 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
Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Reporting and Liability

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

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

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ Reporting and Liability

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