What is it? Why is it important?

The end of a study must be notified to EC and, if applicable, Swissmedic within:

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

For international studies, study end date corresponds to the date when the last participating study site has ended the study.

What do I need to do?

As SP-INV notify:

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

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

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

ClinO – see in particular article

  • Art. 38 Notification and reporting upon completion, discontinuation or interruption of a clinical trial

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 of a research project
  • Art. 36 Notification requirements
  • Art. 40 Notifications
  • 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
  • FEDLEX – Publication Platform for Federal Laws
  • HRO – Human Research Ordinance
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ ReportingTimelines

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

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
Set-Up Biobanking

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

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): Completion ↦ Ethics and Laws ↦ End of Study Notification ↦ ReportingTimelines

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