What is it? Why is it important?

The discontinuation or interruption of a study must be notified to 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
  • 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)

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

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

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
Abbreviations
  • 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
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 ↦ Ethics and Laws ↦ Premature Study Termination ↦ ReportingTimelines

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