What is it? Why is it important?

The Ethics Committee (EC) or Regulatory Authorities (RA) such as Swissmedic (i.e. risk-category B and C studies) must be notified of study completion, discontinuation (early termination), or interruption.


A study is:

  • Completed once the last study participant has completed his/her last planned visit (i.e. includes potential follow-up visits)
  • Discontinued when stopped sooner than originally planned. Reasons include:
    • Unexpected safety issues with a negative shift of the study`s risk-benefit ratio
    • The efficacy of the investigational product (IMP/IMD) is better or worse than expected
  • Temporarily Interrupted due to safety issues or concerns (i.e. regarding the risk-benefit ration of the study). The study can continue once safety issues are resolved

What do I need to do?

As a SP-INV, notify EC and if applicable Regulatory Authorities (RA) (e.g. Swissmedic, international) regarding study completion, discontinuation, or interruption.


For Investigational Medicinal Product (ClinO) studies notify:

  • The EC (over BASEC) of study:
    • Completion within 90 days
    • Discontinuation or interruption within 15 days
  • Swissmedic (i.e. risk-category B and C) according to EC timelines


For Investigational Medical Device studies (ClinO-MD) notify:

  • EC (over BASEC) of study:
    • Completion, discontinuation, or interruption within 15 days.
    • Discontinuation or interruption due to safety concerns within 24 hours
  • Swissmedic (i.e. risk-category C) according to EC timelines


As a project leader of an HRO research project notify:

  • The EC of study completion or discontinuation within 90 days


When discontinuing or interrupting a study describe:

  • Reasons
  • Consequences to study evaluation and results
  • How many participants remain in the study (i.e. in Switzerland)



Notification to Swiss authorities is only applicable to studies implemented in Switzerland.

File any confirmation received by EC/RA in the trial master file (TMF) and the investigator site file (ISF) of the study. Also, in the event of multi-centre studies inform participating study sites of study closure (e.g. Site-INVs).

Where can I get help?

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

External Links

Swissethics – see in particular

  • Notification template of the completion or discontinuation of a clinical study or research project 
  • BASEC: EC submission portal 

Swiss Law

ClinO – see in particular article

  • Art. 38 Notification upon completion, discontinuation, or interruption of a study

ClinO-MD – see in particular articles

  • Art. 36 Reporting the end, early termination and interruption of a clinical trial
  • Art. 38 Notification and reporting to Swissmedic

HRO – see in particular article

  • Art. 22, 36, 40, 43 Specifications regarding notification upon completion or discontinuation of a research project
  • 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
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISF – Investigator Site File
  • RA – Regulatory Authority
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Completion ↦ Management ↦ Study Closure ↦ Notification of Closure

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): Completion ↦ Management ↦ Study Closure ↦ Notification of Closure

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