What is it? Why is it important?

Depending on study type, closing the study requires that respective institutions are notified.

For ClinO studies, the SP-INV notifies:

  • The EC over BASEC of any study:
    • Completion within 90 days
    • Discontinuation or interruption within 15 days. Include reasons for study closure
  • Swissmedic for category B and C studies. Timelines are identical to the EC timelines.

For HRO projects, the project leader notifies:

  • The EC of study completion or discontinuation within 90 days

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

What do I need to do?

Notify applicable authorities regarding study completion, discontinuation or interruption.

File any confirmation received by EC and RA in the trial master file (TMF) and the investigator site file (ISF) of the study. Also Inform participating study sites of study closure.

For more information refer to Ethics and Laws in this Study Guide.

Where can I get help?

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

External Links

Swissethics – in particular see template

  • Notification of the end, discontinuation or interruption of a clinical study

BASEC: submission portal to the EC.

Swiss Law

ClinO – see in particular article

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

HRO – see in particular article

  • Art. 22, 36, 40, 43. Specifications regarding notification upon completion or discontinuation of a research project
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethic Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Completion ↦ Management ↦ Study Closure ↦ Notification of Closure
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): Completion ↦ Management ↦ Study Closure ↦ Notification of Closure

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