What is it? Why is it important?

The Swissmedic portal allows access to the various eGov services of Swissmedic. It offers a secure electronic communication platform between study investigators and Swissmedic.

In Switzerland, the portal service eSubmissions is the electronic tool for the submission of clinical studies with MDs and standardized transplants

What do I need to do?

To use the portal, you must sign a user agreement with Swissmedic.

When planning MD or transplant studies, ask a user administrator or an account administrator at your institution to help you with the creation of a user account.

Where can I get help?

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

Experienced staff at your local CTU can provide you with support on this topic

External Links

Swissmedic – see in particular

  • BW101_10_004e_AA Guideline Clinical Trial Application Dossier (Selection: Clinical Trial Application – document)
  • Selection: medical devices / clinical trials / how to submit?
  • eGov Service eSubmission
Abbreviations
  • CTU – Clinical Trials Unit
  • MD – Medical Device
Basic ↦ Ethics and Laws ↦ Portals ↦ Swissmedic Portal
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): Basic ↦ Ethics and Laws ↦ Portals ↦ Swissmedic Portal

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