What is it? Why is it important?

The Business Administration System for Ethics Committees (BASEC) is the EC portal for the submission of all clinical studies and non-clinical research projects in Switzerland:

  • Clinical trials
  • Research projects
  • Amendments
  • Notification of safety events
  • Clarification of responsibilities
  • Requests for temporary authorizations
  • General questions, etc.

The submission process contains a series of screens to be filled in and documents to be uploaded.

What do I need to do?

As a SP-INV or project-leader submit your study or project (as defined under HRA) prior to implementation to EC for approval.

When planning to submit a study or research project:

  • Create a personalised account
  • Go through the FAQ section, which can greatly facilitate your submission

The same account can be used for multiple study submissions of different projects.

Create a dummy project via your account which allows you to find out which documents are required for your trial or research project.

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

Swissethics – see in particular

  • BASEC: EC submission portal

Swiss Law

FEDLEX – law are available online under number

  • 810.308 HRA

HRA – see in particular article

  • Art. 56a Cantonal information system
  • BASEC – Business Administration System for Ethics Committees
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FAQ – Frequently Asked Questions
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Portals ↦ Ethics Portal BASEC

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): Basic ↦ Ethics and Laws ↦ Portals ↦ Ethics Portal BASEC

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