What is it? Why is it important?

The online portal BASEC is the Business Administration System of the Swiss Ethics Committee (e.g. EC-portal).


BASEC is used by researchers to submit documents needed for the approval of clinical studies (e.g. ClinO, ClinO-MD), and non-clinical research project (e.g. HRO projects) based in Switzerland.


The EC-portal is also used by researchers to submit:


In BASEC researchers:

  • Set-up a personal account using a personal login
  • Fill in EC requested study information
  • Upload applicable study documents needed for EC approval

What do I need to do?

As a SP-INV or project leader seeking EC approval:

  • Create a BASEC account with a personal login.
  • Go through the FAQ section, which will greatly facilitate the submission process
  • As applicable, start by establishing a dummy study or project, which helps you to find out which documents to submit (e.g. the same account can be used for multiple submissions)
  • Fill-in all requested study information
  • Upload all study or project required documents


A study or research project can only start after EC has given its approval. Based on study type (e.g. ClinO, ClinO-MD, HRO) and risk-category, approval must also be provided by Swissmedic and the FOPH.

Where can I get help?

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

External Links

Swissethics – see in particular

  • BASEC: EC submission portal

Swiss Law

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
  • HRA – Human Research Act
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Submission Portal ↦ Ethics Portal BASEC

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Submission Portal ↦ Ethics Portal BASEC

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