What is it? Why is it important?

Prior to study implementation, interventional and observational studies must be submitted to the Ethics Committee (EC) for approval (e.g. interventional studies with IMP/IMD, transplantation studies, stem cell studies, research with deceased persons, and research projects with the further-use of Biological Material (BM) or Health related Personal Data (HrPD)).


An EC review is based on a predefined list of documents submitted by the SP-INV (e.g. the application dossier). The HRA ordinances provide respective itemised lists of required submission documents (e.g. ClinO, ClinO-MD, HRO)


In Swiss multi-centre studies:


In the event a Local-EC does not approve study conduct at a particular site, the Lead-EC:

  • Can only authorise site(s) for study start that have a joint Lead and local-EC(s) approval
  • Will request modifications or additional information in order to allow site study start

What do I need to do?

As a SP-INV, access the swissethics website:

  • Locate the EC responsible for your canton
  • For document submission, go to the BASEC portal and:
    • Register by creating a login account
    • Click on “Submit an application”
    • Enter your study type: IMP, MD, HRO, or other
    • Fill in the form and upload relevant study documents


In the event of a problem or unresolved questions, each EC has a scientific secretarial office that can be contacted for assistance.


EC support might include:

  • The risk-categorisation of your study
  • Submission and processing timelines
  • Administrative concerns
  • Expected EC administrative fees

Where can I get help?

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

External Links

Swissethics – see in particular

  • BASEC: the EC submission portal
  • Ethic committees: a list of all Swiss ECs
  • Templates / Checklists: for PIS, ICF, study protocol

Regional / Cantonal EC – see in particular topics

  • Legal framework
  • Type of project not requiring EC approval
  • Dossier preparation
  • Submission procedures


ICH GCP E6(R2) – see in particular guideline

  • Chapter 3 EC responsibilities, composition, procedures

ISO 14155:2020 Medical device (access liable to cost) – see in particular chapter

  • Chapter 5 Ethical considerations

Swiss Law

HRA – see in particular articles

  • Art. 45-55 EC Role, responsibilities, composition, operations, procedures, records

ClinO – see in particular articles

  • Art. 23 Coordination in authorisation procedures
  • Art. 24 Application
  • Art. 27 Multi-centre trials

ClinO-MD – see in particular articles

  • Art. 9 Coordination in authorisation procedures
  • Art. 10 Application
  • Art. 13 Multi-centre trials

HRO – see in particular articles

  • Art.14 Application
  • Art. 17 Multi-centre projects
  • 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
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – Council for Harmonisation Good Clinical Practice International
  • ICH – International Council for Harmonisation
  • IMP – Investigational Medicinal Product
  • ISO – International Organization for Standardization
  • MD – Medical Device
  • PIS – Participant Information Sheet
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Ethics Application ↦ Submission

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): Development ↦ Ethics and Laws ↦ Ethics Application ↦ Submission

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