What is it? Why is it important?

In order to receive study approval the SP-INV submits an application dossier to the Ethics Committee (EC).


The dossier contains among others:

  • A cover letter
  • The study protocol
  • The Participant Information Sheet (PIS) and informed Consent Form (ICF), including any materials distributed to participants (e.g. advertisements, questionnaires)
  • A list of study variables to be collected (e.g. or the study CRF, which shows the set-up of the study database)
  • The CV of the SP-INV
  • Relevant contract(s)
  • Insurance certificate (HRO risk-category A projects do not require insurance)
  • The GCP certificate of the SP-INV (only for ClinO / ClinO-MD studies)


The EC may also request:

  • Participant reimbursement policies
  • Text for advertisement purposes
  • Study SOPs
  • Ionising radiation authorisations
  • The monitoring plan (only ClinO / ClinO-MD studies, in some cases HRO studies)
  • Applicable transfer agreements: 
    • Material Transfer Agreement (MTA) for sharing Biological Material (BM)
    • Data Transfer Agreement (DTA) for sharing Health related personal data
  • Proof of participant death for studies with deceased persons


Some institutions might be able to support you with the compilation of the application dossier and its EC submission. Check applicable services or contact your local CTU.

What do I need to do?

As a SP-INV, prepare your EC application dossier. The EC will:

  • Only view your application dossier once all the required documents have been uploaded on BASEC (e.g. the EC submission portal)
  • Acknowledge the receipt of your dossier within 7 days, and 10 days for studies with Investigational Medical Devices (IMDs)
  • Inform about missing or incomplete documents, including related deadlines


Once complete, the EC will process the application dossier within:


EC can request additional information from the SP-INV and/or Site-INV. This extends the processing timeline, as the clock is stopped until all required information is received.


For ClinO-MD studies, the deadline to submit additionally requested information is 10 days. If the deadline is not met, the application will not be admitted.


You can start your study once EC approval is received. In some instances a Swissmedic / FOPH approval is also required. For these studies, both approvals must be obtained before starting the study.


If you plan to share Biological Material (BM) and/or any associated data with other researchers, include in your application dossier a:

  • Material Transfer Agreement (MTA)
  • Data Transfer Agreement (DTA)


These agreements define conditions and respective responsibilities regarding the sharing and use of BM and its associated data.

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

Swiss Law

ClinO – see in particular annex

  • Annex 3 Submission document list

ClinO-MD – see in particular annex

  • Annex 1 Submission document list

HRO – see in particular annex

  • Annex 2 Submission document list
  • BASEC – Business Administration System for Ethics Committees
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • DTA – Data Transfer Agreement
  • EC – Ethics Committee
  • eCRF – Electronic Case Report Form
  • FOPH – Federal Office of Public Health
  • GCP – Good Clinical Practice
  • GMO – Genetically Modified Organisms
  • HRO – Human Research Ordinance
  • ICH GCP – Council for Harmonisation Good Clinical Practice International
  • ICF – Informed Consent Form
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • MTA – Material Transfer Agreement
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Ethics Application ↦ Application Dossier

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 ↦ Application Dossier

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