What is it? Why is it important?

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

The dossier contains among others:

  • A cover letter
  • The study protocol
  • The participant information and informed consent form, including any materials distributed to participants (e.g. advertisements, questionnaires)
  • A list of variables to be collected or the study eCRF
  • The CV of the SP-INV
  • Relevant contract(s)
  • Insurance certificate (HRO 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)
  • DTA / MTA for sharing biological material and/or health-related personal data
  • Proof of participant death for studies with deceased persons

More

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?

Familiarise yourself with how EC processes an application dossier. The EC will:

  • Only view your application dossier once all the required documents have been uploaded on BASEC
  • 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:

  • 30 days for Investigational Medicinal Product (IMP) monocentric studies
  • 45 days for IMP multicentre studies, or studies with ionising radiation
  • 40 days for IMD studies
  • 60 days for studies with gene therapy, GMO, pathogenic organisms, and studies involving ionising radiation

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

More

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 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 biological material and its associated data.

Where can I get help?

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

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
Abbreviations
  • 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
  • FEDLEX – Publication Platform for Federal Laws
  • 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
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): Development ↦ Ethics and Laws ↦ Ethics Application ↦ Application Dossier

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