What is it? Why is it important?

How to submit an amendment depends on type, thus whether it is a:

  • Safety amendment, or
  • Substantial (SA) or non-substantial amendment (N-SA)


With the exception of safety amendments, substantial amendments must be approved prior to implementation, and are submitted to the:

  • Ethics Committee (EC) for all studies under HRA
  • Swissmedic for:
  • FOPH for:
    • Transplantation studies of human organs, tissues and cells, or
    • Transplantation studies of embryonic of foetal tissues and cells


Non-substantial amendments are reported to:

  • Swissmedic for risk-category B and C studies as soon as possible
  • The EC in the annual safety report


In order to protect study participant, urgent protective safety measures are implemented prior to Swissmedic and EC approval. Still, they must be notified as soon as possible.

What do I need to do?

As a SP-INV and Site-INV:

  • In the event of a required safety amendment, immediately or as soon as possible:
    • Implement preventative safety measures
    • Notify the EC and if applicable Swissmedic


As a SP-INV:

  • Check the Swissmedic and EC homepage in order to determine whether a planned amendment is a SA or N-SA
  • Define reason(s) why you think an amendment is necessary
  • Adapt documents affected by the amendment and:
    • Ensure original text remains legible by using track-change mode
    • Create a “clean” version


Submit SAs to:

  • Electronically to EC via BASEC: Access “manage my applications” and upload amended documents (e.g. include both clean and track-changed document versions)
  • To Swissmedic using the:
    • Paper option (e.g. paper documents and CD sent by post), or
    • Paperless option (send only the “FO submission form” and CD by post)


When submitting a full paper option to Swissmedic ensure it is well organised:

  • Based on the scope of your amendment, create a binder with applicable sections using eDoc-file structure. File documents accordingly
  • For submission place:
    • Individual documents in a folder
    • Large quantities of documents in a binder using dividers
  • For the submission dossier, include both the folder/binder (paper copy) and CD (electronic copy)


In your cover letter, include information that could not be included in the FO submission form. Once the dossier has been received by Swissmedic, they will forward an acknowledgement of receipt.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Substantial amendment: YES or NO or "it depends"
  • BASEC: the EC submission portal

Swissmedic – see in particular

  • Human medicines / Clinical trials / Clinical trials on medicinal products / Submission of changes during the clinical trial and reporting
  • BW101_10_003e_AA, Guideline Amendments and reporting in clinical trials
  • FO-template: BW101_10_019e_FO confirmation electronic submission

Swiss Law

ClinO – see in particular articles and annexes

  • Art. 29 Changes IMP and other studies to EC
  • Art. 34 Changes IMP studies to Swissmedic
  • Art. 55-56 Changes transplant studies
  • Annex 3 EC submission
  • Annex 4 Swissmedic and FOPH submission

ClinO-MD – see in particular articles

  • Art. 15 Amendments to EC
  • Art. 20 Amendments to Swissmedic

HRO – see in particular article and annex

  • Art. 18 Changes
  • Annex 2 EC submission
  • 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
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • IMP – Investigational Medicinal Product
  • N-SA – Non Substantial Amendment
  • SA – Substantial Amendment
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Amendment ↦ 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): Conduct ↦ Ethics and Laws ↦ Amendment ↦ Submission

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