What is it? Why is it important?

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

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

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

  • EC for all studies under HRA
  • Swissmedic for:
    • ClinO studies with risk categories B and C
    • ClinO-MD studies with risk category C
  • 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 participant safety, requires that safety amendments be 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:

  • Immediately, or as soon as possible, implement, in the event of a safety amendment, required protective measures

As a SP-INV:

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

For SAs submit:

  • Electronically to EC via BASEC:
    • Access “manage my application”
    • 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)

More

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 file:
    • 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

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

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
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
  • EC – Ethics Committee
  • FEDLEX - Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • IMP
  • N-SA – Non Substantial Amendment
  • SA – Substantial Amendment
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Amendment ↦ Submission
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): Conduct ↦ Ethics and Laws ↦ Amendment ↦ Submission

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