What is it? Why is it important?

Prior to implementation, an amendment must be approved by the Ethics Committee (EC) and if applicable Swissmedic. Amendments that do not require prior approval are:

  • Urgent safety measures to protect study participants against any immediate hazard
  • Non-substantial amendments


The approval process includes:

  • Potential clarification between  the SP-INV and EC/Swissmedic
  • The submission of amended documents, including the rational for the amendment
  • EC/Swissmedic processing timelines including potential question/answer sessions
  • The issue of an official EC/Swissmedic decision letters


The decision letter either states that the amendment is:

  • Approved and can be implemented
  • Approved based on given preconditions
  • Rejected and cannot be implemented


Substantial amendment response timelines:

  • ClinO studies: 30 days for EC, Swissmedic (e.g. risk-category B and C), and FOPH
  • ClinO-MD studies:
    • 30 days for EC
    • 38 days for Swissmedic (e.g. risk-category C), can extend with 7 days
  • HRO projects: 30 days for EC

What do I need to do?

As a SP-INV consider EC/Swissmedic processing timelines, and:

  • Plan your amendment accordingly
  • Prepare for potential question/answer sessions


Once the amendment is EC/Swissmedic approved:

  • If applicable, inform participating study sites (e.g. Site-INV(s))
  • Train study staff on the amendment and document training in a training-log
  • If applicable, ask study participants to re-consent to changes by signing the amended Informed Consent Form
  • Implement and follow a robust document filing and tracking system (e.g. document management), such as:
    • To ensure outdated documents are clearly identified as such (e.g. date of archiving), and replaced by amended ones
    • To enable document traceability, archived electronic documents are in read-only format
  • Review amended procedures in order to ensure they are correctly implemented


For Swissmedic approved studies (e.g. risk-category B and C), an amendment that results in the change of a study SP-INV, requires an approval at least 30 days prior any planned take-over.

Where can I get help?

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

Swiss Law

ClinO – see in particular articles

  • Art. 29 Changes IMP and other studies to EC
  • Art. 34 Changes IMP studies to Swissmedic
  • Art. 55-56 Changes transplant studies

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
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FOPH – Federal Office of Public Health
  • HRO - Human Research Ordinance
  • IMP – Investigational Medicinal Product
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Amendment ↦ Approval

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 ↦ Approval

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