What is it? Why is it important?

Amendments are changes to an existing study protocol.

Amendments can either be:

  • Substantial (SA): with expected implications to the scope of the study (e.g. participant safety, responsibilities)
  • Non-substantial (N-SA): with no expected implications to the study scope ( more administrative / formal changes)

With the exception of safety amendments, SAs require approval before implementation. They must therefore be submitted and approved by EC and if applicable by Swissmedic.

Non-substantial amendments do not require initial approval before implementation, but are submitted to:

  • Swissmedic as soon as possible
  • The EC in the annual safety report

Safety amendments require special handling, as protective measures must be implemented prior to approval, in order to protect study participants. The EC and Swissmedic are 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
  • Define reason(s) why you think an amendment is necessary
  • Familiarise yourself with the required submission procedures

Examples of substantial amendments:

  • Changes needed to protect the safety and rights of study participants (safety amendment)
  • New scientific evidence becomes available requiring adaptations in study aim, safety concerns, statistical study plan
  • The required addition of additional study sites (multi-centre study)
  • Replacement of the Site-INV requiring a shift in site responsibilities

Where can I get help?

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

External References

Swissethics – see in particular

  • Substantial amendment: YES or NO or "it depends"

Swissmedic – see in particular

  • BW101_10_003e_AA Guideline Amendments and reporting in clinical trials

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

ClinO – see in particular article

  • Art. 29 Changes

ClinO-MD – see in particular articles

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

HRO – see in particular article

  • Art. 18 Changes
Abbreviations
  • 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
  • HRO – Human Research Ordinance
  • N-SA – Non-Substantial Amendment
  • SA – Substantial Amendment
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Amendment ↦ Type
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 ↦ Type

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