What is it? Why is it important?

An amendment are changes during study conduct of an EC, and if applicable RA, approved study. Amendments can either be:

  • Substantial, or
  • Non-substantial, or
  • Safety amendments (always considered a substantial amendment)

Substantial amendments require prior EC/RA approval. Exception are safety amendments where protective measures are immediately implemented (e.g. or as soon as possible) in order to protect study participants.

Apart from the protocol, an amendment might result in changes to other EC approved study documents such as the PIS and ICF.

What do I need to do?

Based on problems or situations encountered during study conduct:

  • Decide whether an amendment is necessary
  • Apart from the protocol, identify documents that must be adapted as they become affected by the amendment (e.g. PIS/ ICF, CRF, etc.)
  • Prepare the amended documents and submit the request for an amendment to the EC and if applicable RA (e.g. Swissmedic)

Prepare the amended documents as follows:

  • Create the amended documents in a clean and track-change version
  • Adapt the document identification accordingly (e.g. date, version)
  • Summarize changes in the cover letter
  • Submit the amendment to EC, and if applicable RA, for approval

The amendment can only be implemented in the study after EC/RA approval has been received

For more information refer to Protocol in this Study Guide.

More

Except for safety amendments, carefully evaluate whether a substantial amendment is necessary. Note that preparing and submitting an amendment dossier to EC/RA, as well as implementing the amendment will require additional resources (e.g. staff, finances). An amendment might both increase the cost and the duration of the study.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Notification of significant and other changes to the EC

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.44 Protocol definition
  • 1.45 Protocol Amendment definition
  • 4.5 Compliance with Protocol
  • 6 Clinical Trial Protocol and Protocol Amendment(s)

ISO 14155:2020 Medical devices – see in particular sections (access liable to cost)

  • 6.4 Clinical investigational plan (CIP)
  • 7.5.1 Amendments
  • 10.5 Informed consent procedure
  • 10.6 Compliance with CIP
  • Annex A Clinical investigational plan

Swiss Law

ClinO – see in particular articles

  • Art. 29, 34, 55 Changes

HRO – see in particular article

  • Art. 18 Changes
Abbreviations
  • CIP – Clinical investigational plan
  • ClinO – Clinical Trials Ordinance
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • PIS – Participant Information Sheet
  • RA – Regulatory Authorities
  • SD – Source Data
Conduct ↦ Documents ↦ Required Documents ↦ Amendment
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 ↦ Documents ↦ Required Documents ↦ Amendment

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