What is it? Why is it important?

Amendments are changes to the study protocol during study conduct. Amendments cane either be substantial or non-substantial. Changes impacting the collection of study data are generally substantial amendments (e.g. the inclusion of additional study site(s) or data).


Examples of amendments that affect data collection

  • New scientific evidence becomes available that require an adaptation regarding study aim, safety concerns, data collection and statistical study plan
  • The collected data is shown to be inadequate to answer the study question. The collection of additional data (e.g. variables) becomes necessary (e.g. additional blood samples, medical tests, participant feedback)
  • Total number of study participants needs to be increased. In order to gain access and recruit adequate participants the inclusion of additional study-site(s) becomes necessary


Substantial amendments require:

  • An initial protocol revision followed by an approval by the EC if applicable RA (e.g. Swissmedic)
  • Applicable adaptations to the study database (eCRF)
  • Validation, approval and release of the newly adapted database

What do I need to do?

As a SP-INV and in collaboration with the study Data Manager (DMan) and Statistician, evaluate the impact of an amendment on:


Implement an amendment:

  • In collaboration with the DMan
  • Only once EC if applicable RA (e.g. Swissmedic) approval has been received
  • Establish and save the database as a new updated version
  • Validate the amended database and ensure it works as intended
  • Train staff on applicable changes
  • Upon successful validation and training release the amended database for data entry

Where can I get help?

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

External Links

Swissethics – search in particular

  • Definition of substantial and non-substantial amendments


ICH GCP E6(R2) – see in particular guidelines

  • 5.5. Trial Management, data handling, and record-keeping
  • CTU – Clinical Trials Unit
  • DMan – Data Manager
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • pCRF – paper Case Report Form
  • RA – Regulatory Authorities
  • SP-INV – Sponsor Investigator
Conduct ↦ Data Handling ↦ Data Handling ↦ Amendment

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Data Handling ↦ Data Handling ↦ Amendment

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