What is it? Why is it important?

The International Council on Harmonisation Good Clinical Practice (ICH GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting studies involving human participants.


ICH GCP standards provide public assurance that:

  • The rights, safety, confidentiality and well-being of study participants are protected
  • Study data and reported results are accurate, credible, and of high quality


Important ICH GCP aims are to:

  • Provide unified standards in order to facilitate the mutual acceptance of studies by different RAs (e.g. Switzerland, EU, US, Japan, Australia, Canada, Nordic countries, WHO)
  • Ensure principles retain their origin and are consistent with the principles defined in the Declaration of Helsinki


ICH GCP guidelines do not apply to Medical Device studies. For MD studies ISO1455 standards apply.

What do I need to do?

When planning and conducting a study, ensure to comply with ICH GCP guidelines. As a SP-INV and Site-INV you are required to provide proof of GCP training (e.g. in some instances relevant study staff are also required to acquire a GCP certificate). 


In order to fulfil GCP requirements:

  • Attend a swissethics approved GCP course
  • Complete ICH GCP training courses based on whether you are a Site-INV or SP-INV
  • File individually issued GCP training certificates in the study TMF/ISF


Read the ICH GCP guidelies in conjunction with other study relevant ICH guidelines, such as:

  • E2A Clinical safety Data Management
  • E3 Structure and Content of Clinical Study Reports
  • E7 Studies in Support of Special Populations, Geriatrics
  • E8 General Considerations for Clinical Studies
  • E9 Statistical Principles for Clinical Trials
  • E11 Clinical Investigation of Medicinal Products in the Paediatric Population


  • GCP guidelines are not mandatory for HRO studies, but are highly recommended
  • CTUs offer swissethics approved face-to-face GCP training courses, including GCP-refresher courses
  • GCP online training courses are available. Prior to signing-up ensure these courses are approved by swissethics
  • Only trainings certificates obtained after 01.01.2014 are considered valid

Where can I get help?

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

External links

Swissethics – see in particular

  • Training / GCP courses / List of swissethics recognised research ethics and GCP course providers
  • Training / For investigators / Guidance for researchers regarding ethics and GCP training



  • ICH E2A Data management
  • ICH E3 Clinical study reports
  • ICH GCP E6(R2)
  • ICH E7 Special populations, geriatrics
  • ICH E8(R1) General considerations
  • ICH E9 Statistical principles
  • ICH E11 Paediatric population
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • EU – European Union
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ICH – International Council for Harmonisation
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF/ISF – Trial Master File / Investigator Site File
  • US – United States
  • WHO – World Health Organisation
Basic ↦ Ethics and Laws ↦ Guidelines ↦ Good Clinical Practice

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): Basic ↦ Ethics and Laws ↦ Guidelines ↦ Good Clinical Practice

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