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 and credible

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?

Comply with ICH GCP guidelines when planning studies that require initial EC/RA approval.

GCP should be read in conjunction with 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

Both the SP-INV and the Site-INVs 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

More

  • 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

References

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

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