What is it? Why is it important?

The Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by ICH (International Council for Harmonisation).


Compliance with GCP standards provides public assurance that the rights, safety and well-being of study subjects are protected, and that study data are credible. In addition, it provides public assurance that standards are consistent with the principles that have their origin in the Declaration of Helsinki.


The ICH GCP E6 document address studies involving humans and gives guidance on how to design, conduct, record, and report clinical studies under ClinO.


In order to have the study approved by the Ethics Committee (EC), the SP-INV and applicable study staff, including any Site-INV(s) in a multicentre study, must submit proof of GCP training by providing an EC approved GCP certificate.


For studies with medical devices, the ISO 14155 is the required guideline. For studies with in vitro medical devices, the ISO 20916 is the required standard.


The World Medical Association (WMA) has developed the “Declaration of Helsinki” as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The document is regarded as a cornerstone on human research ethics.

What do I need to do?

As a SP-INV, Site-INV, and applicable study staff attend a swissethics recognised GCP course.


Course requirements are as follows:

  • The SP-INV must attend 2 GCP courses providing 2 separate certificates:
    • GCP Investigator-level course certificate
    • GCP Sponsor-investigator-level course certificate
  • The Site-INV or other study relevant staff must only attend an investigator-level GCP course


For medical device studies, it is highly recommended to attend as applicable an ISO 14155 or ISO 20916 training.


When submitting your study to the Ethics Committe for approval, include all relevant GCP certificate(s) . Ensure GCP courses are approved by swissethics, as foreign certificates might not be accepted.

Where can I get help?

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

External Links

Swissethics – in particular see

  • List of recognised GCP course providers


ICH GCP E6(R2) – see in particular guideline

  • Guidelines for Good Clinical Practice

Declaration of Helsinki – see in particular principles

  • 9 Protection of research subjects
  • 12 Qualification and training

ISO 14155:2020 Medical devices (access liable to costs) - see in particular

  • “Education” key word

Swiss Law

HRA – see in particular article

  • Art. 10 Scientific requirements

ClinO – see in particular articles

  • Art. 5 Good clinical practices
  • Art. 6 Professional qualifications
  • ClinO - Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA –Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • WMA – World Medical Association
Development ↦ Management ↦ Responsibilities ↦ Good Clinical Practice Training

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): Development ↦ Management ↦ Responsibilities ↦ Good Clinical Practice Training

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