What is it? Why is it important?

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

The Efficacy Guideline E6 document gives guidance on how to design, conduct, record and report clinical studies involving human subjects.

GCP compliance provides assurance that the rights, safety, and well-being of study participants are protected.

In order to receive EC approval for the study, the SP-INV and if applicable Site-INV and other study staff must submit their GCP training certificates.

For studies with medical devices, the ISO 14155 is the required guideline.

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Standards are consistent with principles that have their origin in the Declaration of Helsinki.

What do I need to do?

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
    • GCP Sponsor-investigator level
  • The Site-INV or other study relevant staff must only attend the GCP course for investigator level.

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

Include all relevant GCP certificate(s) when submitting your study to the applicable EC. Ensure GCP courses are approved by swissethics, as foreign certificates might not be accepted.

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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 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.

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

References

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 “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
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • 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
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): Development ↦ Management ↦ Responsibilities ↦ Good Clinical Practice Training

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