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).

 

Compliance with GCP standards provides public assurance that the rights, safety and well-being of study participants are protected, and that study data is credible. It provides public assurance that standards are consistent with principles defined 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.

 

To obtain approval by the Ethics Committee (EC), the SP-INV, Site-INV(s), and relevant study staff must submit proof of EC-approved GCP training (i.e. by providing an EC approved GCP certificate).

 

ISO 14155 standard provides GCP for clinical investigations of medical devices.

 

ISO 20916 standard provides GCP for clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices..

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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 ensure to attend a swissethics recognised GCP course (note: foreign certificates might not be accepted). File the GCP certificate in a safe place for later reference (e.g. will be requested during regulatory inspections)

 

Course requirements are as follows:

  • The SP-INV must attend 2 GCP courses providing 2 separate certificates:
    • An investigator-level (Site-INV) GCP certificate
    • A sponsor-investigator-level (SP-INV) GCP certificate
  • The Site-INV or other study staff must only attend an investigator-level GCP course

 

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

 

When submitting your study to the Ethics Committe enure to include all relevant GCP certificate(s) . 

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 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
Abbreviations
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
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.