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Good Clinical Practice (GCP)

Depending on the responsibility (Investigator, Sponsor-Investigator), Good Clinical Practice (GCP) courses are mandatory. The courses are recommended for all study team members contributing to a clinical trial or research project under the Human Research Ordiance (HRO).

GCP-Basiskurs (DE)

GCP-Aufbaukurs (DE)

GCP-Refresher (EN)

Direct link to registration

For questions & consulting:

Validity of course certificates

As of 21 December 2025, swissethics and Swissmedic have revised the validity of GCP course certificates for all principal investigators. The reason for this is the fundamentally revised version R3 of the ICH GCP E6 guideline (ICH GCP E6(R3)), which has come into force in August 2025.

In practice, the new regulation is handled as shown below (according to information provided by Nienke Jones, Head of Scientific Secretariat, Ethics Committee Northwestern and Central Switzerland (EKNZ) on 11.02.2026).

Please note, that ethics committees only check the GCP training of investigators and sponsor-investigators, but strongly recommend that all other persons involved in a study are also trained. In addition, the lack of qualifications of all persons involved in a study can lead to inspection findings.

The following applies to studies that have already been approved:

  • You must complete or have registered for a swissethics-accredited GCP refresher course of the ICH GCP E6(R3) version no later than 1 year after Annex II to ICH GCP E6(R3) comes into force . Annex II is currently expected to enter into force in summer 2026 at the earliest.
  • Until you have completed this course, you must undertake and document a self-study of these training materials on the contents of the ICH GCP E6(R3) guideline.
  • There is no obligation to inform the ethics committees about the self-study or the completion of an R3-GCP refresher.
  • Retraining (see above) is not required if you have already completed a course whose content corresponds to ICH GCP E6 (R3). The DKF courses are in line with R3 since the following dates:
    • GCP-Refresher since 15 July 2025
    • GCP-Basiskurs since 24 June 2025
    • GCP-Aufbaukurs since 11 September 2025
      Note: A GCP-Aufbaukurs (equivalent to a Sponsor-Investigator course) is only valid in combination with a valid GCP-Basiskurs (equivalent to an Investigator course).

The following applies to new studies to be submitted for approval:

  • Certificates issued before 1 January 2016
  • Certificates issued between 1 January 2016 and 23 June 2025 (GCP-Baiskurs) or between 1 January 2016 and 10 September 2025 (GCP-Aufbaukurs)
  • Certificates issued from 24 June 2025 (GCP-Basiskurs) or from 11 September 2025 (GCP-Aufbaukurs)
    • The certificate corresponds to the currently valid guideline ICH GCP E6(R3) and is valid until further notice without retraining.
      Note: A GCP-Aufbaukurs (equivalent to a Sponsor-Investigator course) is only valid in combination with a valid GCP-Basiskurs (equivalent to an Investigator course).

In all cases, the decision regarding the necessary training is the responsibility of the relevant ethics committee. Please note, that all the information above relates to certificates issued by the DKF Basel and that we cannot make any statements or assessments about the validity of certificates from other course providers.

About GCP

In order to ensure the safety of study participants and high quality in clinical studies, professional knowledge and continuous compliance with national legislation and international standards, such as Good Clinical Practice (GCP), are required.

What is ICH-GCP?

The organisation "ICH (International Council for Harmonisation)" first published an internationally recognised Good Clinical Practice (GCP) guideline in 1996. This guideline defines principles that are now regarded as the globally accepted ethical, scientific and operational standard for human research. ICH-GCP has not only become one of the main references for the Swiss Human Research Act (HFG), but also forms the content basis for the nowadays obligatory training courses for investigators in clinical studies.

 

For whom are GCP courses mandatory or recommended?

Swissethics (Swiss Ethics Committees for Human Research) defines the mandatory requirements regarding research ethics and GCP for researchers in clinical studies in Switzerland. These differ according to the GCP training level "investigator level" and "sponsor-investigator level", which is reflected in the GCP courses:

GCP basic course with swissethics recognised "investigator level" certificate

  • Mandatory for investigators (according to Art. 2d KlinV) in clinical research (according to Art. 3l HFG)
  • Recommended for all study team members in clinical studies (e.g. investigators, study nurses, study managers, study coordinators, monitors)

GCP advanced course with swissethics recognized certificate "sponsor-investigator level"

  • Mandatory for investigators with sponsor responsibility (sponsor-investigator according to Art. 2 c and d KlinV)
  • Recommended for all employees involved in clinical trials (e.g. investigators, study nurses, study managers, study coordinators, monitors)

GCP Refresher course with swissethics recognized certificate

  • Recommended for investigators, investigators with sponsor responsibility and clinical trial staff who wish to refresh their GCP knowledge or are required to do so by industry or ethics committees

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