Good Clinical Practice (GCP) Courses

Good Clinical Practice (GCP) training is mandatory based on the specific role a researcher has in a clinical study, such as investigator, sponsor, or sponsor-investigator.

Regardless of the role in a clinical trial, it is recommended all study team members involved in a clinical trial or research project undergo at least the basic GCP Investigator training.

DCR offers a swissethics-recognized GCP curriculum tailored to different roles in clinical research, including Basic and Advanced GCP training as well as GCP refresher courses.

The courses are aligned with Swiss requirements and in accordance with the latest ICH GCP E6(R3) guidelines.

Detailed information on each course and the registration process is outlined below.

Validity of Training 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 implemented as outlined below, based on information the DCR obtained through communication with swissethics (27.04.26).

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 DCR courses are in line with R3 since the following dates:
    • Advanced GCP:  October 2025
    • Basic GCP:  September 2025
    • GCP Refresher: August 2025

Note: An Advanced GCP is only valid in combination with a valid Basic GCP.

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

  • Certificates issued before 1 January 2016
    • These certificates are no longer recognised by swissethics
    • You must complete a swissethics-accredited Basic GCP, possibly in combination with an Advanced GCP
    • Completion of an R3-GCP refresher course is not sufficient.
  • Certificates issued between 1 January 2016 and September 2025 (Basic GCP) or between 1 January 2016 and October 2025 (Advanced GCP)
    • The ethics committees will decide individually whether and in what form a retraining must be completed.
    • In most cases, however, a swissethics-accredited GCP refresher course of the ICH GCP E6(R3) version will be sufficient. The GCP-Refresher provided by the DCR corresponds to ICH GCP E6(R3) since August 2025
  • Certificates issued from September 2025 (Basic GCP) or from October 2025 (Advanced GCP)
    • The certificate corresponds to the currently valid guideline ICH GCP E6(R3) and is valid until further notice without retraining.

Note: An Advanced GCP is only valid in combination with a valid Basic GCP.

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 DCR and that we cannot make any statements or assessments about the validity of certificates from other course providers.

Basic GCP

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Clinical Investigator I: Basic GCP and Clinical Research Training
Goal

Basic GCP provides prospective clinical investigators with the essential knowledge of GCP and other regulatory and ethical requirements. Participants receive skills for contributing to clinical trials.
Content

swissethics-recognized course

Topics include

  • Introduction to research ethics
  • Patient information and consent
  • Critical protocol appraisal
  • Clinical data management systems and case report form
  • Investigators' responsibilities and monitoring
  • Basic statistical concepts and principles
  • Safety
Target Group

Basic GCP is designed to approach a broad audience from those who have little experience in clinical trials to those who wish to widen their knowledge of the conduct of such trials. Roles include:

  • Principal investigators (mandatory requirement of swissethics)
  • Physicians
  • Investigators
  • Study nurses/coordinators

 
Structure

The course is divided into 2 parts.

  • Part 1 consists of self-learning and home-based exercises. Participants have two weeks to complete the tasks.
  • Part 2 consists of a series of interactive lectures supplemented with workshops taught in one day.
  • The course concludes with an online exam.
Language English
Course Dates
  • TUE, Sep 29, 2026
Time TBC

Fees

 Fees determined by affiliation.

  • GHS PhD: 250 CHF (0.5 ECTS)
  • Inselspital, UniBe, DLF, & UPD: 760 CHF
  • Enrolled BFH Students: 330 CHF
  • Enrolled UniBern Students: 270 CHF
  • External: 950 CHF

 

Cancellation fee: 50 CHF
Registration

Register
Certification

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database. 

swissethics Recognition

 swissethics recognizes that this course fulfills the published requirements for the investigator level. Participants who successfully complete this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.

Advanced GCP

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Clinical Investigator II: Advanced GCP and Clinical Research Training
Goal

Advanced GCP provides prospective clinical investigators with the advanced knowledge of GCP and other regulatory and ethical requirements. In Clinical Investigator II, participants receive the knowledge and skills for developing study protocols, conducting clinical studies, and publishing study reports.
Content

One-day course consisting of a series of interactive lectures supplemented with workshops

Topics include

  • Role of a sponsor-investigator in a clinical study
  • Development of a scientific question into a research hypothesis
  • Essential methodological and statistical considerations
  • Feasibility assessments for a planned project
  • Quality of investigational medicinal products and medical devices
  • Submission and reporting requirements towards competent authorities
  • Transparency and reproducibility of study procedures and documentation
Target Group

Advanced GCP is relevant to those who are keen to gain more understanding of the design and conduct of clinical trials.Roles include:

  • Sponsor-Investigators (mandatory requirement of swissethics)
  • Principal Investigators initiating or directing clinical trials (as required by ethics committees and regulatory authorities)
  • Members of ethics committees
  • Study nurses
  • Biostatisticians
  • Trial coordinators interested in clinical research 
Language

English
Course Dates
  • TUE, May 5, 2026
  • TUE, Nov 24, 2026
Time

TBC
Fees

Fees determined by affiliation.

  • GHS PhD: 250 CHF
  • Inselspital, UniBe, DLF, & UPD: 600CHF
  • Enrolled UniBern Students: 225 CHF
  • External: 750 CHF

Cancellation fee: 50 CHF
Registration

Register
Certification

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database. 

swissethics Recognition

swissethics recognizes that this course fulfills the published requirements for the Sponsor-investigator level. Participants who successfully complete this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.
Prerequisites

Before enrollment, course participants must possess a Basic GCP certificate, such as the Clinical Investigator I: Basic GCP & clinical research training.

GCP Refresher

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GCP Refresher Training for Clinical Research
Goal

GCP refresher is aimed at providing a refresher training to clinical investigators with the essential knowledge of Good Clinical Practice (GCP) and of other regulatory and ethical requirements, and the skills for contributing to clinical trials.
Content
  • Research types
  • Laws & regulations in Switzerland
  • Roles & responsibilities within a study project
  • Project feasibility, costs, funding, budget
  • Quality management structures and key study document requirements
  • Task assignment
  • Submission & reporting requirements
  • Risk minimization
  • Handling and storage of study medication / medical devices
  • Study surveillance via monitoring, audits
  • Informed consent process
  • Protocol adherence
  • Safety reporting
  • Study end process and respective reporting obligations
  • Changes in the regulatory environment or other study relevant topics
Target Group

Designed for people with experience in clinical trials and who need GCP knowledge refreshed.

GCP Refresher does not replace Clinical Investigators Course I (Basic) and II (Advanced)..
Structure

Three-hour online course with 4 parts of 30 to 45 minute presentations, followed by Q & A. 

  • Part 1 consists of the basic principles and study project required documentation.
  • Part 2 addresses study preparation and conduct.
  • Part 3 focuses on study conduct and project closure.
  • Part 4 is kept flexible and addresses additional learning content, such as upcoming regulatory changes or key topics in clinical research.
Please note this is an online course via Zoom. Apart from the presentations on the course day, participants will also be provided with additional self-study material via our e-learning platform.  
Language English
Course Dates
  • TUE, Oct 27, 2026
Time TBC

Fees

Fees based on affiliation.

  • Inselspital, UniBe, DLF & UPD: 560 CHF
  • Enrolled UniBern Students: 210 CHF
  • External: 700 CHF

Cancellation fee: 50 CHF
Registration

Register

Registration closes 31 September 2026.
Certification

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database. 

swissethics Recognition

 swissethics has recognized that this training course fulfills the published requirements for GCP Refresher course program of Art. 10 HRA and Art.6 ClinO.
Prerequisites Before enrollment, course participants must possess either a Basic GCP certificate, such as the Clinical Investigator I: Basic GCP & clinical research training or an Advanced GCP certificate, such as the Clinical Investigator II: Advanced GCP & clinical research training.