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 provides swissethics-recognized GCP curriculum tailored to the different roles in clinical research, such as Basic and Advanced GCP Training, as well as the GCP Refresher courses. 

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

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

Topics include

  • Introduction to Research Ethics
  • GCP
swissethics-recognized course
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.

Attendance appropriate for Principal Investigators (mandatory as a swissethics requirement), physicians, investigators, and study nurses/coordinators.
Structure

Two-day course splits in 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.
Language Course will be held in English
Course Dates
  • 25.02.2025
    • 1 full day
    • This course will be held on-site.  Location to be announced.
  • 29.04.2025 + 06.05.2025
    • 2 half days
    • This course will be held on site at sitem-insel, 3010 Bern
  • 30.09.2025
    • 1 full day
    • This course will be held on-site. Location to be announced.
Time 08:00-17:00
Fees 2025  Fees determined by affiliation.

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

Cancellation fee: 50 CHF
Registration

Register
Certification Certificate issued after verified course completion.

Attendance acknowledged with

  • 8 credits of the SGKPT, Schweizerische Gesellschaft für Klinische Pharmakologie und Toxikologie
  • 8 credits of the SGPM, Schweizerische Gesellschaft für Pharmazeutische Medizin

Course certificates requires personal data recorded in an electronic database. 
swissethics Recognition swissethics recognizes course fulfills the published requirements for the investigator level. Participants finishing this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.

Advanced GCP

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Clinical Investigators 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.
Attendance would be primarily appropriate for: Sponsor-Investigators (mandatory) and Principal Investigators initiating or directing clinical trials (as required by ethics committees and regulatory authorities). Others such as members of ethics committees, study nurses, biostatisticians and trial coordinators interested in clinical research are also welcome.
Language English
Course Dates
  • 04.03.2025
    • 1 full day
    • This course will be held on-site. Location to be announced.
  • 13.05.2025 + 20.05.2025
    • 2 half days
    • This course will be held on-site at sitem-insel, 3010 Bern
  • 07.10.2025
    • 1 full day
    • This course will be held on-site. Location to be announced.
Time 08:00-16:15
Fees 2025
 Fees determined by affiliation.

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

Cancellation fee: 50 CHF
Registration

Register
Certification Upon succesfully meeting requirements for course participation, certificates are issued. 

The attendance is acknowledged with
•    8 credits of the SGKPT, Schweizerische Gesellschaft für Klinische Pharmakologie und Toxikologie
•    6.5 credits of the SGPM, Schweizerische Gesellschaft für Pharmazeutische Medizin

Please note that for the issuance of a course certificate your personal data will be recorded in an electronic database. Your data will be treated confidentially and only used for internal purpose.
swissethics Recognition swissethics recognizes that the course fulfills the published requirements for the Sponsor-Investigator level. Participants finishing this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.
Prerequisites Before enrollment, course participants must provide a certificate of participation for Clinical Investigator I: Basic GCP & clinical research training.

GCP Refresher

DCR Education wants to set clear expectations for the content covered in the 3-hour December GCP Refresher course.

As a swissethics recognized course provider for GCP curriculum, DCR is obliged to use swissethics learning objectives and content for GCP Refresher courses. The GCP Refresher content is divided into 4 parts, including

  • part 1: basic principles
  • part 2: planning and preparation
  • part 3: execution
  • part 4: update on legal and ethical norms; advanced topics 

In parts 1–3, all relevant content has been revised based on the HRA ordinance update. Part 4 covers "some of the new developments in clinical research and some current burning themes." 

DCR is holding a 90-minute event dedicated to the HRA ordinance update at ASH on 12 February, which will be announced in the coming weeks. 

We hope this information helps set clear expectations for content covered in the 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 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.
Language English
Course Dates
  • 21.02.2025
    • 17:30-20:30,
    • This course will be held on site at Anna Seiler Haus, Insel.
  • 27.05.2025
    • Time yet to be defined.
    • This course will be held online via zoom.
  • 27.08.2025
    • Time yet to be defined.
    • This course will be held online via zoom.
Time 13:00-16:00
Fees 2025 Fees based on affiliation.

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

Cancellation fee: 50 CHF
Registration

Register

Registration closes 1 week before the course begins.
Certification GCP Refresher course certificate issued for verifiable attendance.

Register individually with your full name and attend the entire course and all 4 parts completely.

For issuing course certificates, we record personal data 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 provide a certificate of participation for either Clinical Investigator I: Basic GCP & clinical research training or Clinical Investigator II: Advanced GCP & clinical research training.