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-approved GCP courses 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 This course is aimed at providing prospective 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

The topics covered will include:

  •  Ethical and legal principles
  •  Swiss regulations for research involving humans
  • (HRA, ClinO, HRO and OrgO)
  •  GCP guidelines
  •  Basics of clinical research and study designs
  •  Basics of data management in clinical research
  •  Patient information and consent
  •  Study conduct & quality assurance
  •  Safety
Target Group
 The course 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 would be primarily appropriate for: Principal Investigators (mandatory as a Swissethics requirement), physicians, investigators, study nurses/coordinators rec
Structure

This is a two-day course split in two parts.

  • The first part consists of self-learning and home-based exercises. Participants have two weeks to complete the tasks.
  • The second part consists of a series of interactive lectures supplemented with workshops tought in one day.
Language Course will be held in English
Course Dates
  • 25.02.2025
    • 1 full day on site at Mittelstrasse 43, 3012 Bern
  • 29.04.2025 + 06.05.2025
    • 2 half days on site at sitem-insel, 3010 Bern
  • 30.09.2025
    • 1 full day on site at Mittelstrasse 43, 3012 Bern
Fees 2024 CHF 400 for internal participants (staff and students of Bern University Hospital and University of Bern)

CHF 700 for external participants
Registration

Registration for 2025 courses opens on November 11.
Certification Certificate will be issued at the end of the course.

The attendance is acknowledged with

  • 8 credits of the SGKPT, Schweizerische Gesellschaft für Klinische Pharmakologie und Toxikologie
  • 8 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 purposes
Swissethics Recognition Swissethics has recognized that this training course fulfills the published requirements for Sponsor-Investigator Level courses. Participants finishing this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.
Description GCP I (PDF, 200KB)

Advanced GCP

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Clinical Investigators II: Advanced GCP and clinical research training
Goal This course is aimed at providing investigators with advanced knowledge of Good Clinical Practice and of other regulatory and ethical requirements, and the knowledge and skills for developing study protocols, conducting clinical studies and publishing study reports.
Content

This one-day course will consist of a series of interactive lectures supplemented with workshops

The topics covered will include:

  •  Ethical and legal principles
  •  Swiss regulations for research involving humans
  • (HRA, ClinO, HRO and OrgO)
  •  GCP guidelines
  •  Basics of clinical research and study designs
  •  Basics of data management in clinical research
  •  Patient information and consent
  •  Study conduct & quality assurance
  •  Safety
Target Group
 This course 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 Course will be held in English
Course Dates
  • 11.11.2024
    • 1 full day from 08:30 - 17:30.
    • This course will be held on-site at Mittelstrasse 43, 3012 Bern
  • 04.03.2025
    • 1 full day
    • This course will be held on-site at Mittelstrasse 43, 3012 Bern
  • 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 at Mittelstrasse 43, 3012 Bern
Fees 2024
 CHF 300 internal participants (staff and students of Bern University Hospital and University of Bern)
CHF 500 external participants
Registration

Please register for the 2024 course here. Registration is possible until one week before course start.

Registration for 2025 courses opens on November 11.
Certification Certificate will be issued at the end of the course.

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 has recognized that this training course fulfills the published requirements for Sponsor-Investigator Level courses. Participants finishing this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.
Description GCP II (PDF, 131KB)

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 This course 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

Overall the following areas will be covered:

  • 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
 The course is designed to approach those who have already gained experience in clinical trials and wish to refresh their knowledge of the conduct of such trials.

Open for study nurses, Principal Investigators.


Please note: this GCP course does not replace the Clinical Investigators Course I and II (Basic, Advanced), as it is a refresher of those course contents only.
Structure

This half-day compact course consists of four parts of 30 to 45 minute presentations, followed by a question
and answer session. The course can only be attended as a whole.

  • Part 1 consists of the basic principles and study project required documentation.
  • Part 2 addresses study preparation and conduct.
  • Part 3 continues on study conduct and project closure.
  • Part 4 is kept flexible and will address additional learning contents such as upcoming regulatory changes or key topics in clinical research.
Language The teaching language is English. Discussions are held in English or German.
Course Dates
  • 03.12.2024
    • 13:00 -16:00,
    • This course will be held online via zoom.
  • 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.
Fees 2024
 CHF 120
Registration

Please register for the 2024 courses here. Registration is possible until one week before course start.

Registration for 2025 courses will open on November 11, 2024.
Certification Certificate will be issued at the end of the course.

In order to obtain GCP Refresher course certification, you are required to register individually with your full name and attend the entire course, i.e. attend all four parts in full length.

 

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 purposes
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.
Description GCP Refresher (PDF, 165KB)