Good Clinical Practice (GCP) Courses

Clinical Investigator I: Basic GCP and Clinical Research Training

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.

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

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

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.

• TUE, Sep 29, 2026

 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

Register

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database. 

Clinical Investigator II: Advanced GCP and Clinical Research Training

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.

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

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 

English

• TUE, May 5, 2026
• TUE, Nov 24, 2026

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

Register

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database. 

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.

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

GCP Refresher Training for Clinical Research

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.

• 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

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)..

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.

• TUE, Apr 21, 2026
• TUE, Oct 27, 2026

Fees based on affiliation.

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

Cancellation fee: 50 CHF

Register

Registration closes 31 March 2026.

Certificates are issued after verified course completion.

Course certificates require personal data recorded in an electronic database.