Course Introduction
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.
Target audience
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).
Relevance
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.
Clinical research often involves complex interventions and real patients, making clear standards essential to prevent harm, unreliable findings, and loss of public trust. GCP provides a structured framework to:
- protect participants
- ensure accurate and traceable data
- meet regulatory, ethical requirements and scientific journal standards
Beyond compliance, GCP helps prevent clinical trials from failing.
Evidence from clinical trial audits and peer-reviewed studies consistently shows that many of these problems are not due to complex science, but to gaps in applying GCP principles in practice.
Our GCP courses are designed to support you not only in understanding these principles, but in applying them confidently in your day-to-day research work.
After taking the Clinical Investigator I: Basic GCP and Clinical research Training, swissethics recommends to maintain knowledge through different activities including attending GCP Refresher courses. If swissethics judge that the knowledge has not been maintained, they can request the researchers to participate again to a recognized GCP course.
For more information about GCP course, please visit DCR website or swissethics website.
Additional information
If you have further questions or require additional information please send an email to: education.dcr@unibe.ch.
Content
Disclaimer
These materials were developed by subject-matter experts, refined with the support of AI tools, and reviewed by a medical education specialist before release. Feedback on content or tasks is welcome.
Learning Outcomes
Note: As a swissethics recognized course provider for GCP curriculum DCR is obliged to use swissethics learning objectives and content for GCP Refresher courses.
At the end of the course, participants should be able to
- Describe the different types of human research including the applicable law and regulations in Switzerland
- Determine the study feasibility in terms of patient recruitment, resources and logistics needed, time and budget and regulatory obligations
- List the roles and responsibilities of all those involved in the study and their working relations
- Know the essential study documents and their "raison d'être"
- Know how to conduct a clinical trial
- Know the roles and responsibilities of the investigator and site staff, the tools and documents needed
- Know how to track and keep records during the course of the study
- Know the informed consent process and the management of subjects' safety and safety reporting
- Know how to handle, store and document the study medication and medical devices
- Be up to date with some of the new developments in clinical research and some current burning themes (new regulations and standards, new modes of operation and tools,...)
Assessment
Below are links to the individual assessment activities for each module. These assessments are not mandatory and do not count toward your course completion or certificate — they are provided purely as a self-evaluation tool.
Study Conduct and Closure
Costs and budgets of clinical trials
Final Assessment
This is a compulsory final assessment to receive your course certificate. The assessment can be taken from home here on Moodle. It will be available after the course and will be open until Saturday 31 October 2026. You can take the exam at any time during this period.
The exam consists of multiple choice questions. The exam language is English.
Link to Final Assessment
Important information:
- You have 90 minutes to complete the exam
- You can take the exam up to 5 times.
- If you have any problems with the exam, please contact education.dcr@unibe.ch
Course Evaluation
We are always trying to improve our courses. Your feedback, whether positive or negative, is therefore very welcome.
Please feel free to make any suggestions for improvement regarding the organisation and delivery of the course.
Please also remember that the evaluation is mandatory in order to receive the course certificate and must be completed by Saturday 31 October 2026.
Thank you very much for your feedback!
Link to Mandatory Course Evaluation
Certificate
You will be able to download your certificate below once the following criteria have been met:
- Your attendance has been confirmed (this may take up to 48 hours after the course)
- You have successfully passed the exam.
- You have completed all online modules.
- You have completed the course evaluation.
Important! Please download your certificate by Monday 31 December 2026. After this date the certificate will no longer be available for download.
If you have any questions or require further information please email us at: education.dcr@unibe.ch.
Link to Certificate
