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Course Overview

Summary

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.

Target audience

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. Others such as members of ethics committees, study nurses, biostatisticians and trial coordinators interested in clinical research are also welcome.

Relevance to Clinical Practice/Research

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.

After taking the Clinical Investigator I: Basic GCP, swissethics recommends Sponsor-Investigator in clinical research to follow the course Clinical Investigator II: Advanced GCP and Clinical Research Training.

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

Clinical Investigators II: Advanced GCP

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 II courses.

At the end of the course, participants should be able to

Describe the combined role of a sponsor-investigator in a clinical study
Develop a scientific question into a research hypothesis
Explain essential methodological and statistical considerations
Conduct feasibility assessments for a planned project
Ensure quality of investigational medicinal products and medical devices
Describe submission and reporting requirements towards competent authorities
Ensure transparency and reproducibility of study procedures and documentation

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.

Costs, Budgets and Contracts in Clinical Trials

Learner Task - 1

Investigational Medicinal Product (IMP)

Learner Task - 1

Regulatory Affairs and Submission

Learner Task - 1

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 Tuesday 22 December 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 Tuesday 22 December 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 May 2027. 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

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