Good Clinical Practice I: Investigator Level
Course Overview
Course Introduction
This course is designed to provide prospective clinical investigators with the basic knowledge of Good Clinical Practice (GCP) and other regulatory and ethical requirements, and the skills to contribute to clinical trials.
Topics covered 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 audience
The course is designed to reach a wide audience, from those with little experience of clinical trials to those wishing to broaden their knowledge of the conduct of such trials.
Attendance is primarily appropriate for:
Principal Investigators (mandatory), physicians, investigators, study nurses/coordinators who recruit patients into clinical trials, inform or treat patients, conduct follow-up (as required by ethics committees and regulatory authorities).
Others such as ethics committee members, biostatisticians interested in clinical research are also welcome.
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.
For more information about GCP course, please visit DCR website or swissethics website.
Legal requirements
Swissethics has recognised that this course fulfils the published requirements for Investigator Level courses. Participants who complete this training program fulfil the requirements of Art. 10 HRA and Art.6 ClinO.
Additional information
If you have further questions or require additional information please send an email to: education.dcr@unibe.ch.
Content
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 I courses.
At the end of the course, participants should be able to
- Explain the importance of conducting research involving human participants for the advancement of biomedical sciences and in the interest of public health
- Explain the importance of protecting human participants in the design, conduct and followup of research projects involving human beings
- Describe the fundamental principles of human research participant protection including autonomy, beneficence, non-maleficence and justice
- Identify and describe the basic documents of reference in research ethics (from Declaration of Helsinki to ICH-GCP) including the applicable law and regulation in Switzerland
- Describe how conflicts of interest may impact the design, conduct and follow up of a research project and what are the main measures to limit them
- Explain the negative impact of fraud and science misconduct and name measures to act against them
- Identify the basic rules of research ethics applicable in given situations and apply them to solve simple cases, in particular:
- Assuring a proper balance of the risks and the benefits in a given research project (defining and assessing the risks)
- Obtaining a valid informed consent, including in situations where potential participants are legally incompetent (minors/incapacitated adults) or from a vulnerable group
- Respecting the privacy of the participants as well as the data protection requirements in collecting, processing and storing data/human biological materials
- Obtaining ethical clearance from the competent Research Ethics Committee (REC)
- Describe the responsibilities of investigators in the protection of human participants and how they have the capacity to face them
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.
Statistical Concepts I
- Learner Task - Kidney stones - Identify RCT study designs
- Learner Task - Confidence intervals and p-values
- Learner Task - Statistical variables
Investigator's responsibilities & Monitoring
- Learner Task - Essential documents
- Learner Task - Sponsor-Investigator Responsibilities – PMCF Monitoring
- Learner Task - Site Initiation Visit – Training Flexibility for Large Study Teams
- Learner Task - Types of Monitoring Visits
- Learner Task - Monitoring activities
- Learner Task - Investigator Responsibility
Safety management in clinical trials
- Learner Task - Events Types
- Learner Task - Heart Valve Prosthesis Adverse Event
- Learner Task - Athlete's Foot in Aquatic Physiotherapy Trial
- Learner Task - Leg Fracture in Diclofenac Cream Trial
- Learner Task - Elevated Liver Enzymes in Hepatitis C Trial
- Learner Task - Fall and Hip Fracture in Robotic Device Trial
Critical Protocol Appraisal
Investigational Medicinal Product (IMP)
Ethics & History
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
