Summary
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.
Target Audience
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.
Attendance appropriate for Principal Investigators (mandatory as a swissethics requirement), physicians, investigators, and study nurses/coordinators.
Relevance to Clinical Practice
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.
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.
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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
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