Clinical Investigators I: Basic GCP
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.
Certificate
Certificate will be issued at the end of the course.
Additional information
If you have further questions or require additional information please send an email to: education.dcr@unibe.ch.
Content
General information
Course name
Clinical Investigators I: Basic GCP
Clinical trial safety - Adverse events
Course name
Clinical Investigators I: Basic GCP
Critical protocol appraisal
Course name
Clinical Investigators I: Basic GCP
Investigator's responsibilities & Monitoring
Course name
Clinical Investigators I: Basic GCP
Investigational Medicinal Product (IMP)
Course name
Clinical Investigators I: Basic GCP
Methodological and Statistical Essentials
Course name
Clinical Investigators I: Basic GCP
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.
Clinical Trial Safety – Adverse events
Critical Protocol Appraisal
Investigator's responsibilities & Monitoring
No assessment currently available.
Investigational Medicinal Product (IMP)
Methodological and Statistical Essentials
No assessment currently available.