- Teacher: Samantha Chan
- Teacher: Sylvain Losdat
- Teacher: Ueli Reber
- Teacher: Carl Starvaggi
- Teacher: Danielle Verschoor
- Teacher: Lidia Zabala
Clinical Investigators II: Advanced GCP
Module 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: Avanced GCP and Clinical Research Training.
For more information about GCP course, please visit DCR website or swissethics website.
Learning objectives
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