GCP Refresher
Module Overview
Summary
GCP refresher is aimed at providing a refresher training to clinical investigators with the essential knowledge of Good Clinical Practice (GCP) and of other regulatory and ethical requirements, and the skills for contributing to clinical trials.
Target audience
Designed for people with experience in clinical trials and who need GCP knowledge refreshed. GCP Refresher does not replace Clinical Investigators Course I (Basic) and II (Advanced).
Relevance to Clinical Practice/Research
Clinical research often involves complex interventions and real patients, making clear standards essential to prevent harm, unreliable findings, and loss of public trust. GCP provides a structured framework to
- protect participants
- ensure accurate and traceable data
- meet regulatory, ethical requirements and scientific journals.
Beyond compliance, GCP helps prevents clinical trials from failing.
| Common avoidable errors | Potential consequences |
|---|---|
|
incomplete documentation, |
ethics resubmissions |
|
protocol deviations, |
trial delays |
|
poor consent processes |
rejected publications |
|
data inconsistencies |
invalid study results |
Evidence from clinical trial audits and peer-reviewed studies consistently shows that many of these problems are not due to complex science, but to gaps in applying GCP principles in practice.
Our GCP courses are designed to support you not only in understanding these principles, but in applying them confidently in your day-to-day research work.
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 Refresher courses.
At the end of the course, participants should be able to
- Describe the different types of human research including the applicable law and regulations in Switzerland
- Determine the study feasibility in terms of patient recruitment, resources and logistics needed, time and budget and regulatory obligations
- List the roles and responsibilities of all those involved in the study and their working relations
- Know the essential study documents and their "raison d'être"
- Know how to conduct a clinical trial
- Know the roles and responsibilities of the investigator and site staff, the tools and documents needed
- Know how to track and keep records during the style="text-align: justify;" course of the study
- Know the informed consent process and the managementof subjects' safety and safety reporting
- Know how to handle, store and document the study medication and medical devices
- Be up to date with some of the new developments in clinical research and some current burning themes (new regulations and standards, new modes of operation and tools,...)