GCP Refresher

Informations

This course is intended for research staff who already hold a GCP certificate but wish to update their knowledge: Investigators, Investigator-Sponsors, Co-Investigators, and non-medical research personnel.

IT DOES NOT REPLACE A FIRST- OR SECOND-LEVEL GCP CERTIFICATE.

Date:  April 29th 2026
Place: TBD – Campus EST, Settore A, USI Lugano

Modality:

GCP training may include classroom teaching, online modules, self-study, or homework assignments. Although online training is recognized, swissethics strongly recommends completing the course (or part of it) with face-to-face (F2F) training. An online knowledge-assessment test must be completed within two weeks after the end of the GCP course.

Objectives:

• By the end of the course, participants are able to describe the different types of human research and the applicable Swiss laws and regulations.
• By the end of the course, participants are able to assess the feasibility of a study in terms of patient recruitment, required resources and logistics, time, budget, and regulatory obligations. They are able to list the roles and responsibilities of all individuals involved in the research study and understand their working relationships. They are familiar with the essential study documents and their purpose.
• By the end of the course, participants know how to conduct a clinical trial. They understand the roles and responsibilities of the investigator and study staff, the tools and documents required, how to track and retain study data, and how to manage the study throughout its duration. They are familiar with the informed consent process, subject safety management and adverse event reporting, as well as the handling, storage, and documentation of investigational medicinal products and medical devices.
• Participants are updated on new developments in clinical research and current topics (new regulations and guidelines, new operational approaches and tools, etc.).