VVZ API is not affiliated with ETH Zurich. Data might be outdated or incorrect. Please view the official ETHZ Vorlesungsverzeichnis for binding information.
GCP Basic Course (Modules 1 and 2)
Last Updated: 2026-02-05 16:14:37
Abstract
The basic course in "Good Clinical Practice" (GCP) contains of two full-time training days (Module 1 and Module 2) and addresses elementary aspects for the appropriate conduct of clinical trials and non-clinical research projects involving human beings. Successful participation will be confirmed by a certificate that is recognized by the Swiss authorities.
Objective
Students will get familiar with: - Key Ethics documents - (Inter)national Guidelines and Laws (e.g. ICH-GCP, DIN EN ISO 14155, TPA, HRA) - Sequence of research projects and project-involved parties - Planning of research projects (statistics, resources, study design, set-up of the study protocol) - Approval of research projects by Authorities (SwissEthics, Swissmedic, FOPH) - Roles and responsibilities of project-involved parties Students will learn how to: - Classify research projects according the risk-based approach of the HRA - Write a study protocol - Inform participating patients/study subjects - Obtain consent by participating patients/study subjects - Classify, document and report Adverse Events - Handle projects with biological material from humans and/or health- related personal data
Content
Module 1: Research and Research Ethics, Guidelines, (inter)national Legislation, Development of therapeutic products, Methodology (Study Design), Study documents (Study protocol, Investigator's Brochure, Patient Information Leaflet, Informed Consent Form) Module 2: Roles and Responsibilities, Approval procedures, Notification and Reporting, Study documentation, Research with biological material and health-related data, data protection, data retention
General Information
- Language
- English
- Levels
- DR , MSC
- Frequency
- Semesterly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
GCP Basic Course (Modules 1 and 2)
Courses for German speaking students:
Several dates are offered throughout the year; new dates are published quaterly.
Please select courses (GCP Modules 1&2) from:
Course for English speaking students only:
30.05.2024 (Module 1, online) and 06.06.2024 (Module 2, in presence)
Registration required via email to
Online TRREE course:
Instead of courses in presence, there is the possibility to follow the TRREE online modules (1, 2.1, 3.1, 3.2, National Supplement for Switzerland).
For accreditation of the TRREE online modules, certificates have to be handed in to
(certificate for module 3.2 is not for free: CHF 50).
|
No time listed | 16 h semesterly |
Offered In
-
Doctorate Health Sciences and Technology (More Information at: )
-
-
-