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GCP Basic Course (Modules 1 and 2)
Last Updated: 2026-02-05 15:34:24
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
- MSC
- Frequency
- Yearly 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: Please select courses from:
new dates are published quaterly
For accreditation of TRREE online modules (1, 2.1, 3.1, 3.2, CH-Supplement) certificates (CHF 50.00) have to be handed in to
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Course for English speaking students only:
Registration required: Email:
Dates 2021 for English speaking students: GCP-Module 1: 08.06.2021 / GCP-Module 2: 10.06.2021.
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16 h semesterly |