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GCP Basic Course (Modules 1 and 2)
Last Updated: 2026-02-05 16:29:12
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 quarterly.
Please select courses (GCP Modules 1&2) from:
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Course for English speaking students only:
27.05.2025 (Module 1, online) and 05.06.2025 (Module 2, in presence)
Registration required via email to
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Online TRREE course:
Instead of courses in presence, there is the possibility to follow the TRREE online modules (1, 2, 3, 4 and Regulatory Framework of Switzerland).
For accreditation of the TRREE online modules, certificates have to be handed in to
(certificate for module 4 is not for free: CHF 50).
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No time listed | 16 h semesterly |
Offered In
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Doctorate Health Sciences and Technology (More Information at: )
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