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376-0302-01L 1 Credits DR , MSC D-HEST
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GCP Basic Course (Modules 1 and 2)

Lecturers & Examiners: PD Dr. Gabriela Senti, Dr. Claudia Fila, Dr. Regina Grossmann
Only for Health Sciences and Technology MSc.
VVZ CR n/a

Last Updated: 2026-02-05 16:02:02

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

Priority: Registration for the course unit is only possible for the primary target group

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 online modules (1, 2.1, 3.1, 3.2, CH-Supplement) certificates (CHF 50.00) have to be handed in to . Course for English speaking students only: registration required via email to Dates 2023 for English speaking students: GCP-Module 1: Tue, 6.6.2023, GCP-Module 2: Thu, 8.6.2023
No time listed 16 h semesterly

Offered In