376-0302-01L GCP Basic Course (Modules 1 and 2)
| Semester | Frühjahrssemester 2024 |
| Dozierende | G. Senti, C. Fila, R. Grossmann |
| Periodizität | jedes Semester wiederkehrende Veranstaltung |
| Lehrsprache | Englisch |
Lehrveranstaltungen
| Nummer | Titel | Umfang | Dozierende | |
|---|---|---|---|---|
| 376-0302-01 G | 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: https://www.usz.ch/veranstaltung/good-clinical-practice-gcp-basiskurs/ 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 roland.mueller@hest.ethz.ch 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 claudia.fila@usz.ch (certificate for module 4 is not for free: CHF 50). | 16s Std. | G. Senti, C. Fila, R. Grossmann |
Katalogdaten
| Kurzbeschreibung | 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. |
| Lernziel | 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 |
| Inhalt | 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 |
Leistungskontrolle
| Information zur Leistungskontrolle (gültig bis die Lerneinheit neu gelesen wird) | |
Leistungskontrolle als Semesterkurs | |
| ECTS Kreditpunkte | 1 KP |
| Prüfende | G. Senti, C. Fila, R. Grossmann |
| Form | unbenotete Semesterleistung |
| Prüfungssprache | Englisch |
| Repetition | Repetition nur nach erneuter Belegung der Lerneinheit möglich. |
Lernmaterialien
| Keine öffentlichen Lernmaterialien verfügbar. | |
| Es werden nur die öffentlichen Lernmaterialien aufgeführt. |
Gruppen
| Keine Informationen zu Gruppen vorhanden. |
Einschränkungen
| Vorrang | Die Belegung der Lerneinheit ist nur durch die primäre Zielgruppe möglich |
| Primäre Zielgruppe | Gesundheitswissenschaften und Technologie BSc (376000)
Gesundheitswissenschaften und Technologie MSc (380000) Doktorat Gesundheitswissenschaften und Technologie (389000) Doktorat Gesundheitswiss. und Technologie ETH-UZH (390000) |
