376-0302-01L GCP Basic Course (Modules 1 and 2)
| Semester | Spring Semester 2022 |
| Lecturers | G. Senti, C. Fila, R. Grossmann |
| Periodicity | every semester recurring course |
| Language of instruction | English |
| Comment | Only for Health Sciences and Technology MSc. |
Courses
| Number | Title | Hours | Lecturers | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 376-0302-01 G | GCP Basic Course (Modules 1 and 2) Courses for German speaking students: Please select courses from: https://www.usz.ch/veranstaltung/good-clinical-practice-gcp-basiskurs/ 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 claudia.fila@usz.ch. Course for English speaking students only: Registration required: Email: roland.mueller@hest.ethz.ch Dates 2022 for English speaking students: GCP-Module 1: 2.6.2022, Module 2: 9.6.2022 | 16s hrs |
| G. Senti, C. Fila, R. Grossmann |
Catalogue data
| 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. |
| Learning 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 |
Performance assessment
| Performance assessment information (valid until the course unit is held again) | |
Performance assessment as a semester course | |
| ECTS credits | 1 credit |
| Examiners | G. Senti, C. Fila, R. Grossmann |
| Type | ungraded semester performance |
| Language of examination | English |
| Repetition | Repetition only possible after re-enrolling for the course unit. |
Learning materials
| No public learning materials available. | |
| Only public learning materials are listed. |
Groups
| No information on groups available. |
Restrictions
| Priority | Registration for the course unit is only possible for the primary target group |
| Primary target group | Health Sciences and Technology BSc (376000)
Health Sciences and Technology MSc (380000) |
