376-0302-01L  GCP Basic Course (Modul 1 and 2)

SemesterHerbstsemester 2017
DozierendeG. Senti
Periodizitätjährlich wiederkehrende Veranstaltung
LehrspracheEnglisch
KommentarNur für Gesundheitswissenschaften und Technologie MSc.


KurzbeschreibungThe 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.
LernzielStudents 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
InhaltModule 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