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

SemesterSpring Semester 2022
LecturersG. Senti, C. Fila, R. Grossmann
Periodicityevery semester recurring course
Language of instructionEnglish
CommentOnly for Health Sciences and Technology MSc.


AbstractThe 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 objectiveStudents 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
ContentModule 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