Search result: Catalogue data in Autumn Semester 2018

Health Sciences and Technology Master Information
Major in Medical Technology
Compulsory Courses
NumberTitleTypeECTSHoursLecturers
376-0300-00LTranslational Science for Health and Medicine Restricted registration - show details O3 credits2GJ. Goldhahn, C. Wolfrum
AbstractTranslational science is a cross disciplinary scientific research that is motivated by the need for practical applications that help people. The course should help to clarify basics of translational science, illustrate successful applications and should enable students to integrate key features into their future projects.
ObjectiveAfter completing this course, students will be able to understand:
Principles of translational science (including project planning, ethics application, basics of resource management and interdisciplinary communication)
ContentWhat is translational science and what is it not?
How to identify need?
- Disease concepts and consequences for research
- Basics about incidence, prevalence etc., and orphan indications
How to choose the appropriate research type and methodology
- Ethical considerations including ethics application
- Pros and cons of different types of research
- Coordination of complex approaches incl. timing and resources
How to measure success?
- Outcome variables
- Improving the translational process
Challenges of communication?
How independent is translational science?
- Academic boundary conditions vs. industrial influences
Positive and negative examples will be illustrated by distinguished guest speakers.
376-0302-01LGCP Basic Course (Modul 1 and 2) Restricted registration - show details
Only for Health Sciences and Technology MSc.
O1 credit1GG. Senti
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.
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
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