| Information |
This course will not take place due to low number of participants. |
| Dozent/in |
Dr. rer. pol. Dirk Lehnick |
| Veranstaltungsart |
Masterseminar |
| Code |
HS231194 |
| Semester |
Herbstsemester 2023 |
| Durchführender Fachbereich |
Gesundheitswissenschaften |
| Studienstufe |
Master |
| Termin/e |
|
| Weitere Daten |
Major Course for MSc Health Sciences students. |
| Umfang |
2 Semesterwochenstunden |
| Inhalt |
Clinical Trials:
• Interventional vs. non-interventional studies
• Trials involving medicinal products / Phases of drug development
• Study objectives
• Typical study designs
• Randomization, blinding, study documentation, sample size determinationGood Clinical Practice (GCP) and Research Ethics:
• Ethical principles for research
• History of clinical research ethics (incl. case studies)
• Good Clinical Practice guidelines / legal framework
• Roles, tasks and responsibilities in clinical studies as defined by ICH-GCP
• Patient information and consent
• Clinical trial application / Ethics committees / Competent authorities
• Scientific requirements and practical implementation issues
• Quality management in clinical trials
• Patient information and consent
• Data collection and handling / Statistical planning and analysis
• Adverse events and safety reporting |
| Schlagworte |
Gender/Diversity |
| Lernziele |
• Gain basic knowledge of principles of clinical trials
• Understand the historical context and main concepts of research ethics and Good Clinical Practice (GCP) guidelines
• Know roles, tasks and responsibilities in clinical studies as defined by ICH-GCP |
| Voraussetzungen |
Diligence and eagerness to learn. |
| Sprache |
Englisch |
| Begrenzung |
priority Master Health Sciences students |
| Anmeldung |
https://elearning.hsm-unilu.ch/course/view.php?id=653 |
| Prüfung |
The course credits will be earned by passing a written exam in at the end of the semester or, in case of failure of the written test, the passing of a compensation test during the subsequent semester. |
| Abschlussform / Credits |
written exam / 3 Credits
|
| Hinweise |
Teaching method(s):
The module mainly consists of in-class teaching complemented by practical learning sessions and problem discussions. In-class teaching sessions will be electronically available for recapitulation. Parts of the course will be require self-study conducted between in-class lectures based upon case studies and documents which will be electronically available or will be handed out during the sessions. |
| Hörer-/innen |
Nein |
| Kontakt |
dirk.lehnick@unilu.ch |
| Material |
All teaching material incl. case studies will be provided via the learning management system or as handout. |
| Literatur |
Swiss Academy of Medical Sciences (SAMS) handbook “Research with human subjects” (2nd edition, 2015)Emanuel et al. (2000) What makes clinical research ethical; JAMA 283(20):2701-2711ICH GCP Guideline with Integrated Addendum E6(R2), Step 4 (Nov 2016) |