Good Clinical Practice

Dozent/in	Dr. rer. pol. Dirk Lehnick
Veranstaltungsart	Masterseminar
Code	HS211021
Semester	Herbstsemester 2021
Durchführender Fachbereich	Gesundheitswissenschaften
Studienstufe	Master
Termin/e	Do, 07.10.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 14.10.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 21.10.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 28.10.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 04.11.2021, 14:15 - 16:00 Uhr, ZOOM Do, 04.11.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 11.11.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 18.11.2021, 16:15 - 18:00 Uhr, ZOOM Do, 25.11.2021, 14:15 - 16:00 Uhr, 3.B58 Do, 02.12.2021, 14:15 - 16:00 Uhr, ZOOM Do, 09.12.2021, 14:15 - 16:00 Uhr, ZOOM Do, 16.12.2021, 14:15 - 16:00 Uhr, ZOOM Do, 23.12.2021, 14:15 - 16:00 Uhr, ZOOM Do, 27.01.2022, 10:30 - 12:00 Uhr, Digitale Prüfung (Prüfung) Mi, 08.06.2022, 14:00 - 15:30 Uhr, HS 4 (Wiederholungsprüfung)
Weitere Daten	Mandatory Basic 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 determination Good 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
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=434
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	Ja
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):2701-2711 ICH GCP Guideline with Integrated Addendum E6(R2), Step 4 (Nov 2016)