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45395-01 - Vorlesung: Good Clinical Practice 1 KP

Semester Herbstsemester 2020
Angebotsmuster Jedes Herbstsemester
Dozierende Christian Burri (christian.burri@unibas.ch, BeurteilerIn)
Inhalt Compact two day introductory course to the Good Clinical Practice guideline (GCP) designed according to the requirements of Swissethics (level of investigators and sub-investigators).
The course provides a compact insight into the ICH E6 GCP regulation and related topics. It is ideal for Investigators, study personnel and people involved and/or interested in clinical research. It serves as beginners as well as refresher training.

Content: Principles of the ICH-GCP guideline and its historical background; Legal and regulatory requirements of clinical research; Role of ethics committees and regulatory authorities; Quality and data management in clinical trials; Study documentation, incl. structure and content of study protocol; Study design and basic statistical principles.
Lernziele Understanding the basic principles of research involving humans
Knowing the fundamental principles of Good Clinical Practice
Literatur Mandatory reading: Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Version 2015 (http://www.wma.net/en/30publications/10policies/b3/)
Optional reading: Guideline ICH E6 Good Clinical Practice (http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html)
Bemerkungen A certificate of participation will be handed out

Film and sound recordings during the course are strictly forbidden (recorders may be confiscated)


Anmeldung zur Lehrveranstaltung The seminar is fully booked!
Unterrichtssprache Englisch
Einsatz digitaler Medien kein spezifischer Einsatz


Intervall Block
Datum 14.01.2021 – 15.01.2021
Zeit Siehe Detailangaben


Datum Zeit Raum
Donnerstag 14.01.2021 08.00-17.00 Uhr Kollegienhaus, Aula 033
Freitag 15.01.2021 08.00-17.00 Uhr Kollegienhaus, Aula 033
Module Modul: Clinical Drug Development: the Basis for Market Approval (Masterstudium: Drug Sciences)
Leistungsüberprüfung Lehrveranst.-begleitend
Hinweise zur Leistungsüberprüfung Complete participation and 70% correct answers at the Multiple choice test (self-checking of acquired knowledge) at the end of the seminar
An-/Abmeldung zur Leistungsüberprüfung An-/Abmelden: Belegen resp. Stornieren der Belegung via MOnA
Wiederholungsprüfung keine Wiederholungsprüfung
Skala Pass / Fail
Wiederholtes Belegen beliebig wiederholbar
Zuständige Fakultät Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch
Anbietende Organisationseinheit Departement Pharmazeutische Wissenschaften