Faculty of Medicine | Julius-Maximilians-University Würzburg (JMU) | Institute for Epidemiology & Biometry
This module is part of the certificate ”Digitalisation of Clinical Research and Care”
Teaching Language: German
Workload: 0h presence / 8h online / 172h self-study = 180h total1 (6 ECTS)
Target Group: The course is aimed at senior medical students as well as physicians or medical scientists involved in the implementation and conduct of clinical studies.
Form of teaching: Lecture and final oral examination
Modern clinical studies often generate large amounts of data by using new technologies in the health sector and they must adhere to rigorous quality criteria. Knowledge about the ethical, legal and regulatory requirements regarding planning, performing and analyzing this type of studies is essential for successful research.
The participants in this course will work on practical issues regarding the development and implementation of study designs. They will acquire knowledge in protocol development, trial documents, ethical issues, patient information, data management and establishing trial procedures in multi-center clinical studies.
They will learn the general principles of trial conduct in accordance with Good Clinical Practice and legal requirements (e.g. drug law, medical product law). Podcasts and video lectures on special topics will complement the curriculum. Real-world examples from recent trials will be included as case studies via the online platform CaseTrain. In addition, the participants will acquire special knowledge of design aspects, e.g., sample size calculation.
This course will be run in cooperation with the new study program and master’s program “Translational Medicine” at Julius-Maximilians-University Würzburg supported by the Elite Network of Bavaria.
Bibliography: Pocock "Clinical Trials"
1: The times serve as rough orientation. The real times may differ.