Clinical Research

Course content

Design, proposal and conducting of clinical studies, co-operation of participants (pharmaceutical industry, authorities, ethic commission etc.), ethic issues, IT support of procedures in clinical research, implementation and operation of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) systems, audits, national and international admission procedures, guidelines

Learning outcomes

The students receive a well-founded overview of health topics of the entire population with regard to prevention, health promotion and acute care. They are familiar with the most important regulatory requirements of quality management, which also enable them to work in specialised pharmaceutical and biotechnology companies. They can work in data management within the framework of clinical studies.

Recommended or required reading and other learning resources / tools

Books: Leon Gordis: Epidemiologie, Verlag im Kilian, Marburg 2001, ISBN 3-932091-63-9, Straus et al: evidence based medicine; Kotter: Leading Change; Bonita et al: Einführung in die Epidemiologie, Rothman et al: Modern Epidemiology, Weiß: Basiswissen medizinische Statistik, Kreienbock et al: Epidemiologische Methoden,
Journals: BMJ, Cochrane Library, WHO Report,

Mode of delivery

5 ECTS ILV

Prerequisites and co-requisites

Biostatistics, anatomy basics, pathology basics

Assessment methods and criteria

Lecture: Exam; Tutorial: Continuous Assessment