Clinical Epidemiology I – Part 1: Medical Informatics and Regulatory Issues in Clinical Research

The course is divided into two thematic units – medical informatics and regulatory issues in clinical trials. In the Medical Informatics part, it provides an overview on basic information processing, the internet, database and medical information systems. It covers also topics related to legal foundations of confidentiality and patient privacy as well as security of information. Other important aspects discussed in the first part are representation and standardisation of medical knowledge, development and implementation of information systems and specific requirements for systems used in quality management of clinical research. In the Regulatory Issues in Clinical Trials part, students learn about the crucial regulatory issues in the clinical studies, such as legal foundation, good clinical practice guidelines, compilation of study protocol, ethical aspects, quality management, data management and reporting standards for study results. In addition the course covers regulations related to prognosis and diagnosis studies as well as pharmaceutical drug safety and pharmacoepidemiology.


Prerequisites: none

Type of examination: Written exam

Course coordinator: Prof. Dr. Eva Hoster

When: winter semester

If you are interested, you can download a booking form from the student cloud which you fill in and submit to the MSc team.

Detailed information about the courses can be obtained from the MSc team: msc@ibe.med.uni-muenchen.de