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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.

ECTS: 6

Prerequisites: None

Type of examination: Written exam

Course coordinator: Prof. U. Mansmann

When: Winter Semester (Jan) – two week course

How to register? Please contact the PhD program Office phd@ibe.med.uni-muenchen.de

Course Structure

Seminars – Presentation of specific topics based on published studies, methodological papers, and data sets with related publications. Students will become familiar with the topic background (methods and field of application, how to implement guidelines) and discuss the possibilities of implementation of the new methods to their own work.

Tutorials/Exercise – With help of exercises and small projects, students learn how to apply guidelines in the analysis of clinical studies, and how quality assurance influences the processes a biostatistician has to implement. Students should not only obtain the ability to simply use the new methods on their own, but also to understand how they have to fit into an overall ELSI framework (ethical, legal, social issues).