| MEDI Conception and Evaluation of Medical Studies | Course | INF | |
|---|---|---|---|
| Lecturers : |
Dr. Julian Struck
|
Term | 5 |
| Course Classification : | Bachelor Medizininformatik, Katalog B-MED-INF Wahlpflicht | CH | 4 |
| Language : | Deutsch | Type | VÜ |
| Type of examination : | PL | Credits | 5 |
| Method of evaluation : | term paper with oral examination | ||
| Requirements : | |||
| Cross References : | |||
| Previous knowledges : | Basic knowledge of medical biometrics and statistics | ||
| Aids and special features : | |||
| Teaching aims : | Knowledge: * Students can describe the tasks of medical informatics in the planning and evaluation of medical studies. * Students can define the principles of Good Clinical Practice. Understanding: * Students know the quality criteria of clinical studies and can recognize and discuss these in context. * Students can plan, conduct and evaluate a medical literature search under supervision. * Students can describe the basic medical and health economic aspects of cancer screening programs. Apply: * Students will be able to apply statistical evaluation methods in the context of clinical trials. | ||
| Contents : | * Development of medical questions according to the principles of evidence-based medicine * Selection and design of an adequate study design * Determining the interfaces of the participating study partners * Find external evidence and be able to subject it to quality control * Know literature search strategies and be proficient in database searches * Basics of data collection and data management * Set up a study database * Basics of the statistical analysis of study data * Exemplary implementation using an mRNA-based blood test for early cancer detection Additional content: * Organizational and legal requirements at the study site * Dealing with adverse events * Quality management for studies according to the AMG * International ethical guidelines such as the Declaration of Helsinki | ||
| Literature : | Gaus, Chae: Klinische Studien: Regelwerke, Strukturen, Dokumente, Daten, 2. Auflage, DVMD, 2008. Koch: Untersuchungen zur Früherkennung - Krebs: Nutzen und Risiken. Schumacher, Schulgen: Methodik klinischer Studien, 3. Auflage, Springer, Berlin. Guideline for Good Clinical Practice (ICH-GCP): Vickers: What is a p-value anyway?, Pearson-Verlag. Harms: Biomathematik, Statistik und Dokumentation, Huber-Verlag. Bonita, Beaglehole, Kjellström: Epidemiologie in der Epidemiologie, 3. Auflage, Huber. Gordis: Epidemiology, Elsevier. Straus et al.: Evidence-based Medicine, 5. Auflage. Goggon, Rose & Parker: Epidemiology for the uninitiated (Elektronisches Lehrbuch, frei verfügbar) | ||