Duration:
1 Semester | Turnus of offer:
each winter semester | Credit points:
4 |
Course of studies, specific field and terms: - Bachelor CLS 2023 (compulsory), mathematics, 3rd or 5th semester
- Master Nutritional Medicine 2023 (compulsory), medical computer science, 1st semester
- Bachelor Medical Informatics 2019 (optional subject), medical computer science, 4th to 6th semester
- Bachelor CLS 2016 (compulsory), mathematics, 3rd or 5th semester
- Master Nutritional Medicine 2019 (compulsory), medical computer science, 1st semester
- Bachelor Medical Informatics 2014 (optional subject), medical computer science, 5th or 6th semester
- Master Computer Science 2012 (optional subject), specialization field medical informatics, 3rd semester
- Bachelor Medical Informatics 2011 (optional subject), medical computer science, 4th to 6th semester
- Bachelor MES 2011 (optional subject), life sciences, 3rd or 5th semester
- Bachelor CLS 2010 (compulsory), mathematics, 3rd or 5th semester
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Classes and lectures: - Clinical Studies (exercise, 1 SWS)
- Clinical Studies (lecture, 2 SWS)
| Workload: - 60 Hours private studies and exercises
- 15 Hours exam preparation
- 45 Hours in-classroom work
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Contents of teaching: | - Definition of a clinical study according to the German Drug Law, classification of clinical studies, clinical development
- Basic principles of clinical trials and measures against bias
- Regulations and study documents
- Development of a clinical study, especially a study protocol
- Contents of a study protocol
- Link to health economics
- Further topics like
- Special study designs
- Advanced statistical analyses
- Report and publication
- Systematic overview and meta-analyses
- Data management and system validation
- Professional fields in clinical studies (study statistics, data management, monitoring, quality management, pharmacovigilance, project management)
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Qualification-goals/Competencies: - Students can describe the regulatory framework of clinical trials with drugs.
- They can describe the main areas of activity in the fields of study statistics, data management, monitoring, information technology and quality assurance.
- They can explain the basic principles of clinical trials and measures to achieve these basic principles.
- They can create a study protocol.
- They can represent study populations descriptively.
- They can perform case number planning for simple clinical studies.
- Students can assign studies and their key points to the stages of clinical development.
- They can explain different study designs.
- They are informed about ethical problems and guidelines and the principles of data protection.
- Acquisition of german and english technical language
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Grading through: |
Requires: |
Responsible for this module: Teachers: |
Literature: - Gaus W., Chase D.: Klinische Studien: Regelwerke, Strukturen, Dokumente und Daten - Norderstedt: Books on Demand GmbH 2007 (2. Auflage)
- Stapff M.: Arzneimittelstudien - Eine Einführung in klinische Prüfungen für Ärzte, Studenten, medizinisches Assistenzpersonal und interessierte Laien - Germering/München: W. Zuckschwerdt Verlag GmbH 2008 (5. Auflage)
- Schumacher, M., Schulgen, G.: Methodik klinischer Studien: Methodische Grundlagen der Planung, Durchführung und Auswertung - Berlin: Springer 2008 (3. Auflage)
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Language: - German and English skills required
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Notes:Admission requirements for taking the module:
- None (The competencies of the modules listed under 'Requires' are needed for this module, but are not a formal prerequisite)
Admission requirements for participation in module examination(s):
- None
Module exam(s):
- MA2214-L1: Clinical Studies, portfolio exam, 100 % of module grade, with a total of 200 points, distributed as follows:
+ 145 points for project work with documentation and presentations
+ 55 points for 5 short term papers
The course is held annually in German and English alternately. Languages Englisch or German may be chosen for homework and project with
documentation and presentation. |
Letzte Änderung: 19.9.2024 |
für die Ukraine