Module MA2214-KP04, MA2214
Clinical Studies (KlinStud)
Duration
1 Semester
Turnus of offer
each winter semester
Credit points
4
Course of studies, specific fields and terms:
- Bachelor CLS 2023, compulsory, mathematics
- Master Nutritional Medicine 2023, compulsory, medical computer science
- Bachelor Medical Informatics 2019, optional subject, medical computer science
- Bachelor CLS 2016, compulsory, mathematics
- Master Nutritional Medicine 2019, compulsory, medical computer science
- Bachelor Medical Informatics 2014, optional subject, medical computer science
- Master Computer Science 2012, optional subject, specialization field medical informatics
- Bachelor Medical Informatics 2011, optional subject, medical computer science
- Bachelor MES 2011, optional subject, life sciences
- Bachelor CLS 2010, compulsory, mathematics
Classes and lectures:
- Clinical Studies (exercise, 1 SWS)
- Clinical Studies (lecture, 2 SWS)
Workload:
- 45 hours in-classroom work
- 15 hours exam preparation
- 60 hours private studies and exercises
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
- Professional fields in clinical studies (study statistics, data management, monitoring, quality management, pharmacovigilance, project management)
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 relevant parts of 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
Grading through:
- portfolio exam
Responsible for this module:
- Prof. Dr. rer. biol. hum. Inke König
- PD Dr. rer. pol. Reinhard Vonthein
Teacher:
- Institute of Medical Biometry and Statistics
- PD Dr. rer. pol. Reinhard Vonthein
- Prof. Dr. rer. biol. hum. Inke König
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)
- Friedman, L.M., Furberg, C.D., DeMets, D.L., Reboussin, D.M., Granger, C.B. : Fundamentals of Clinical Trials Springer 2015 (5th edition)
Language:
- German and English skills required
Notes:
Admission requirements for taking the module:- None
Admission requirements for participation in module examination(s):
- None
Module exam(s):
- MA2214-L1: Clinical Studies, portfolio exam, 100% of module grade with contributions from written exam (50%) and project work (50%)
Last Updated:
19.09.2025