Clinical Data Management (CDM)
Kursnummer: CDM |
Kursname: Clinical Data Management |
Gesamtstunden: 150 h |
ECTS Punkte: 5 ECTS |
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Kurstyp: Pflicht Kursangebot : WS, SS Course Duration : 1 Semester |
Zugangsvoraussetzungen: None |
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Kurskoordinator(en) / Dozenten / Lektoren: Siehe aktuelle Liste der Tutoren im Learning Management System |
Bezüge zu anderen Modulen: Siehe Modulbeschreibung |
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Beschreibung des Kurses: The course covers key elements of the data management process, such as CRF design, data entry, data validation, and medical coding as well as exploring the relevant regulatory requirements. The course also provides an overview on different technologies used in clinical trials, and enables students to assess criteria for selection based on the requirements of a study. Course Objectives and Outcome: On successful completion of this module, students will be able to
Teaching Methods: This course is taught in blended format. It consists of 120 h directed, remote learning (via recorded presentations, self-readings, and exercises), followed by 4 days of full-time, face-to-face training in form of lectures, supplemented by class discussions. Class discussions refer to the concepts being introduced and case studies. Course Content: 1 Role of a Clinical Data Manager 2 Data Management Process 3 Technologies in Data Management 4 Flowchart and CRF Design 5 Data Entry and Final Database Quality Control 6 Data Validation Plan 7 Discrepancy Management and Query Processing 8 Medical Coding 9 Database Lock 10 Regulatory Requirements and SOP Development 11 Electronic Data Capture in Practice |
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Literatur: • Prokscha, S. (2011). A practical guide to clinical data management (3rd ed.). Boca Raton, FL: CRC Press, 2011 |
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Prüfungszugangsvoraussetzung: • Course evaluation |
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Prüfungsleistung: • Ongoing self-assessments. Students are expected to develop or evaluate multifaceted scenarios, preferably in group sessions where immediate feedback will be provided. |
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Student Workload (in hours): 150 Lectures: 30 |