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Clinical Data Management (CDM)

Module Title: Clinical Data Management

Module No.:

CDM

Semester / Term:

--

Duration:

1 Semester

Module Type(s):

Pflicht

Regularly offered in:

WS, SS

Workload: 150 h

Credit Points: 5

Admission Requirements:

None

Language of Instruction:

Englisch

Contributing Courses to Module:

Workload:

Lectures: 30 h
Self-study: 90h
Self-testing: 30 h

Course Coordinator(s) / Tutor(s):

Module Director:

Simone Prädel

References to Other Programs:

• N/A

References to Other Modules in the Program:

• Statistical Thinking for Clinical Trials
• Conducting Clinical Trials Clinical Data Management

Qualification and Educational Objectives of the Module:

This course is designed to provide an insight into the principles of clinical data management and the role of a clinical data manager within the field of clinical research.

Course Content of the Module:

• Role of a clinical data manager
• Data management process
• Technologies in data management
• Flowchart and CRF design
• Data entry and final database quality control
• Data validation plan
• Discrepancy management and query processing
• Medical coding
• Database lock
• Regulatory requirements and SOP development
• Electronic data capture in practice

Teaching Methods:

See the contributing course outline(s)

Literature:

See the contributing course outline(s)

Percentage of the Module Grade Relative to the Final Grade for the Program:

--

Prerequisites to Qualify for Assessment:

Assessment:

See course outline(s)

Exam, 90 minutes (100%)