DH: Clinical Data Management
Course content
Introduction to Clinical Data Management (CDM), CDM flow,
Case report form (CRF) design, Function of the CRF, Procedure for CRF design,
Data capture, Traditional data capture methods, Data from external databases,
Reading optical images data,
Factors affecting data capture,
Remote data entry methods,
Introduction to database design and build, database validation, Quality assurance, and CDM, Audit, Error Metrics,
CDM Training, Computer validation,
Performance measures, status reporting,
Data Presentation, Clinical research issues for data presentation, types of clinical data
Hands-on practice with clinical data loading, database creation, quality control of clinical data
References
Clinical Data Management: 2nd Edition by Richard K. Rondel, Sheila A. Varley, Colin F. Webb
Practical Guide to Clinical Data Management by Susanne Prokscha - Taylor & Francis
Appropriate research articles for each topic will be suggested in class.
Pre-requisite
:
None
Total credits
:
6 credits - Lecture
Type
:
Department elective
Duration
:
Full Semester - To be offered normally in 2
nd
semester
Name(s) of other Academic units to whom the course may be relevant
:
BSBE, Math, CSE, CHE