CLRA 6190 – Information and Data Management
The importance of information systems and information technology in increasing efficiencies in the management of clinical research data is examined in this course. The application of legal and ethical principles is considered, with attention to the development of a data collection and management plan that promotes information archiving and access as well as edit and query management. Issues of confidentiality and the security of information systems are addressed. Emerging technology that facilitates the capture and analysis of clinical study results, such as electronic data capture (EDC) and electronic case reporting forms (eCRF), is also examined.
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