SMPD 287 - Informatics in Drug and Device Development

3 units
Provides business and regulatory perspectives on electronic information technologies, processes and standards in the conduct of clinical trials. Special emphasis: data collection, clinical trial & data management randomization and drug supply, statistical processes, safety databases and electronic regulatory submission, electronic records and signatures, sys validation processes, and data standards.

Prerequisite(s): Admission to the MPDM program and completion of SMPD 286.
Grading: Graded

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