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SMPD 287

Informatics in Drug and Device Development

Description
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: Admission to the MPDM program and completion of SMPD 286 and BUS 224C.

Grading
Normal Grade Rules

Units
3