Informatics in Drug and Device Development
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.
Normal Grade Rules