Examine the elements involved in implementing and monitoring a clinical study from the sponsor's point of view. Topics include finalizing the study materials; site selection; staffing and training; strategies for communicating with sites, regulators, and others; cost management; site initiation; enrollment options; data management set-up and testing; monitoring procedures and training; auditing; safety monitoring; reports; and the Data and Safety Monitoring Board (DSMB).
Other Credits: BRN: 16 CE hours.
Note: Prerequesites: Drug Development Process, Good Clinical Practices, and Human Subjects Protection/IRBS. Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40229
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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1/4/2021 - 3/13/2021