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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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