This course provides the foundation for monitoring clinical trials. Topics include roles and responsibilities of the sponsor and investigator site defined by the FDA and applied to monitoring activities from study start-up to completion. Study site selection, initiation, interim monitoring, and closeout procedures are reviewed. Regulatory documents, source documents, safety reporting of adverse events, study drug accountability, and compliance are reviewed. Principles of investigator grant budget, contract, and payment are also reviewed.
Class will not meet 11/11, 11/24, or 11/25
|Refund Code||Full Refund||75% Refund||No Refund|
|CEL_1||Class dropped one day prior to class start day||N/A||Class dropped on or beyond class start day|
Last Update: Aug 11, 2022 10:49am