Collection, monitoring and evaluation of safety data is a key responsibility of the Sponsor and Investigator and the first goal listed by the FDA. Adverse events and serious adverse events are key data elements to review the safety of a product. An adverse event is defined as an untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. This course will introduce you to common safety monitoring practices and the regulatory reporting responsibilities for medical products.
|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