This presentation defines adverse event and serious adverse events. It provides specific guidance for documenting an event correctly. This module provides regulatory guidance for determining if an event is reportable under 45 CFR Part 46. In addition, it discusses what, when, and how to report events to the FDA, sponsor, funding agency,, and the DUHS IRB.

Loading... Loading...
You have selected an option that triggers this survey to end right now. To save your responses and end the survey, click the button below to do so. If you have selected the wrong option by accident and do not wish to leave the survey, you may click the other button below to continue, which will also remove the value of the option you just selected to allow you to enter it again and continue the survey.
The response has now been removed for the last question for which you selected a value. You may now enter a new response for that question and continue the survey.