Скачать или смотреть Adverse Events and Safety Reporting - Single Patient Expanded Access

There are risks to every treatment, and sometimes a patient will experience negative effects - an adverse event - from an investigational product through Expanded Access. It is important for physicians to report these events to the appropriate authorities. This video describes the classifications of adverse events and when reporting is required.

Expanded Access is the FDA (‪@US_FDA‬) pathway that allows the clinical use of investigational products for patients who have serious or life threatening illnesses and no comparable or satisfactory therapeutic options.

Chapters:
00:00 FDA Resources
00:22 What is an adverse event?
00:37 Serious Adverse Events
01:32 Related versus Unrelated Events
02:11 Serious AND Related Events
02:31 Expected versus Unexpected Events
03:10 SUSARs: Suspected, Unexpected, Serious Adverse Reactions
03:46 How to report an adverse event

More resources for Expanded Access are available at TransformingExpandedAccess.org.

This video was produced by Transforming Expanded Access to Maximize Support and Study (TEAMSS), sponsored by the National Center for Advancing Translational Science (‪@NCATSMedia‬) grant U01 TR002488.