Serious Adverse Event Reporting

NIH/OHSR/OBA:

• Office of Human Subjects Research (OHSR) - Adverse Event Reports
• Office of Biotechnology Activities (OBA)

FDA/Regulatory:

• MedWatch - Home
• MedWatch - Mandatory Reporting
• MedWatch - Voluntary Reporting
• Vaccine Adverse Event Reporting System (VAERS)

Sponsor:

• NCI Expedited Reporting Guidelines
• AdEERS - Home
• AdEERS - Application