CBER ICSR Implementation
CBER is implementing the updated ICH E2B(R3) specification to support electronic submission of vaccine Individual Case Safety Reports (ICSR)s to the Vaccine Adverse Event Reporting System (VAERS). Industry participants interested in conducting pilot testing should contact Lise Stevens at: Lise.Stevens@fda.hhs.gov.
To assist industry with preparing for vaccine electronic submissions, the following resources are available:
FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting
Appendix A to the FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting