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U.S. Department of Health and Human Services

For Industry

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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

The FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting provides information about electronic Individual Case Safety Report (ICSR) submissions to the Vaccine Adverse Event Reporting System.
  • Appendix A to the FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting

Appendix A provides a regional XML instance example which includes the FDA regional data elements for vaccine reporting

An XML file is also provided to help orient XML programmers to the specific ICSR schema processing requirements.