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U.S. Department of Health and Human Services

For Industry

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ICSR Reporting to VAERS

As of August 2012, OBE has launched an eSubmitter pilot evaluation program for select participants in support of vaccine Individual Case Safety Reports (ICSR) Adverse Event Reporting to VAERS. Pilot participants will test the CBER ICSR template, which is based upon the ISO/HL7 27953-2 conformance specification for the International Conference on Harmonisation's (ICH) Clinical Safety Data Management E2B(R3) Guideline: Data Elements for Transmission of Individual Case Safety Reports. Following the pilot evaluation period, the CBER ICSR submission type will be made available to all industry sponsors.

If you have any questions about the CBER ICSR pilot or need additional assistance with eSubmitter, please send an email to: CBER_eSubmitter_program@fda.hhs.gov