CBER Vaccine ICSR Implementation
CBER is implementing the updated International Conference on Harmonisation’s (ICH) E2B(R3) Individual Case Safety Report (ICSR) specification to support electronic reporting of vaccine postmarketing safety reports as specified in the Electronic Safety Reporting Rule published June 10, 2014. Information about ICSR specifications supported by CBER is available at: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-biologics/electronic-submission-postmarket-safety-reports.
VAERS Electronic Reporting Resources:
FDA E2B(R3) Guidance to Industry:
Electronic Vaccine Adverse Event Reporting System (eVAERS) Guidance:
- FDA ICH E2B(R3) Regional Technical Specifications Document for Vaccine Reporting:
- Appendix A to the FDA ICH E2B(R3) Technical Specifications Document is provided in XML format to demonstrate how FDA regional data elements are accommodated in the XML schema:
Sample ICSR E2B(R3) XML with only value responses:
ICSR E2B(R3) XML with null-flavor in place of values responses:
- Appendix B: Consolidated Business Rules Document - Appendix B has been added to provide more information about eVAERS field lengths and datatypes for FDA regional data elements.
- Appendix C: Test cases scenarios recommended for the Pilot Test.
ATTENTION: FDA is making revisions to the eVAERS technical specification in order to accommodate the FDA Rule “Postmarketing Safety Reporting for Combination Products”, issued on December 20, 2016. In addition, FDA has updated the corresponding eVAERS business rule document and sample XML file(s) which provide additional detail and specific requirements for each data field.
Proposed updates are provided here: http://wcms-internet.fda.gov/vaccines-blood-biologics/vaccines/cber-vaccine-icsr-proposed-updates
Information about Postmarketing Safety Reporting for Combination Products, including the Rule, associated Draft Guidance for Industry and Staff, and Compliance Policy, is available at: https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products