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'ICSR' refers to an Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and submission of suchE2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files. The ICH E2B EWG released an E2B guideline for Maintenance of the ICH Guideline on xml file for the eCTD submission.) d. IND safety reports previously submitted on paper should be attached to the IND safety report as PDF attachments. Table 144 ICH E2B(R3) Implementation Guide and the International ICSR standard ISO/HL7 27953-2:2011 gvp-module-vi-addendum-i-duplicate-management-suspected_en.pdf.

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