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Safety Report
Definition 1
A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject of adverse event, or name of product. (NCI Thesaurus)
Definition 2
A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject of adverse event, or name of product. EXAMPLE(S): An Expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies. (NCI Thesaurus/BRIDG)
Definition 3
Life-threatening, serious and unexpected adverse events as described in 21 CFR 312.32, 600.80 and 314.80 Periodic adverse event report: Post-marketing report required by CFR 600.80 to be submitted quarterly for three (3) years, then annually, upon approval/licensing of vaccine or biologic product. (Food and Drug Administration)
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