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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

AttributesValues
rdf:type
rdfs:label
  • Safety Report
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Safety Report
NCI_META_CUI
  • CL425320
Contributing_Source
  • BRIDG
  • FDA
ALT_DEFINITION
  • 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.FDAeCTD
  • 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.BRIDG
FULL_SYN
  • Safety ReportPTNCI
  • Safety ReportsPTFDA
  • SafetyReportVersionPTBRIDG
DEFINITION
  • 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
code
  • C93488
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