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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
  • Regulatory Report
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Regulatory Report
NCI_META_CUI
  • CL429677
Contributing_Source
  • FDA
ALT_DEFINITION
  • A submission that contains a new annual report, Periodic Adverse Drug Experience Report (PADER) or Periodic Safety Update Report (PSUR).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
  • Regulatory ReportPTNCI
  • ReportPTFDA
DEFINITION
  • A type of report required by a regulatory agency.NCI
code
  • C97107
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