<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-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. 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.</n0:def-definition><n0:def-source>BRIDG</n0:def-source></n0:ComplexDefinition><n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A submission that contains a new annual report, Periodic Adverse Drug Experience Report (PADER) or Periodic Safety Update Report (PSUR).</n0:def-definition><n0:def-source>FDA</n0:def-source><n0:attr>eCTD</n0:attr> </n0:ComplexDefinition>
<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A type of report required by a regulatory agency.</n0:def-definition><n0:def-source>NCI</n0:def-source></n0:ComplexDefinition>