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- NCIT_C93488 IAO_0000115 "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." @default.
- NCIT_C93488 NCIT_NHC0 "C93488" @default.
- NCIT_C93488 NCIT_P106 "Intellectual Product" @default.
- NCIT_C93488 NCIT_P108 "Safety Report" @default.
- NCIT_C93488 NCIT_P207 "C2985698" @default.
- NCIT_C93488 NCIT_P322 "BRIDG" @default.
- NCIT_C93488 NCIT_P322 "FDA" @default.
- NCIT_C93488 NCIT_P325 "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. OTHER NAME(S): NOTE(S):" @default.
- NCIT_C93488 NCIT_P325 "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." @default.
- NCIT_C93488 NCIT_P325 "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." @default.
- NCIT_C93488 normalizedInformationContent "100" @default.
- NCIT_C93488 referenceCount "1" @default.
- NCIT_C93488 hasExactSynonym "Safety Report" @default.
- NCIT_C93488 hasExactSynonym "Safety Reports" @default.
- NCIT_C93488 hasExactSynonym "SafetyReportVersion" @default.
- NCIT_C93488 inSubset NCIT_C159501 @default.
- NCIT_C93488 inSubset NCIT_C159503 @default.
- NCIT_C93488 inSubset NCIT_C97181 @default.
- NCIT_C93488 inSubset NCIT_C97190 @default.
- NCIT_C93488 type Class @default.
- NCIT_C93488 isDefinedBy ncit.owl @default.
- NCIT_C93488 label "Safety Report" @default.
- NCIT_C93488 subClassOf NCIT_C19498 @default.
- NCIT_C93488 subClassOf NCIT_C20181 @default.
- NCIT_C93488 subClassOf NCIT_C25198 @default.
- NCIT_C93488 subClassOf NCIT_C25375 @default.
- NCIT_C93488 subClassOf NCIT_C93488 @default.
- NCIT_C93488 subClassOf NCIT_C97331 @default.