Safety Report - CISMeF

Preferred Label : Safety Report;

NCIt related terms : SafetyReportVersion; Safety Reports;

NCIt 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.;

Alternative definition : FDA: 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.; BRIDG 3.0.3: 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 5.3: 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):;

Origin ID

C93488;

UMLS CUI

C2985698;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- BRIDG Class Terminology [NCIt concept]
- BRIDG Terminology [NCIt concept]
- FDA eCTD Terminology [NCIt concept]
- eCTD Submission Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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