C3899591_NCI_CareLex | Knowledge4COVID-19

Property	Value
?:definition	Documentation that presents and summarizes the relevant findings and notification by the sponsor of unexpected serious adverse drug reactions and other safety information, which is submitted to regulatory authorities, investigators, Institutional Review Boards (IRBs) and/or Independent Ethics Committees (IECs). Reports may include but are not limited to CIOMS, MedWatch, Electronic Submission of AE Notification to FDA Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting forms. [Adapted from TMF-RM]
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?:type	<https://research.tib.eu/covid-19/vocab/AnnotationDefinition>

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