C3889274_NCI_CareLex | Knowledge4COVID-19

Property	Value
?:definition	Notification to Regulatory Authorities of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority\'s approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, Serious Breaches, cover letters and/or country-specific reporting forms. [TMF-RM]
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?:hasGeneratedBy	<https://research.tib.eu/covid-19/SourceName/NCI_CareLex>
?:type	<https://research.tib.eu/covid-19/vocab/AnnotationDefinition>

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