" /> Event Reporting Procedure Description - CISMeF





Preferred Label : Event Reporting Procedure Description;

NCIt related terms : Reporting;

NCIt definition : A description of the method and timelines for reporting events such as adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints to the sponsor.;

Alternative definition : ICH: A description of the method and timelines for reporting adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints to the sponsor.;

Codes from synonyms : ICH M11-Section 9;

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28/07/2025


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