" /> New Safety Information Available Amendment Reason - CISMeF





Preferred Label : New Safety Information Available Amendment Reason;

NCIt related terms : New Safety Information Available;

NCIt definition : Previously unavailable safety data became available, which necessitates a change(s) to, or formal clarification of, the protocol.;

Alternative definition : ICH: Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.;

Codes from synonyms : ICH M11-Reason for Amendment;

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28/07/2025


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