" /> New Data Available (Other Than Safety Data) Amendment Reason - CISMeF





Preferred Label : New Data Available (Other Than Safety Data) Amendment Reason;

NCIt related terms : New Data Available (Other Than Safety Data);

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

Alternative definition : ICH: Previously unavailable data (other than 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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Keyword's position in hierarchy(ies) : arborescence

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15/08/2025


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