" /> Special Safety Situation Type - CISMeF





Preferred Label : Special Safety Situation Type;

NCIt related terms : Special Safety Situations;

NCIt definition : A characterization or classification of those trial specific situations that are associated with the trial intervention(s) and require regulatory reporting, but that do not qualify as an adverse event or serious adverse event for the given trial.;

Alternative definition : ICH: A characterisation or classification of those trial specific situations that are associated with the trial intervention(s) and require regulatory reporting, but that do not qualify as an adverse event or serious adverse event for the given trial.;

Codes from synonyms : ICH M11-Section 9;

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28/07/2025


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