Preferred Label : Trial Event Reporting Method;
NCIt related terms : Method for Reporting;
NCIt definition : The technique by which trial related events, such as adverse events, serious adverse
events, product complaints, medical device product complaints, and pregnancy and postpartum
events, are reported to the sponsor and/or regulatory authority.;
Alternative definition : ICH: A description of the technique by which trial related events, such as adverse
events, serious adverse events, product complaints, medical device product complaints,
and pregnancy and postpartum events, are reported to the sponsor and/or regulatory
authority.;
Codes from synonyms : ICH M11-Section 9;
Origin ID : C218789;
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