Preferred Label : Trial Event Back-Up Reporting Method;
NCIt related terms : Back-up Method for Reporting;
NCIt definition : The alternative techniques 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 alternative techniques 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 : C218790;
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