Preferred Label : Regulatory Reporting Requirements for Trial-Related Events;
NCIt related terms : Regulatory Reporting Requirements;
NCIt definition : The requirements for the sponsor/designee to report adverse events, serious adverse
events, pregnancy and postpartum events, and medical device product complaints, including
the criteria for reporting, to the relevant regulatory authority.;
Alternative definition : ICH: A description of the requirements for the sponsor/designee to report adverse
events, serious adverse events, pregnancy and postpartum events, and medical device
product complaints, including the criteria for reporting, to the relevant regulatory
authority.;
Codes from synonyms : ICH M11-Section 9;
Origin ID : C218796;
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