International comparison of the monitoring systems of drug safety in clinical trials
XU Bo
WANG Yan
Abstract：The differences in monitoring systems for drug adverse event between China and other countries in clinical trials were analyzed. In China, the investigators are responsible to report severe adverse event (SAE) within 24 h. The assessment of relation between events and drug reaction is graded at 5 levels, and should be repor-ted in the format of a severe adverse event form. By the requirement of ICH, adverse drug reaction should be repor-ted by the sponsor within 7 or 15 days. A CIOMS-I form is commonly used for reporting. Currently, insufficient at-tention has been paid to the report of drug adverse events in clinical trials. Thus, the system of safety monitoring in China should be improved, and a better system of safety monitoring as well as the system of drug effect assessment should be established.
Keywords：clinical trialsafety monitoring systemassessment system
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 1291-1293 )