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DYNAMIC SAFETY MONITORING IN CLINICAL TRIAL
DYNAMIC SAFETY MONITORING IN CLINICAL TRIAL
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机译:临床试验中的动态安全监控
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摘要
A dynamic safety reporting system for clinical trials in which members of an initial review team are sent dossiers describing patient events in a clinical trial as the dossiers are generated. The initial review team can be required to complete the review within a predetermined time period, and disagreements among initial review team members can be referred to a follow-up review team. Case reports that include the results of the review can be stored in database.
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