DYNAMIC SAFETY MONITORING IN CLINICAL TRIAL

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.