A Method for the Detection and Management of Adverse Events in Clinical Trials

摘要: This paper describes a systematic approach to the detection, classification, and documentation of adverse events in multicenter clinical trial. The system is designed minimize investigator prejudgment, capture infrequent or unexpected effects, track concurrent events, allow for comparison effects across centers. method employs standard questionnaire, which records health status symptomatology patient at study entry as well follow-up visits comparison. A systems review, detect emerging changing symptoms, also included. association drug classified according criteria. All whether not judged be related, are recorded. Dose modifications prescribed documented each visit until event resolved. combines methodology with continuous monitoring provide comprehensive managing event...