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| safety monitoring ： ウィキペディア英語版 |
safety monitoring
Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution.
Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. Oversight of the monitoring activity is the responsibility of the sponsor.
==See also==
*Clinical monitoring
*Data Monitoring Committee
*Serious adverse event (SAE)
*U.S. Food and Drug Administration (FDA)
*European Medicines Agency
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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