Gamet J E
United States Food and Drug Administration, New Orleans Investigations Branch, Louisiana 70122, USA.
Qual Assur. 1995 Mar;4(1):12-9.
An overview is presented of the U.S. FDA Bioresearch Monitoring Program from the field perspective. The presentation includes current insight as to how FDA conducts field audits in various program areas and observations regarding shared responsibilities for ensuring both quality data and patient safety during the preclinical and clinical investigation processes.
本文从实际操作角度对美国食品药品监督管理局（FDA）的生物研究监管计划进行了概述。介绍了FDA在各个计划领域开展现场审核的当前情况，以及在临床前和临床研究过程中确保高质量数据和患者安全方面的共同责任的观察结果。
