Evaluating the evaluators - Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicators, and direct measure of high risk errors.

导出 LinkOut

翻译打印收藏纠错

第一作者： Penelope,Manasco

第一单位： MANA RBM, United States of America. Electronic address: pmanasco@manarbm.com.

作者： Penelope,Manasco ^[1] ; Deepak L,Bhatt ^[2]

作者单位： MANA RBM, United States of America. Electronic address: pmanasco@manarbm.com. ^[1] Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis Street, Boston, MA 02115, United States of America. Electronic address: DLBhattMD@post.Harvard.edu. ^[2]

关键词 Clinical trial quality Risk based monitoring Risk based quality management Source data verification Trial oversight

主题词人类(Humans);危险因素(Risk Factors);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1016/j.cct.2022.106764

PMID 35436623

发布时间 2022-08-22

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交