儿科药学杂志2013，Vol.19Issue(4)：50-53,4.
我院儿童药物临床试验质量控制体系的建设
The Construction of "Quality Control" System of Children' s Drug Clinical Trials in Our Hospital
摘要
Abstract
The drug clinical trial quality control system plays an important role in drug clinical trial. Its goal is to ensure that the process is normative, the result is scientific and reliable, and the participants' safety and rights are guaranteed. We have established "quality control" system through long-term practice in three aspects, quality control system of clinical department, quality control system of drug clinical trial institution office and quality control system of coorperating with bidders' projects. We have verified ten registered items and twenty unregistered items, to ensure that the clinical trials undertaken by our hospital have real data and integrity documents.关键词
儿童/临床试验/质量控制Key words
Children/ Clinical Trial/ Quality Control分类
医药卫生引用本文复制引用
张艳菊,王晓玲..我院儿童药物临床试验质量控制体系的建设[J].儿科药学杂志,2013,19(4):50-53,4.基金项目
科技部"重大新药创制"科技重大专项"十二五"实施计划,项目编号 2011ZX09302-007-01. （）
