摘要
药物临床试验质量控制体系在药物临床试验中起重要作用,其目的在于保证试验过程规范,结果科学可靠,受试者的安全和权益得到保障。我院在长期实践过程中建立了"三方面质量控制"体系,即专业科室质量控制体系、机构办公室质量控制体系、配合申办方项目质量控制体系。目前已对10项注册类和20项非注册类药物临床试验进行了质量核查,保证我院所承接的试验项目数据真实、资料完整。
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.
出处
《儿科药学杂志》
CAS
2013年第4期50-53,共4页
Journal of Pediatric Pharmacy
基金
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
关键词
儿童
临床试验
质量控制
Children
Clinical Trial
Quality Control
