参考文献

参考文献

[1]国家食品药品监督管理总局.国家药监局和国家卫生健康委关于发布药物临床试验质量管理规范的公告[R/OL].(2017)[2019-10-28].http://www.nmpa.gov.cn/WS04/CL2097/318606.html.

[2]王佳楠,钱雪,李见明.药物临床试验数据核查工作及常见问题分析[J].中国新药杂志,2018,27(11):15.

[3]赵同香,马丽萍,王海英,等.药物临床试验项目实施过程中常见问题与应对策略[J].中国现代医生,2017,55(8):146-148.

[4]FDA.What is a classification,inspections database frequently asked questions[R/OL].(2018)[2019-12-22].https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspectionreferences/inspections-database-frequently-asked-questions#classification.

[5]ICH E6(R2)Good clinical practice[R/OL].[2019-10-28].https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice.

[6]Lawrence B,Sawyer.The practice of modern internal auditing[M].2nd ed.Altamonte Springs,FL:Institute of International Auditors,1983:3.