摘要药物临床试验质量管理规范（Good Clinical Practice for Drugs，GCP）是关于药物临床试验全过程（包括方案设计、组织、实施、监察、稽查、记录、分析总结和报告）管理的标准。实施GCP的目的在于维护受试者权益、保障临床研究的有效性以及确保试验数据质量能够达到药管权威机构的标准要求。
2U.S. Food and Drug Administration. 21CFR: CFR-Code of feder- al regulations title 21 [ EB/OL]. [2011 -05 - 18 ]. http://www. accessdata, fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch, cfm.
3European Medicines Agency. ICH-E6: ICH topic E6(R1) guide- line for good clinical practice [ EB/OL ]. [ 2011 - 05 - 18 ]. ht- tp ://www. ema. europa, eu/docs/en_GB/document_library/Sci- entific_guideline/2009/O9/WCSO0002874, pdf.
4LEVINSON DR. The Food and drug administration's oversight of clinical trials[ EB/OL]. (2010 - 05 - 18 ). http ://oig. hhs. gov/ oei/reports/oei-01-06-00160, pdf.
5Medicines and Healthcare Products Regulatory Agency. Good Clin-ical Practice ; The inspectionprocess [ EB/OL ]. [ 2014 - 05 -20] . http://www. mhra. gov. uk/Howweregulate/Medicines/In-spectionandstandards/GoodClinicalPractice/Theinspectionprocess/index, htm.
6MORGAN-LINNELL SK,STEWART DJ,KURZROCK R. US Foodand Drug Administration inspections of clinical investigators : o-verview of results from 1977 to 2009 [ J]. Clin Cancer Res ,2010,20(13) : 1 -7.
