临床研究协调员的教育培训与临床试验现场管理
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摘要
自全国开展药物临床试验数据自查核查后,针对临床试验现场管理及质量提出了更高的要求。本文梳理了国内临床研究协调员(CRC)教育培训现状,介绍国内外主要CRC认证体系,探索解决CRC教育培训与临床试验现场管理需求间矛盾的策略。
引文
[1]卜擎燕,熊宁宁,邹建东,等.临床试验的重要角色:临床研究协调员[J].中国临床药理学与治疗学,2006,11(10):1190-1193.
[2]国家食品药品监督管理总局.国家食品药品监督管理总局关于开展药物临床试验数据自查核查工作的公告[EB/OL].(2015-07-22)[2017-11-04].http://www.sda.gov.cn/WS01/CL0087/124800.html.
[3]中国CRC之家.为了受试者和医疗信息安全,CRC将开始全国统一编码[EB/OL].(2017-08-24)[2017-11-04].http://mp.weixin.qq.com/s/Vd Wq_ALErp X_FMbbx05Phw.
[4]熊蔚霞,江卫玲,张宏声,等.中国中小型药物临床试验合同研究组织企业面临的挑战和机遇[J].世界临床药物,2015,36(10):715-718.
[5]王欣,汪芳,李燕,等.中国临床研究协调员规范化培训的现状[J].中国临床药理学杂志,2016,32(12):1144-1146.
[6]Society of clinical research associates.CCRP?examination outline[EB/OL].[2017-11-04].http://www.socra.org/assets/Certification/Detailed-Exam-Content-Outline-150317.pdf.
[7]中野重行.CRCの教育:その育成を推進してきた医師の立場から[J].臨床薬理,2011,42(4):269-270.
[8]日本SMO協会.日本SMO協会SMA教育?公認要綱細則[EB/OL].http://www.jasmo.org/ja/expart/pdf/guideline_de tail_sma20170523.pdf.
[9]中关村玖泰药物临床试验技术创新联盟,中国药物临床试验机构联盟.临床研究协调员(CRC)行业指南(试行)[J].药物评价研究,2015,38(3):233-237.
[10]Haeusler JMC.Certification in good clinical practice and clinical trial quality:A retrospective analysis of protocol adherence in four multicenter trials in the USA[J].Clin Res Regul Aff,2009,26(1-2):20-23.
[11]Speicher LA,Fromell G,Avery S,et al.The critical need for academic health centers to assess the training,support,and career development requirements of clinical research coordinators:recommendations from the clinical and translational science award research coordinator taskforce[J].Clin Transl Sci,2012,5(6):470-475.
[12]Rico-Villademoros F,Hernando T,Sanz JL,et al.The role of the clinical research coordinator-data manager-in oncology clinical trials[J].BMC Med Res Methodol,2004,4(1):6-6.
[2]国家食品药品监督管理总局.国家食品药品监督管理总局关于开展药物临床试验数据自查核查工作的公告[EB/OL].(2015-07-22)[2017-11-04].http://www.sda.gov.cn/WS01/CL0087/124800.html.
[3]中国CRC之家.为了受试者和医疗信息安全,CRC将开始全国统一编码[EB/OL].(2017-08-24)[2017-11-04].http://mp.weixin.qq.com/s/Vd Wq_ALErp X_FMbbx05Phw.
[4]熊蔚霞,江卫玲,张宏声,等.中国中小型药物临床试验合同研究组织企业面临的挑战和机遇[J].世界临床药物,2015,36(10):715-718.
[5]王欣,汪芳,李燕,等.中国临床研究协调员规范化培训的现状[J].中国临床药理学杂志,2016,32(12):1144-1146.
[6]Society of clinical research associates.CCRP?examination outline[EB/OL].[2017-11-04].http://www.socra.org/assets/Certification/Detailed-Exam-Content-Outline-150317.pdf.
[7]中野重行.CRCの教育:その育成を推進してきた医師の立場から[J].臨床薬理,2011,42(4):269-270.
[8]日本SMO協会.日本SMO協会SMA教育?公認要綱細則[EB/OL].http://www.jasmo.org/ja/expart/pdf/guideline_de tail_sma20170523.pdf.
[9]中关村玖泰药物临床试验技术创新联盟,中国药物临床试验机构联盟.临床研究协调员(CRC)行业指南(试行)[J].药物评价研究,2015,38(3):233-237.
[10]Haeusler JMC.Certification in good clinical practice and clinical trial quality:A retrospective analysis of protocol adherence in four multicenter trials in the USA[J].Clin Res Regul Aff,2009,26(1-2):20-23.
[11]Speicher LA,Fromell G,Avery S,et al.The critical need for academic health centers to assess the training,support,and career development requirements of clinical research coordinators:recommendations from the clinical and translational science award research coordinator taskforce[J].Clin Transl Sci,2012,5(6):470-475.
[12]Rico-Villademoros F,Hernando T,Sanz JL,et al.The role of the clinical research coordinator-data manager-in oncology clinical trials[J].BMC Med Res Methodol,2004,4(1):6-6.