摘要
我国的临床研究协调员(clinical research coordinator,CRC)行业正处于快速发展阶段,国内部分药物临床试验机构已有CRC团队,由本院退休的医技和护理人员担任;同时,申办者及合同研究组织(contract research organization,CRO)机构也在培训自己的CRC团队;还有一部分药物临床试验机构采取与现场管理组织(site management organization,SMO)公司合作来培养管理CRC。苏州大学附属第二医院药物临床试验机构采取与SMO公司合作,共同培养、共同管理CRC,并在实际工作中取得了一定成效,同时也积累了实践经验。现就本院临床试验机构在药物临床试验过程中,CRC的运行机制和具体工作职责进行简要介绍,为各药物临床试验机构的建设和管理提供参考。
Clinical research coordinator（CRC）industry is in the stage of rapid development in China.Some of the domestic institutes of clinical drug trial（ICDT）have already had their own CRC teams,which consist of medical and nursing staff personnel who retired from the hospital.At the same time,sponsers and contract research organization（CRO）institutions are also training their CRC teams.The Institute of National Clinical Drug Trial in the Second Hospital Affiliated to Suzhou University is one of ICDTs,which cooperates with the site management organization（SMO）companies to co-cultivate and co-manage CRCs.Successes have been made and experience has been accumulated through actual practice.Here is a brief introduction of the operating mechanism and the specific job responsibilities of CRC with an aim to provide reference for the construction and management of the clinical trial organizations.
出处
《药学服务与研究》
CAS
2016年第2期155-157,共3页
Pharmaceutical Care and Research
关键词
药物临床试验
临床研究协调员
管理与培养
clinical drug trials
clinical research coordinator
management and training
作者简介
朱艺芳（女），主管药师．E-mail：applegirlOl01@163．com
