新形势下研究者发起的临床研究立项管理要点  

Key Points of Investigator Initiated Trial Approval Management Under the New Situation

作　　者：程晓华[1] 舒展 徐文炜[2] 温金华[1] 胡锦芳[1] CHENG Xiaohua;SHU Zhan;XU Wenwei;WEN Jinhua;HU Jinfang(Drug Clinical Trial Center,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Institute of Clinical Pharmacology of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院临床试验研究中心,南昌330006 [2]南昌大学临床药理研究所,南昌330006

出　　处：《医药导报》2022年第2期266-270,共5页Herald of Medicine

基　　金：“十三五”国家科技重大专项(2020ZX09201027)。

摘　　要：随着研究者发起的临床研究的蓬勃发展以及国家对临床研究规范管理的要求不断提升,医疗机构开展临床研究的积极性也日益高涨。该文依据临床研究相关法规,结合相关文献和既往临床研究的管理经验,对研究者发起的临床研究立项管理过程中存在的常见问题表现形式、责任主体、管理模式进行探讨,并对归口管理部门和管理团队的确定,研究项目形式审查、学术和伦理审查、合同审查等关键环节中可能的风险要点进行分析和阐述。通过主动建立风险模式下动态的立项管理体系,强化管理部门的能力建设和管理职能,规范的立项审查流程以及信息化平台的支撑是开展立项审查和管理的重要保障,有助于研究者发起的临床研究的可持续发展。With the vigorous development of investigator initiated trials and the continuous improvement of the national requirements for the management of clinical research,the enthusiasm of medical institutions to carry out clinical research is also growing.According to clinical research relevant laws and regulations,combined with access to relevant documents and previous clinical studies of management experience,common problems existing in the project management process,management mode,and the main responsibility were explored.And the management department and team,formal examination,academic and ethical review,contract review and other key links in the possible risk points of the clinical research are analyzed and elaborated.Through the establishment of a dynamic project approval management system under the risk mode,the strengthening of the capacity building and management functions of the management department,and the standardized project approval review process and the support of the information platform are the important guarantees for the implementation of project approval review and management,which will contribute to the sustainable development of investigator initiated trials.

关 键 词：研究者发起的临床研究 立项审查 质量管理 风险管理 

分 类 号：R951[医药卫生—药学]