医药导报2026，Vol.45Issue(5)：803-808,6.DOI:10.3870/j.issn.1004-0781.2026.05.010
研究者发起的临床研究合同全生命周期的风险管控
Risk Management Across the Entire Life Cycle of Investigator-Initiated Trial Contracts
摘要
Abstract
Investigator-initiated trials(IIT)conducted by healthcare institutions exhibit diverse funding sources and rapid quantitative growth.IIT contracts are legally binding agreements that define rights and obligations in clinical research colla-borations between hospitals and external parties;their risk management has become a critical component of hospital clinical re-search administration.However,fragmented management,insufficient standardization,and a lack of standardization processes in IIT contracts have elevated contract risk prevention as a significant challenge in hospital governance.From the perspective of risk ma-nagement and the internal control requirements of hospital functional departments,this study analyzes the current state of funded IIT contract management.It reconstructs an analytical framework based on contract life-cycle phases,identifies and mitigates risks across the entire contract life cycle,and proposes a comprehensive risk control system encompassing"preventive measures,real-time monitoring,and post-event feedback"to promote the refinement and intelligence transformation of clinical research in health-care institutions.关键词
研究者发起的临床研究/合同管理/全生命周期/风险管控Key words
Investigator-initiated trials/Contract management/Entire life cycle/Risk control分类
医药卫生引用本文复制引用
熊若曲,谢丽娟,郝军,汤莉,张婧,涂佳楠,张紫菲,程晓华..研究者发起的临床研究合同全生命周期的风险管控[J].医药导报,2026,45(5):803-808,6.基金项目
江西省卫生健康委科技计划项目(202310303) （202310303）
南昌大学第一附属医院管理创新研究(YGZX2024012D). （YGZX2024012D）
