研究者发起的临床研究合同全生命周期的风险管控OA

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.