摘要
Abstract
Objective To summarize the major issues identified during inspections of clinical trial sites,conduct an in-depth analysis of associated risk factors,and explore strategies for improving clinical trial quality and regulatory effectiveness.Methods A retrospective analysis was conducted on on-site inspection data from the Provincial Drug Regulatory Authorities from 2024 to 2025.The analysis focused on the statistical evaluation of non-compliance categories,specific manifestations,and annual trends.Results A total of 488 non-compliance items were identified from 2024 to 2025,revealing a notable shift in defect distribution.Issues related to documentation systems surged to 36.93％,while those concerning qualification requirements rose to 29.05％.Key problems identified included:a disconnect between documented systems and actual practices;lack of operational feasibility in standard operating procedures(SOPs);inadequate hardware facilities and insufficient temperature/humidity monitoring;weak regulatory awareness among research personnel;excessive reliance on clinical research coordinators(CRCs)during trial implementation;and some principal investigators(PIs)undertaking excessive concurrent projects,thereby compromising trial quality.Additionally,varying degrees of non-compliance were observed in investigational drug management,documentation archiving,ethics review procedures,and protection of subject privacy.Conclusions Regulatory authorities should strengthen scrutiny of the operational feasibility,controlled management,and implementation consistency of institutional documentation systems.Enhanced dynamic oversight is required regarding PI eligibility,training,and concurrent project workloads.Institutions must upgrade hardware facilities and information management systems,while prioritizing standardized CRC management and supervision.Through closed-loop corrective action tracking,improved risk assessment,and categorized regulatory interventions,this approach can facilitate a systematic shift from formal compliance to substantive compliance in drug clinical trials.关键词
药物临床试验机构/监督检查/药物临床试验质量管理规范/缺陷分析/监管对策Key words
Drug clinical trial institutions/Supervision and inspection/Good clinical practice/Defect analysis/Regulatory countermeasures分类
医药卫生
