摘要
目的设计一套研究者发起的临床研究全流程档案核心文件,以规范临床研究管理工作。方法收集当前研究者发起的临床研究监督检查要点及近年来检查过程中发现的问题,并采用多轮专家咨询的形式,最终确定全流程档案核心目录。结果经过多轮的专家咨询与访谈,对研究者发起的临床研究全流程档案核心目录进行修改,最终确定了包含立项阶段、实施阶段、结题验收阶段的44条核心文件目录。结论医疗卫生机构管理部门应当开展培训,要求研究者按照目录准备项目文档,从而规范研究者发起的临床研究,规范档案管理工作,确保临床研究数据的真实性、完整性和可溯源性。
Objective To design a set of core documents for the full-process archives of investigator-initiated clinical trials,with the aim of standardizing clinical trial management.Methods The key points for the supervision and inspection of current investigator-initiated clinical trials,as well as issues identified during recent inspections,were collected.Multiple rounds of expert consultation were conducted to finalize the core directory for the full-process archives.Results Through multiple rounds of expert consultations and interviews,the core directory for the full-process archives of investigator-initiated clinical trials was revised.Ultimately,a directory comprising 44 core documents was established,covering the project initiation stage,implementation stage,and conclusion and acceptance stage.Conclusion Management departments of healthcare institutions should provide training and require investigators to prepare project documentation in accordance with this directory.This will help standardize investigator-initiated clinical trials,enhance archive management,and ensure the authenticity,integrity,and traceability of clinical trial data.
作者
陶庆梅
于新颖
TAO Qing-mei;YU Xin-ying(Beijing Institute for Cancer Research/Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education))
出处
《医院管理论坛》
2026年第3期88-91,33,共5页
Hospital Management Forum
基金
北京市研究者发起的临床研究规范管理质量提高项目,编号:京研2024-2。
关键词
研究者发起的临床研究
档案管理
全流程管理
Investigator-initiated clinical trials(IIT)
Archive management
Full-process management
