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[1]徐贝贝李雪姣闫亚军杨雨晨裴春丽.基于瀑布模型的研究者发起临床研究项目全流程质量管理模式探索[J].中国卫生质量管理,2026,33(7):51-54.[doi:10.13912/j.cnki.chqm.2026.33.7.10]
　XU Beibei,LI Xuejiao,YAN Yajun.Exploration of Full-Process Quality Management Model for Investigator-Initiated Trial Based on Waterfall Model[J].Chinese Health Quality Management,2026,33(7):51-54.[doi:10.13912/j.cnki.chqm.2026.33.7.10]

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基于瀑布模型的研究者发起临床研究项目全流程质量管理模式探索

《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R] 卷: 33 期数: 2026年7期页码: 51-54 栏目: 医疗质量出版日期: 2026-07-15

Title:: Exploration of Full-Process Quality Management Model for Investigator-Initiated Trial Based on Waterfall Model

作者:: 徐贝贝李雪姣闫亚军杨雨晨裴春丽; 首都医科大学附属北京天坛医院

Author(s):: XU Beibei; LI Xuejiao; YAN Yajun; Beijing Tiantan Hospital, Capital Medical University

关键词:: 研究者发起的临床研究项目; 瀑布模型; 全流程管理; 质量管理

Keywords:: Investigator-Initiated Trial; Waterfall Model; Full-Process Management; Quality Management

分类号:: R197.323

DOI:: 10.13912/j.cnki.chqm.2026.33.7.10

文献标志码:: B

摘要:: 针对研究者发起的临床研究（IIT）管理流程不清晰、环节衔接不畅、缺乏有效反馈等问题，首都医科大学附属北京天坛医院借鉴软件工程瀑布模型理念，构建了“六环节递进、三阶段归集、全流程反馈”的IIT管理模式。将IIT管理划分为项目分析、立项论证、资源匹配、运行实施、验收评估、成果转化6个递进环节，归集为设计论证、组织实施、成果产出3个阶段，建立了环节内反馈、阶段间反馈、全流程反馈三级反馈机制，并配套制订了相应制度。应用该模式后，在立项数量增加的情况下，立项中位时间缩短，项目实施首年关键问题调整率下降，首次伦理审查通过率提高，D级项目占比降低，实现了IIT规范化管理和质量提升。

Abstract:: To address issues such as unclear management processes, poor connectivity between steps, and lack of effective feedback in investigator-initiated trial (IIT) management, Beijing Tiantan Hospital, Capital Medical University, drawing on the concept of the software engineering waterfall model, constructed an IIT management model featuring "six progressive steps, three aggregation phases, and full-process feedback". IIT management was divided into six progressive steps: project analysis, project establishment argumentation, resource matching, operation and implementation, acceptance evaluation, and outcome translation, which were aggregated into three phases: design and argumentation, organization and implementation, and outcome production. A three-level feedback mechanism was established, comprising intra-step feedback, inter-phase feedback, and full-process feedback, along with corresponding institutional policies. After the implementation of this management model, despite an increase in the number of project approvals, the median project establishment time was shortened, the adjustment rate of key issues in the project plan during the first year of implementation decreased, the first-pass ethical review approval rate increased, and the proportion of grade D projects decreased, achieving standardized management and quality improvement of IIT.

参考文献/References:

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更新日期/Last Update: 2026-07-15