| 陈震,王方敏,吴正宇,于冰,陈江鹏,高丽萍,杨建红.药物临床研究阶段申办者和生产场地变更研究六:临床研究阶段申办者和生产场地跨境变更的风险分析[J].中国药事,2024,38(5):538-548 |
| 药物临床研究阶段申办者和生产场地变更研究六:临床研究阶段申办者和生产场地跨境变更的风险分析 |
| Research Ⅵ on the Changes of Sponsors and Production Sites during theClinical Research Phase of Drugs: Risk Analysis of Cross-border Changes ofSponsors or Production Sites in the Clinical Research Phase |
| 投稿时间：2023-12-11 |
| DOI：10.16153/j.1002-7777.2024.05.006 |
| 中文关键词: 临床研究阶段 申办者 生产场地 跨境变更 风险分析 |
| 英文关键词: clinical research phase sponsor production site cross-border change risk analysis |
| 基金项目:中国药品监督管理研究会委托亦弘商学院开展的“我国临床研究阶段申办者和生产场地变更研究”课题（编号 2021-Y-Y-22） |
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| 中文摘要: |
| 目的：通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析，为申办者和生产场地的跨境变更管理提供参考。方法：基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果，比较分析不同组合情形之间发生变更时变更前后的“风险指数水平”变化。结果与结论：基于初始风险评价结果，有两种变更情形的风险指数水平在变更后较变更前降低；基于风险再评价结果，有四种变更情形的风险指数水平在变更后较变更前降低。 |
| 英文摘要: |
| Objective: To evaluate and analyze the risk changes of cross-border changes in sponsors orproduction sites, and provide reference for the management of cross-border changes in sponsors and productionsites. Methods: Based on the initial risk assessment results of different combination modes of the sponsors and production sites, and the risk re-evaluation results after implementing risk control measures, a comparativeanalysis was conducted on the changes in the "risk index level" before and after the changes occur betweendiff erent combination modes. Results and Conclusion: Based on the results of the initial risk evaluation, the riskindex levels of two change scenarios were lower after the change than before the change, and based on the resultsof the risk re-evaluation, the risk index levels of four change scenarios were lower after the change than before thechange. |
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