中国临床药理学杂志2025，Vol.41Issue(22)：3296-3300,5.DOI:10.13699/j.cnki.1001-6821.2025.22.022
Ⅰ期临床试验研究室生物样本管理问题分析及改进建议
Analysis of biological sample management issues and recommendations for improvement in Phase Ⅰ clinical trial laboratories
何雪兰 1赵翼 1雷燕 1林伟彤 1杨旭 1黄凯鹏1
作者信息
- 1. 广州医科大学 附属市八医院,广东 广州,510060
- 折叠
摘要
Abstract
Objective To examine issues in sample management within drug clinical trials,their implications on subject rights,data integrity,and propose targeted enhancements.Methods A retrospective analysis was conducted on 69 clinical trial projects,encompassing bioequivalence and innovative drug phase Ⅰ-Ⅳ trials,processed by the phase Ⅰ clinical trial laboratory at our institution from April 2018 to December 2024.Problems in biological sample management were identified through monitoring records maintained by quality control professionals,institutional quality control personnel,and clinical research monitors.The distribution patterns of issues were analyzed,and non-standard problems were assessed and categorized using the protocol deviation(PD)evaluation system.Results A total of 68 issues were identified in biological sample management,primarily centered around sample collection(27.94％),processing(19.12％),and preservation(36.76％).PD evaluations indicated that deficiencies in operational processes(e.g.,non-compliance with standard operating procedures),insufficient personnel training,and irregular documentation were the primary underlying causes.Conclusion Comprehensive standardized management strategies,including enhancing standardized procedures in critical stages,improving personnel training,quality control frameworks,and implementing intelligent information systems,are essential to ensure the provision of dependable sample support for high-caliber clinical research.关键词
临床试验/样本管理/方案偏离Key words
drug clinical trial/biological sample management/protocol deviations分类
医药卫生引用本文复制引用
何雪兰,赵翼,雷燕,林伟彤,杨旭,黄凯鹏..Ⅰ期临床试验研究室生物样本管理问题分析及改进建议[J].中国临床药理学杂志,2025,41(22):3296-3300,5.
