Article(id=1291707136329933477, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.22.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1751472000000, receivedDateStr=2025-07-03, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896580058, onlineDateStr=2026-08-05, pubDate=1764259200000, pubDateStr=2025-11-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896580058, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896580058, creator=13701087609, updateTime=1785896580058, updator=13701087609, issue=Issue{id=1291707004800750583, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='22', pageStart='3151', pageEnd='3300', issueExtLink='null', onlineDate='null', pubDate='1764259200000', pubDateStr='2025-11-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896548700, creator='13701087609', updateTime=1785896693213, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707610999316815, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707610999316816, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3296, endPage=3300, ext={EN=ArticleExt(id=1291707136606757542, articleId=1291707136329933477, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of biological sample management issues and recommendations for improvement in Phase I clinical trial laboratories, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Xue-lan HE, Yi ZHAO, Yan LEI, Wei-tong LIN, Xu YANG, Kai-peng HUANG, authorsList=Xue-lan HE, Yi ZHAO, Yan LEI, Wei-tong LIN, Xu YANG, Kai-peng HUANG, authorCompany=null, correspAuthors=Kai-peng HUANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291707137164599975, articleId=1291707136329933477, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=Ⅰ期临床试验研究室生物样本管理问题分析及改进建议, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=
目的 分析药物临床试验样本管理中的不规范问题，探讨其对受试者权益及数据科学性与完整性的影响，并提出针对性改进建议。
方法 采用回顾性方法，选取2018年4月至2024年12月我院Ⅰ期临床试验研究室开展样本处理的69项临床试验项目（包括生物等效性试验及创新药Ⅰ~Ⅳ期试验），通过专业质控员、机构办公室质控员及临床研究监查员（CRA）的监查记录，汇总生物样本管理问题。分析问题分布特征，并基于方案偏离（PD）评估体系对不规范问题进行分级判断及根本原因分析。
结果 共发现生物样本管理问题68例，主要集中于样本采集（27.94%）、处理（19.12%）及保存（36.76%）环节。PD评估显示，操作流程疏漏（如未按标准操作规程执行）、人员培训不足及记录不规范为问题的主要根源。
结论 临床试验样本管理需强化关键环节的标准化操作、完善人员培训、质控体系及引入信息化智能系统等多维度的标准化管理措施，为高质量临床研究提供可靠的样本支撑。
, authors=何雪兰, 赵翼, 雷燕, 林伟彤, 杨旭, 黄凯鹏, authorsList=何雪兰, 赵翼, 雷燕, 林伟彤, 杨旭, 黄凯鹏, authorCompany=null, correspAuthors=黄凯鹏, authorNote=
何雪兰（1989-），女，主管药师，主要从事药物临床试验药品管理及生物样本管理工作
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