Article(id=1309634759131759475, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634747681304819, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.01.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1741708800000, receivedDateStr=2025-03-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170858414, onlineDateStr=2026-09-23, pubDate=1769270400000, pubDateStr=2026-01-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170858414, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170858414, creator=13701087609, updateTime=1790170858414, updator=13701087609, issue=Issue{id=1309634747681304819, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='1', pageStart='1', pageEnd='80', issueExtLink='null', onlineDate='null', pubDate='1769270400000', pubDateStr='2026-01-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170855683, creator='13701087609', updateTime=1790219109143, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309837137445482891, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634747681304819, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309837137445482892, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634747681304819, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=53, endPage=58, ext={EN=ArticleExt(id=1309634759286948724, articleId=1309634759131759475, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Analysis and Risk Management of Biological Sample Management in Drug Clinical Trials, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE To enhance the standardization of biological sample management in clinical drug trials and ensure the scientific validity and reliability of trial data by collecting and analyzing issues in the management of biological samples during clinical drug trials and preventive risk management strategies.
METHODS Statistical methods were used to conduct data statistics on quality control records. A total of 522 quality control records from three hospitals in Guangzhou were examined to identify non-standard operations in biological sample management and to explore their causes.
RESULTS Among the 522 quality control records analyzed, 160 issues in the biological sample management process were identified. The main problems occurred in the stages of collection, processing, storage, transportation, and transshipment.
CONCLUSION In response to these issues, seven risk prevention measures have been proposed. By implementing these measures, the standardization, accuracy, and safety of biological sample management can be improved, ensuring the integrity and reliability of clinical trial data.
, authors=Jiahao LI
1, Huiqin LU
2, Meichen YU
1, Bowen CAILIN
1, Qiutian YU
2, Guohua CHENG
1, *, authorsList=Jiahao LI, Huiqin LU, Meichen YU, Bowen CAILIN, Qiutian YU, Guohua CHENG, authorCompany=null, correspAuthors=Guohua CHENG, 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=1309634761216328565, articleId=1309634759131759475, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=药物临床试验中生物样本管理的问题分析与风险防控, columnId=1228268588277105398, journalTitle=今日药学, columnName=临床药学, runingTitle=null, highlight=null, articleAbstract=
目的 通过搜集和分析生物样本在药物临床试验管理过程中的问题,探索预防性风险管理策略,以提升临床试验中生物样本管理的规范性,确保试验数据的科学性和可靠性。
方法 采用统计学方法,对质控记录表进行数据统计,对广州市3家医院的522份质控记录表进行分析,识别生物样本管理中的不规范操作,并探讨其原因。
结果 522份质控记录表中,共发现160个生物样本过程中的问题,其问题主要出现在采集、处理、储存、运输与转运等环节。
结论 针对这些问题,提出了7项风险防范措施。通过实施这些措施,提升生物样本管理的规范性、准确性和安全性,确保临床试验数据的完整性和可靠性。
, authors=李嘉浩
1, 卢慧勤
2, 余美辰
1, 蔡林柏闻
1, 余秋钿
2, 程国华
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