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 LI1, Huiqin LU2, Meichen YU1, Bowen CAILIN1, Qiutian YU2, Guohua CHENG1, *, 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1, *, authorsList=李嘉浩, 卢慧勤, 余美辰, 蔡林柏闻, 余秋钿, 程国华, authorCompany=null, correspAuthors=程国华, authorNote=

李嘉浩,在读硕士,研究方向:药物临床试验

, correspAuthorsNote=

*

程国华,教授,博士生导师,研究方向:药物临床试验,E-mail:
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李嘉浩,在读硕士,研究方向:药物临床试验

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李嘉浩,在读硕士,研究方向:药物临床试验

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药物临床试验中生物样本管理的问题分析与风险防控
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李嘉浩 1 , 卢慧勤 2 , 余美辰 1 , 蔡林柏闻 1 , 余秋钿 2 , 程国华 1, *
今日药学 | 临床药学 2026,36(1): 53-58
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今日药学 |临床药学 2026 , 36 (1) : 53 -58
药物临床试验中生物样本管理的问题分析与风险防控
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李嘉浩1, 卢慧勤2, 余美辰1, 蔡林柏闻1, 余秋钿2, 程国华1, *
作者信息
  • 1.暨南大学药学院,广东 广州 510000
  • 2.广东省第二人民医院,广东 广州 510317
通讯作者:

*

程国华,教授,博士生导师,研究方向:药物临床试验,E-mail:
作者简介:

李嘉浩,在读硕士,研究方向:药物临床试验

Analysis and Risk Management of Biological Sample Management in Drug Clinical Trials
Jiahao LI1, Huiqin LU2, Meichen YU1, Bowen CAILIN1, Qiutian YU2, Guohua CHENG1, *
Affiliations
  • 1.School of Pharmacy, Jinan University, Guangzhou, Guangdong 510000, China
  • 2.Guangdong Second Provincial General Hospital, Guangzhou, Guangdong 510317, China
出版时间: 2026-01-25 doi: 10.12048/j.issn.1674-229X.2026.01.010
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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。

临床试验  /  生物样本  /  样本管理  /  生物样本管理  /  风险防范措施
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.

clinical trials  /  biological samples  /  biological sample management  /  risk prevention measures
李嘉浩, 卢慧勤, 余美辰, 蔡林柏闻, 余秋钿, 程国华. 药物临床试验中生物样本管理的问题分析与风险防控. 今日药学, 2026 , 36 (1) : 53 -58 . DOI: 10.12048/j.issn.1674-229X.2026.01.010
Jiahao LI, Huiqin LU, Meichen YU, Bowen CAILIN, Qiutian YU, Guohua CHENG. Analysis and Risk Management of Biological Sample Management in Drug Clinical Trials[J]. Pharmacy Today, 2026 , 36 (1) : 53 -58 . DOI: 10.12048/j.issn.1674-229X.2026.01.010
  • 国家药品监督管理局药品审评检查大湾区分中心监管科学研究课题(GBA-JGKX-2403)
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doi: 10.12048/j.issn.1674-229X.2026.01.010
  • 接收时间:2025-03-12
  • 首发时间:2026-09-23
  • 出版时间:2026-01-25
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  • 收稿日期:2025-03-12
基金
国家药品监督管理局药品审评检查大湾区分中心监管科学研究课题(GBA-JGKX-2403)
作者信息
    1.暨南大学药学院,广东 广州 510000
    2.广东省第二人民医院,广东 广州 510317

通讯作者:

*

程国华,教授,博士生导师,研究方向:药物临床试验,E-mail:
参考文献
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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