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Analysis and Risk Management of Biological Sample Management in Drug Clinical Trials
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Jiahao LI1, Huiqin LU2, Meichen YU1, Bowen CAILIN1, Qiutian YU2, Guohua CHENG1, *
Pharmacy Today | 2026, 36(1) : 53 - 58
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Pharmacy Today | 2026, 36(1): 53-58
Analysis and Risk Management of Biological Sample Management in Drug Clinical Trials
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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
Published: 2026-01-25 doi: 10.12048/j.issn.1674-229X.2026.01.010
Outline
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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
Appendix
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Year 2026 volume 36 Issue 1
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Article Info
doi: 10.12048/j.issn.1674-229X.2026.01.010
  • Receive Date：2025-03-12
  • Online Date：2026-09-23
  • Published：2026-01-25
Article Data
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History
  • Received：2025-03-12
Funding
Affiliations
    1.School of Pharmacy, Jinan University, Guangzhou, Guangdong 510000, China
    2.Guangdong Second Provincial General Hospital, Guangzhou, Guangdong 510317, China
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https://castjournals.cast.org.cn/joweb/jryx/EN/10.12048/j.issn.1674-229X.2026.01.010
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Citations
表12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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