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Management of drugs in clinical trials
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Qiang ZHANG1, Hong-ling XI1, Ai-lian SHAN2
Chinese Journal of Clinical Pharmacology | 2025, 41(2) : 260 - 263
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Chinese Journal of Clinical Pharmacology | 2025, 41(2): 260-263
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Management of drugs in clinical trials
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Qiang ZHANG1, Hong-ling XI1, Ai-lian SHAN2
Affiliations
  • 1.State Medical Institution, The 940th Hospital of Joint Logistics Support Force, Lanzhou 730050, Gansu Province, China
  • 2.Institute of Clinical Pharmacology, Peaking University First Hospital, Beijing 100191, China
Published: 2025-01-28 doi: 10.13699/j.cnki.1001-6821.2025.02.022
Outline
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Standardizing the management of drugs used in clinical trials is one of the important means to protect the safety of trial participants and ensure that the trial results are scientifically reliable. The management of trial drugs runs throughout the entire clinical trial process, with some hospitals centralizing the management and others managing it within departments. Participants in the process include doctors, nurses, and pharmacists, among others. Investigate the management of investigational drugs in 15 hospitals and combine domestic relevant regulations and guidelines to standardize the management process of investigational drugs. A central pharmacy staffed by dedicated pharmacy personnel should be preferred, and if a departmental management model is used, a research physician/nurse or a pharmacy personnel with the necessary qualifications and competencies should be appointed as the drug manager. The reception and inventory of clinical trial drugs, as well as the return of drugs to the sponsor, should be completed by the institutional drug manager. The distribution of clinical trial drugs can be authorized to individuals with a professional background in pharmacy who have obtained professional qualification certificates or licensed pharmacist certificates. If non-pharmacist personnel distribute clinical trial drugs, other equivalent documents should be used instead of dispensing drugs based on prescriptions.

drug clinical trial  /  clinical trial drug  /  management mode  /  managerial personnel
Qiang ZHANG, Hong-ling XI, Ai-lian SHAN. Management of drugs in clinical trials[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (2) : 260 -263 . DOI: 10.13699/j.cnki.1001-6821.2025.02.022
Year 2025 volume 41 Issue 2
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doi: 10.13699/j.cnki.1001-6821.2025.02.022
  • Receive Date:2024-09-15
  • Online Date:2026-08-04
  • Published:2025-01-28
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  • Received:2024-09-15
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Affiliations
    1.State Medical Institution, The 940th Hospital of Joint Logistics Support Force, Lanzhou 730050, Gansu Province, China
    2.Institute of Clinical Pharmacology, Peaking University First Hospital, Beijing 100191, China
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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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