Management of drugs in clinical trials
10.13699/j.cnki.1001-6821.2025.02.022
- VernacularTitle:临床试验用药品的管理探讨
- Author:
Qiang ZHANG
1
;
Hong-ling XI
;
Ai-lian SHAN
Author Information
1. 联勤保障部队第九四○医院国家药物临床试验机构,甘肃兰州 730050
- Publication Type:Journal Article
- Keywords:
drug clinical trial;
clinical trial drug;
management mode;
managerial personnel
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):260-263
- CountryChina
- Language:Chinese
-
Abstract:
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.
