Article(id=1291339041929163132, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.022, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1726329600000, receivedDateStr=2024-09-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808819515, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808819515, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808819515, creator=13041195026, updateTime=1785808819515, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=260, endPage=263, ext={EN=ArticleExt(id=1291339042113712509, articleId=1291339041929163132, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Management of drugs in clinical trials, columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

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.

, authors=Qiang ZHANG¹, Hong-ling XI¹, Ai-lian SHAN², authorsList=Qiang ZHANG, Hong-ling XI, Ai-lian SHAN, authorCompany=null, correspAuthors=Ai-lian SHAN, 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=1291339042696720766, articleId=1291339041929163132, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=临床试验用药品的管理探讨, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

规范化试验用药品的管理是保护受试者安全和确保试验结果科学可靠的重要手段之一。试验用药品管理贯穿于临床试验全过程，有医院集中管理、有科室进行管理，参与人员有医师、护士、药师等。本研究调查了15家医院的试验用药品管理情况，结合国内相关法规及部分指南共识，对试验用药品的管理过程进行归纳。应优先用中心药房配备专职药学人员管理模式，若为科室管理模式，由研究医师/护士或具备必要的资质和能力的药学人员担任药品管理员，试验药品接收与验收入库、退回申办方由机构药品管理员来完成。临床试验用药品的发放可以授权专业背景为药学且取得专业技术资格证书或执业药师证书的人员，若为非药师人员发放试验用药品，应用同等效力的其他文件而不是根据处方发放试验药品。

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张强（1972-），男，副主任药师，主要从事临床药学的相关研究和工作

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张强（1972-），男，副主任药师，主要从事临床药学的相关研究和工作

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