| 临床试验用药品管理的临床协调员问卷调查及分析 |
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| 引用本文： | 刘桂海,王晓霞,王洪,刘丹,吴珮涵,文艳丽.临床试验用药品管理的临床协调员问卷调查及分析[J].中国药物与临床,2022(1):17-20. |
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| 作者姓名： | 刘桂海 王晓霞 王洪 刘丹 吴珮涵 文艳丽 |
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| 作者单位： | 1.山西医科大学第二临床医学院;2.山西医科大学第二医院药物/医疗器械临床试验机构;3.上海津石医药科技有限公司 |
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| 基金项目： | 山西省软科学研究项目(2017041038-4)。 |
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| 摘 要： | 目的 了解药物临床试验过程中试验用药品管理方面存在的问题,为临床试验机构相关部门在临床试验用药品管理方面提供参考.方法 以临床协调员为调查对象,采用网络调查问卷方式,围绕试验用药品管理中容易出现的问题进行调查.结果 ①药检报告中批号与实际接收药品批号不一致占2.70％(16/592),14.36％(85/592)不是药...
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| 关 键 词： | 药物临床试验质量管理规范 调查和问卷 临床协调员 |
Questionnaire survey and analysis on drug management for clinical trials among clinical research coordinators |
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| Liu Guihai,Wang Xiaoxia,Wang Hong,Liu Dan,Wu Peihan,Wen Yanli.Questionnaire survey and analysis on drug management for clinical trials among clinical research coordinators[J].Chinese Remedies & Clinics,2022(1):17-20. |
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| Authors: | Liu Guihai Wang Xiaoxia Wang Hong Liu Dan Wu Peihan Wen Yanli |
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| Institution: | (The Second Clinical School,Shanxi Medical University,Taiyuan 030001,China;Departments ofDrugs and Medical Devices Clinical Trail Institution,the Second Hospital of Shanxi Medical University,Taiyuan 030001,China;Shanghai Medkey Medical Technology Development Company,Shanghai 200001,China) |
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| Abstract: | Objective To investigate potential problems in the management of study drugs during conduction of drug clinical trials,and to offer evidence on management of drugs used in clinical trials for relevant authorities of clinical trial research organizations.Methods Included in this survey were clinical research coordinators(CRCs)who completed a network-based questionnaire in relation to the problems likely to appear in the management of study drugs.Results①2.70%(16/592)of the batch numbers in drug inspection report were inconsistent with those actually received.14.36%(85/592)of the drugs in the inspection report were not ethically filed.②0.51%(3/592)of the temperature equipments were calibrationoutdated,12.33%(73/592)were not with an alarm device,and 30.41%(180/592)were problematic with missing temperature records of the study drugs.③5.07%(30/592)of the study drugs were distributed incorrectly.Conclusion The problems in reception,storage,distribution,use and recording of study drugs should not be downplayed.Relevant authorities of clinical trial research organizations should improve their system and install specific software and hardware facilities for drug management,enhance quality control and supervision,and reinforce training for drug management workers,rectify the managerial mode and process of clinical trial drugs,ensuring that clinical trial process is standardized,the results are scientifically reliable,and the rights and health of subjects are guaranteed. |
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| Keywords: | Good clinical practice Survey and questionnaires Clinical research coordinator |
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