浅谈临床试验中药物管理要点及注意事项
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篇名: 浅谈临床试验中药物管理要点及注意事项
TITLE:
摘要: 目的:为完善临床试验药物管理相关标准操作规程及临床试验药物管理提供参考。方法:以《药物临床试验质量管理规范》(GCP)、《药物临床试验数据现场核查要点》《药物临床试验机构资格认定检查细则》为参照,结合我院自2016年7月起进行的质控项目,对临床试验过程药物管理中出现的不规范操作及关键流程的注意事项进行总结,讨论改进措施。结果与结论:试验过程中药物管理不规范是不规范操作的高发环节。其中,药物的接受、发放与使用是试验过程药品管理不规范操作发生率最高的三个环节,因此,各单位在制订相关管理制度时可根据自身情况加以重点关注,例如在接收临床试验药物时,要注意检查药物外包装完好程度;冷链运输的药品还应检查温度记录,遇有超温作出拒收处理;运货单复印后与原件共存档避免热敏纸褪色;对照药品及安慰剂的相关特征是否符合规定等。各机构可从试验过程药品管理的关键环节、立项时、项目启动时、质控与监查四个方面进行规范,制订并不断完善相关药物管理制度、标准操作规程(SOP),例如在项目启动时,需注意药物管理员参加启动会培训并签字、相关表格的设计是否完整、规范、可操作。临床试验机构有必要重视试验药物管理的标准化、精密化,注重临床试验过程中的关键环节。
ABSTRACT: OBJECTIVE: To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS: According to Good Clinical Practice (GCP), Data On-site Verification Points of Drugs Clinical Trial, Qualification Examination Rules of Drug Clinical Trial Institution, based on the quality control project carried out in our hospital since July 2016, the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized, and the improvement measures were discussed. RESULTS & CONCLUSIONS: Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them, the acceptance, distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore, when formulating the relevant management system, each institution should pay attention to it according to its own situation; such as, when accepting drugs in clinical trials, attention should be paid to checking the intact degree of drug packaging; drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature; the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper; whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process, the time of project establishment, project start-up, quality control and supervision, formulate and constantly improve the relevant drug management system and standard operating procedures (SOP). For example, when starting a project, attention should be paid to the participation of drug administrators in the training and signature of start-up meeting, whether the design of the form is complete, standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.
期刊: 2019年第30卷第21期
作者: 谢江川,郭薇,谢林利,李明红,潘辛梅,曹丽亚,陈勇川
AUTHORS: XIE Jiangchuan,GUO Wei,XIE Linli,LI Minghong,PAN Xinmei,CAO Liya,CHEN Yongchuan
关键字: 药物临床试验;试验药物;管理;药物临床试验质量管理规范
KEYWORDS: Drug clinical trial; Trial drugs; Management; Good Clinical Practice
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