【摘要】：目的:促進藥物臨床試驗管理水平,保證臨床試驗質量。方法:參照《藥物臨床試驗質量管理規(guī)范》(GCP)和《藥物臨床試驗機構資格認定復核檢查標準》對試驗藥品的管理要求,檢查我院臨床試驗藥品在貯存保管硬件設施、管理人員資質及接收、貯存、發(fā)放、回收資料記錄等管理中存在的問題,并提出改進措施及相關建議。結果與結論:我院臨床試驗藥品在硬件設施和人員資質方面基本符合要求,但在接收、貯存、發(fā)放、回收等記錄管理中存在缺陷,為此制訂了改善藥品管理流程、完善記錄等措施,并提出建立電子化藥品管理系統(tǒng)、藥師積極參與藥物臨床試驗的全過程干預、臨床試驗機構辦設立專職藥師管理試驗用藥品的建議等。
[Abstract]:Objective: to promote the management of clinical trials and ensure the quality of clinical trials. Methods: according to the management requirements of (GCP) and qualification check Standard for Drug Clinical trial, we examined the storage and storage hardware facilities of clinical trial drugs in our hospital. Management personnel qualification and management of receiving, storage, distribution, recovery of data records and other management problems, and put forward improvement measures and related recommendations. Results & conclusion: the clinical trial drugs in our hospital basically meet the requirements in terms of hardware facilities and personnel qualifications, but there are some defects in the record management of receiving, storage, distribution and recovery. Some measures such as perfecting records, establishing electronic drug management system, actively participating in the whole process intervention of drug clinical trials, and setting up full-time pharmacists to manage drugs used in clinical trials were put forward.
【作者單位】： 四川省醫(yī)學科學院·四川省人民醫(yī)院藥學部;
【分類號】：R95

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