返回 
加入收藏
对标分析法优化研究者发起的临床研究用药品管理模式
x
请在关注微信后，向客服人员索取文件
| 篇名： | 对标分析法优化研究者发起的临床研究用药品管理模式 |
| TITLE： | Optimization of drug management model for investigator-initiated trial with benchmarking analysis |
| 摘要： | 目的 优化研究者发起的临床研究（IIT）用药品的管理模式。方法采用对标分析法，依据上海某三级专科医院在IIT用药品管理领域的实际工作经验，深入查阅相关法律法规和学术文献，确立标杆，制定评估标准。从临床研究立项开始，通过对研究药品的接收、储存、分发、使用以及回收等关键环节进行逐一对比分析，梳理当前IIT用药品管理实践存在的不足，并提出优化建议。结果经梳理后发现该院的IIT用药品管理存在药品管理员被授权记录缺失、项目执行前培训不足、IIT用药品接收与验收记录不全等问题。针对存在的问题提出加强对药品管理员的培训、规定具有药师资质的药品管理员才能验收药品等改进措施，完善相关制度，同时制定了17项IIT用药品管理质控检查要点。结论本研究初步搭建了医疗机构的IIT用药品管理体系，有助于完善医疗机构在这一领域的制度框架。 |
| ABSTRACT： | OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial （IIT）. METHODS With benchmarking analysis， based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai， a thorough review was conducted， involving relevant laws， regulations， and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects， a detailed comparative analysis of key processes was carried out， such as the receipt， storage， distribution， use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing， the training before project implementation was insufficient， and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems， improvement measures were put forward， including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs， etc. The related systems were improved， and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established， which helps to improve the institutional X2023076） framework of medical institutions in this field. |
| 期刊： | 2025年第36卷第03期 |
| 作者： | 席宇飞；王天笑；张雪；丁英卓；闫莉；江峰；何鲜桂；黄建南；李琴 |
| AUTHORS： | XI Yufei， WANG Tianxiao，ZHANG Xue，DING Yingzhuo，YAN Li，JIANG Feng，HE Xiangui，HUANG Jiannan，LI Qin |
| 关键字： | 研究者发起的临床研究；医疗卫生机构；药品管理；对标分析 |
| KEYWORDS： | investigator-initiated trial； medical and health |
| 阅读数： | 5 次 |
| 本月下载数： | 0 次 |
* 注：未经本站明确许可，任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作！
