摘要
试验用药/械的管理是贯穿于药物/器械临床试验全过程的重要环节,规范化的药物/器械管理能够为受试者安全和试验结果科学可靠保驾护航。为加强其管理,国内很多临床试验机构成立了按照国家《临床试验质量管理规范》(GCP)进行管理的中心药房。GCP中心药房作为临床试验机构的组成部分,不但要确保试验用药/械各环节管理规范,更要保证临床试验按照GCP的要求进行。本文以我院GCP药房为基础探讨中心药房的规范化管理、药/械管理要点和皮肤科临床试验药/械管理的特点。
As the core of clinical trials,the management of drugs/apparatus penetrates the whole process of clinical trials.Standardized drug/device management can ensure the safety of subject and the authenticity and reliability of trial data.In order to enhance the management of drugs/apparatus,many clinical trial institutions in China have established central pharmacies according to good clinical practice(GCP).GCP pharmacy as an integral part of the clinical trial institution should ensure not only the standardized management of clinical trial drugs/apparatus,but also that clinical trials are carried out in accordance with the requirements of GCP.Based on the work of GCP pharmacy in our hospital,this paper discussed the standardized management of the GCP pharmacy,key points of drug/apparatus administration and features of clinical trial drug/apparatus management in dermatology.
作者
时歆未
崔贞
柴蓉蓉
朱全刚
SHI Xinwei;CUI Zhen;CHAI Rongrong;ZHU Quangang(PhaseⅠClinical Trial Center of Shanghai Skin Disease Hospital,Shanghai 200443,China)
出处
《上海医药》
CAS
2023年第19期40-43,70,共5页
Shanghai Medical & Pharmaceutical Journal
基金
上海市科委课题(20DZ2255200,21S21900900,23S21900800)。
关键词
GCP中心药房
规范化管理
临床试验
GCP central pharmacy
standardized management
clinical trials
