CAJ | 학술논문

目的：介绍我院临床试验用药品的管理方法，探讨合理的管理模式。方法从建立试验药品管理制度、建立中心试验药房管理模式、试验用药品管理的标准操作规程和质量控制等方面，阐述我院临床试验用药品的管理。结果从我院实践情况来看，中心试验药房管理模式在对试验用药品的管理上具有显著的优势。结论中心试验药房专人、专职、集中管理试验用药品，保障受试者用药安全，保证药物临床试验结果科学、可靠。
목적：개소아원림상시험용약품적관리방법，탐토합리적관리모식。방법종건립시험약품관리제도、건립중심시험약방관리모식、시험용약품관리적표준조작규정화질량공제등방면，천술아원림상시험용약품적관리。결과종아원실천정황래간，중심시험약방관리모식재대시험용약품적관리상구유현저적우세。결론중심시험약방전인、전직、집중관리시험용약품，보장수시자용약안전，보증약물림상시험결과과학、가고。
Objective To introduce management of clinical trial drugs in our institution,and to discuss a ra-tional management model. Methods Management of clinical trial drugs is stated in establishment of regulatory regime and centre trial pharmacy,SOP of drugs management,and quality control. Results In the practice of our hospital,it is remarkably superior for model of centre trial pharmacy about management of trial drugs. Conclusion Centre trial phar-macy model can safeguard the safety of all trial subjects,and ensure the scientificity and reliability of trial results.