CAJ | 학술논문

制订药物临床试验中知情同意书的设计及签署要素标准，调查首都医科大学附属北京佑安医院63项药物临床试验知情同意书的设计及2265份知情同意书的签署情况，分析各要素的出现率，该院知情同意书的设计及签署基本符合《药物临床试验质量管理规范》的要求，但仍存在要素的缺失和签署不规范的现象，针对发现的问题进行分析后提出改进对策：制定相关标准操作流程，加强知情同意书的管理，加强制度建设和教育培训，促进医院伦理建设，切实保护受试者的权益。
제정약물림상시험중지정동의서적설계급첨서요소표준，조사수도의과대학부속북경우안의원63항약물림상시험지정동의서적설계급2265빈지정동의서적첨서정황，분석각요소적출현솔，해원지정동의서적설계급첨서기본부합《약물림상시험질량관리규범》적요구，단잉존재요소적결실화첨서불규범적현상，침대발현적문제진행분석후제출개진대책：제정상관표준조작류정，가강지정동의서적관리，가강제도건설화교육배훈，촉진의원윤리건설，절실보호수시자적권익。
Items of design and signature from clinical trial drugs were made , the occurrence ratio of every item in 2265 informed consent form ( ICF) from 63 clinical trial drugs in Beijing Youan Hospital affiliated to Capital U-niversity of Medical Sciences were analyzed , and items with lower occurrence ratio were explored .Generally , the design and signature of ICF met the requirement of GCP .However , there were some defects of ICF and antonym of signature .Based on the analysis on the problems , some measures were put forward:formulate relevant standard op-erating procedures , strengthening the management of informed consent , and strengthen the system construction and education training , promote the hospital ethics construction , to protect the rights and interests of the subjects .