CAJ | 학술논문

目的：了解中国中医科学院广安门医院(以下简称“广安门医院”)临床研究者的状况及需求。方法采用自填式问卷调查方式,以广安门医院临床专业所有持“药物临床试验质量管理规范”(GCP)证书的医护人员为调查对象,就对科室临床试验质量的认可程度、参与的主动性及对GCP知识需求3个方面进行调查。数据采用SPSS11.5统计软件进行分析。结果95.6%研究者认为临床试验过程规范,89.9%研究者认为临床试验质量高,绝大多数研究者主动参与临床试验(86.9%),认为其有助于提高科研能力和发表学术论文。结论绝大多数研究者熟悉GCP知识,能主动参与临床试验,并希望得到更多培训。
목적：료해중국중의과학원엄안문의원(이하간칭“엄안문의원”)림상연구자적상황급수구。방법채용자전식문권조사방식,이엄안문의원림상전업소유지“약물림상시험질량관리규범”(GCP)증서적의호인원위조사대상,취대과실림상시험질량적인가정도、삼여적주동성급대GCP지식수구3개방면진행조사。수거채용SPSS11.5통계연건진행분석。결과95.6%연구자인위림상시험과정규범,89.9%연구자인위림상시험질량고,절대다수연구자주동삼여림상시험(86.9%),인위기유조우제고과연능력화발표학술논문。결론절대다수연구자숙실GCP지식,능주동삼여림상시험,병희망득도경다배훈。
ObjectiveTo understand the status and requirement of the clinical researchers in Guang’anmen Hospital of China Academy of Chinese Medical Sciences (hereinafter referred to as Guang’anmen Hospital).MethodsSelf-filling questionnaire was used. All medical care personnel in the clinical specialty with the GCP qualification were set as respondents. The three aspects of recognition degree of clinical trials quality, initiative of participation and knowledge demand for GCP were investigated. Data were analyzed through SPSS11.5.Results 95.6% of clinical researchers considered that the course of clinical trial was legal;89.9% of clinical researchers believed that the quality of clinical trial was good. Most clinical researchers participated in the clinical trials actively (86.9%) and they considered that the trials were helpful for them to enhance research ability and to issue paper.Conclusion Clinical researchers are familiar with GCP knowledge and can participate in the clinical trials actively. They still expect to learn more.