中国中医科学院广安门医院临床研究者对GCP法规熟悉程度调查  

Investigation on Degree of Familiarity of GCP in Guang'anmen Hospital of China Academy of Chinese Medical Sciences

作　　者：赵兰英[1] 董宇[1] 连凤梅[1] 王静[1] 刘萍[1] 刘北松[1] 李勇[1] 吴萍[1] 

机构地区：[1]中国中医科学院广安门医院国家药物临床试验机构,北京100053

出　　处：《中国中医药信息杂志》2015年第7期1-3,共3页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家科技重大专项-重大新药创制(2013ZX09303301)

摘　　要：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”）临床研究者对“药物临床试验质量管理规范”（GCP）知识的掌握程度。方法调查对象为广安门医院所有具有临床试验资格并有GCP证书的临床研究者，共计338名，涉及18个临床专业科室和药物临床试验机构办公室工作人员。于2014年6月23－27日，采取书面答卷形式进行调查，内容包括4个名词解释和36个选择题，均为GCP相关内容。结果338名研究者均能准确解释4个名词的概念，能全部正确回答选择题的研究者57名（16.86%），答错1道选择题141名（41.72%），答错2道选择题89名（26.33%），答错3～4道选择题39名（11.54%），答错5道及以上选择题12名（3.55%）。结论广安门医院具有临床试验资格并有GCP证书的临床研究者对GCP法规掌握情况较为满意，今后还应加强针对性强和形式多样的培训，以提高整体掌握GCP法规的水平。Objective To investigate the mastery degree of GCP （Good Clinical Practice） in Guang’anmen Hospital of China Academy of Chinese Medical Sciences （hereinafter referred to as“Guang’anmen Hospital”）. Methods Totally 338 clinical researchers, covering 18 clinical professional sections and medical clinical trial institutions, in Guang’anmen Hospital with both qualification of clinical trials and GCP certificate were investigated in 23th-27th June 2014. The investigation was in the written answer sheet form, including four noun explanations and 36 multiple choice questions, which were related to GCP. Results 338 researchers could accurately explain the concepts of 4 nouns, and 57 （16.86%） researchers could do all multiple choice questions correctly. 141 （41.72%） researchers chose 1 wrong answer and 89 （26.33%） researchers chose 2 wrong answers. 39 （11.54%） researchers failed to answer 3-4 questions. Only 12 （3.55%） researchers failed to answer 5 or more questions. Conclusion The mastery degree of clinical researchers with qualification of clinical trials and GCP certificate in Guang’anmen Hospital is satisfied. In the future, pertinence and diverse training should be strengthened, in order to improve the overall level of the mastery degree of GCP.

关 键 词：药物临床试验质量管理规范 临床研究者 知识问答 培训 

分 类 号：R2-03[医药卫生—中医学]