ABSTRACT
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.
ABSTRACT
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.