临床研究协调员递交伦理审查资料常见问题剖析及对策探讨

Analysis and discussion on the problems and countermeasures of submitting ethical review materials by clinical research coordinator

随着我国加大了对临床试验的支持力度,国内临床试验项目数量快速增长,临床试验整体水平不断提升,临床研究协调员作为临床试验过程中医疗机构、申办方和各研究者之间的沟通协调人员,逐渐扮演着越来越重要的角色。近年来,在临床研究协调员行业快速发展的同时,其在递交伦理审查资料工作中也暴露出不熟悉各研究中心递交资料要求,递交资料不及时,沟通协调不到位以及规范化培训不完善四个方面问题。通过对上述问题进行剖析,并结合多年的伦理工作实践经验,有针对性地提出了临床研究协调员应加强规范化培训,轮转伦理办公室以及注重综合素质提升三个方面对策,以期推动伦理审查工作高质高效的可持续发展,提高临床试验质量。

With the increased support for clinical trials in China,the quantity of domestic clinical trials is growing rapidly and the overall level of clinical trials is continually improving.As the coordinator among medical institutions,sponsors,and investigators during clinical trials,clinical research coordinator is gradually playing a more and more important role.In recent years,with the rapid industrial development of clinical research coordinator,there are problems from four aspects in submitting ethical review materials by clinical research coordinator:being unfamiliar with the submission requirements of each research center,belated submission,inadequate communication and coordination and incomplete standardized training.Through analyzing the above problems and based on years of practice experience,this paper puts forward three countermeasures to strengthen standardized training,rotate to ethics office and pay attention to the improvement of comprehensive quality,so as to promote the sustainable development of ethical review with high quality and efficiency and improve the quality of clinical trials.