新型冠状病毒肺炎防控期间眼科临床试验流程管理及受试者随访防护要点  

Key points of serious adverse event and protection of patients in ophthalmic clinical trials during novel coronavirus pneumonia outbreak

作　　者：张鹏[1] 卢颖毅[1] 宋爽[1] 喻晓兵[1] 戴虹[1] Zhang Peng;Lu Yingyi;Song Shuang;Yu Xiaobing;Dai Hong(Department of Ophthalmology,Beijing Hospital,National Center of Gerontology,Insitute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]北京医院眼科,国家老年医学中心,中国医学科学院老年医学研究院,100730

出　　处：《中华实验眼科杂志》2020年第3期273-275,共3页Chinese Journal Of Experimental Ophthalmology

摘　　要：新型冠状病毒肺炎(COVID-19)疫情的防控是目前的头等大事,防控期间的各种措施对临床试验的正常进行将会带来不同程度的影响,而眼科临床试验中各种检查需近距离接触,有较高的交叉感染风险。本文从重大突发公共卫生事件下的临床试验项目的准则,疫情期临床试验工作的管理,包括受试者随访、疫情性严重不良事件(SAE)处理、申办方合作办的管理要求,以及眼科临床试验过程中对环境、受试者、检查者以及检查设备的要求和管理细则等方面提出建议,希望对新型冠状病毒感染防控期间的眼科临床试验研究者及受试者中有所帮助。The prevention and control of novel coronavirus pneumonia is the most priority recently,and various measures during the prevention and control period will have varying degrees of impact on the implement of clinical trials.However,various examinations in ophthalmological clinical trials need close contact between operators and patients,which put us at risk of cross-infection.This paper indicated some suggestions based on the criteria of clinical trials under major public health emergencies,the management of clinical trials during epidemic period,including the follow-up of subjects,the treatment of epidemic serious adverse event(SAE)and the management requirements of co-sponsors,as well as the requirements and management principles for environment,subjects,examiners and inspection equipment in the process of ophthalmic clinical trials.It may be helpful to the ophthalmic clinical trial researchers and subjects during the period of novel coronavirus infection.

关 键 词：新型冠状病毒 临床试验 随访管理 眼科 疫期防控 

分 类 号：R5[医药卫生—内科学]