Key points of serious adverse eventand protection of patients in ophthalmic clinical trials during novel coronavirus pneumonia outbreak
10.3760/cma.j.cn115989-20200217-00072
- VernacularTitle: 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
- Author:
Peng ZHANG
1
;
Yingyi LU
1
;
Shuang SONG
1
;
Xiaobing YU
1
;
Hong DAI
1
Author Information
1. Department of Ophthalmology, Beijing Hospital, National Center of Gerontology, Insitute of Geriatric Medicine, Chines Academy Of Medical Science, Beijing 100730, China
- Publication Type:Journal Article
- Keywords:
Novel coronavirus;
Clinical trials;
Follow-up management;
Ophthalmology
- From:
Chinese Journal of Experimental Ophthalmology
2020;38(0):E007-E007
- CountryChina
- Language:Chinese
-
Abstract:
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.
