Key points of serious adverse event and protection of patients in ophthalmic clinical trials during novel coronavirus pneumonia outbreak / 中华实验眼科杂志
Chinese Journal of Experimental Ophthalmology
; (12): 273-275, 2020.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-865264
Biblioteca responsável:
WPRO
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.
Texto completo:
Disponível
Contexto em Saúde:
ODS3 - Meta 3.3 Acabar com as doenças tropicais negligenciadas e combater as doenças transmissíveis
Problema de saúde:
Pneumonía
Base de dados:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Chinês
Revista:
Chinese Journal of Experimental Ophthalmology
Ano de publicação:
2020
Tipo de documento:
Artigo