Key points of serious adverse eventand protection of patients in ophthalmic clinical trials during novel coronavirus pneumonia outbreak / 中华实验眼科杂志

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.