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对南通大学附属医院眼科门诊新开展的3种滴眼液的药物临床试验方案设计及其实施情况、受试者选择、知情同意过程、药物和资料管理等质量控制环节进行回顾。2种药物临床试验得以完成,1种因故暂停。通过试验,摸索出眼科门诊进行药物临床试验工作的新流程和质量控制环节,涵盖试验方案设计、标准操作程序制定及执行、受试者甄选与检查、药物与数据的管理以及申办方监查等方面。良好的方案设计、完善的标准操作规程、专人负责和严格按照临床试验质量管理规范进行是保证眼科门诊进行滴眼液药物临床试验质量的关键。
To review the design and implementation of three kinds of drug clinical trial programs of ophthalmology outpatient department of Nantong University Hospital and its implementation, subjects selection, informed consent process, drug and data management and other aspects of quality control. Two kinds of drug clinical trials have been completed, a kind of suspension for some reason. Through the trial, we explored the new procedures and quality control aspects of the clinical trial of ophthalmology clinics, covering the design of the trial program, the development and implementation of standard operating procedures, the selection and examination of the subjects, the management of the drugs and data, and the examination of the sponsor aspect. Good program design, improve the standard operating procedures, hand responsible and in strict accordance with the quality of clinical trial management standards is to ensure that eye clinics ophthalmic drug clinical trials of the quality of the key.