Standard No.:	T/CAS 905-2024
English Name:	Quality control standards for on-site implementation of vaccine clinical trials
Chinese Name:	疫苗临床试验现场实施质量控制工作规范
Chinese Classification:	C10    Pharmaceutical in general
Professional Classification:	T/    Social Organization Standard
Source Content Issued by:	Vaccine Industry Association
Issued on:	2024-07-12
Implemented on:	2024-7-12
Status:	valid
Target Language:	English
File Format:	PDF

本文件提供了对疫苗临床试验现场进行质量控制工作的组织管理、人员资质、质控内容、质控流程、质控计划、质控实施、问题分析及处理等标准。
本文件适用于疫苗临床试验现场在开展注册疫苗临床试验过程中实施的内部质量控制工作。非注册疫苗临床试验可参考本文件执行。