Standard No.:	T/CAV 003-2023
English Name:	Guidelines for visiting site setting of prophylactic vaccine clinical research
Chinese Name:	预防用疫苗临床研究访视现场设置指南
Chinese Classification:	C10    Pharmaceutical in general
Professional Classification:	T/    Social Organization Standard
Source Content Issued by:	China Vaccine Industry Association
Issued on:	2023-04-10
Implemented on:	2023-4-10
Status:	valid
Target Language:	English
File Format:	PDF

本文件提供了预防用疫苗临床研究访视现场资质、场所、功能分区、现场管理、信息系统等方面的设置指导。
本文件适用于开展以申请注册为目的的预防用疫苗临床研究访视现场设置、建设和维护，上市后预防用疫苗临床研究可参考本文件执行。