Consideration on the on-site inspection of vaccine clinical trial
LI Jian-ming
WANG Jia-nan
XIE Qin
CAO Cai
Abstract：The clinical trial on vaccine is applicable mainly for healthy individual (mostly for children). It has special characteristics, such as many subjects, large trial place, and strict management requirement of vaccine cold chain. According to Provisions for Drug Registration released on October 2007, SFDA implemented on-site inspection to the disease control center who is recently applying for conducting the clinical trials on vaccine from this year. This article explores the problems during the clinical trial on vaccine and the standard operation of its trial institutions, so as to provide for future reference.
Keywords：vaccineclinical trialon-site inspection
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：3( 1935-1936,1953 )