Analysis of the concerns and problems found by the U.S.FDA bioresearch monitoring program in clinical investigator inspection
JIANG Min
ZHAO Shu-hua
LIU Xiao-hong
FU Zhi-ying
YUAN Yan-nan
Abstract：The innovation ability of Chinese pharmaceutical industry has been significantly improved.Simultaneous declaration at home and abroad has become a new strategy for domestic enterprises to declare innovative drugs.Investigators are also facing more on-site inspections by U.S.FDA bioresearch monitoring program(BIMO).Based on the practical experience of BIMO inspection,this study discussed the process,key points and common problems of BIMO inspection,and analyzed the causes of the problems,in order to assist GCP centers,investigators and sponsors to deal with BIMO inspection.
Keywords：U.S.FDAbioresearch monitoringinvestigatordrug clinical trial
Publication Date：2024-08-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1687-1692 )