Research Ⅵ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Risk Analysis of Cross-border Changes of Sponsors or Production Sites in the Clinical Research Phase
Objective:To evaluate and analyze the risk changes of cross-border changes in sponsors or production sites,and provide reference for the management of cross-border changes in sponsors and production sites.Methods:Based on the initial risk assessment results of different combination modes of the sponsors and production sites,and the risk re-evaluation results after implementing risk control measures,a comparative analysis was conducted on the changes in the"risk index level"before and after the changes occur between different combination modes.Results and Conclusion:Based on the results of the initial risk evaluation,the risk index levels of two change scenarios were lower after the change than before the change,and based on the results of the risk re-evaluation,the risk index levels of four change scenarios were lower after the change than before the change.
clinical research phasesponsorproduction sitecross-border changerisk analysis
NETL
NSTL
万方数据
