TL47: Promotion of involvement of statistician and statistical analysis of risk based monitoring in clinical trials
*Xiaoqiang Xue, Quintiles INC 

Keywords: Risk Based Monitoring, Source Data Verification, Targeted Monitoring

Following Guideline from FDA and EMEA, Risk Based Monitoring (RBM) aims to enhance human subject protection and clinical trial data quality while reducing full Source Data Verification (SDV). Typically people thought RBM is in the domain of site monitoring and data management, nothing to do with statistician, and it is not uncommon to see a certain level of resistance to statistical activity due to lack of understanding the importance of role of statisticians. In this session, we want to share some publications and of examples where the involvement of statistical methods and statistician in RBM improved targeted monitoring by increasing the sensitivity and specificity so that subject safety is better ensured and the data quality can be improved while the monitoring resource is reduced.