Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment.

ABSTRACT:

Background

Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted.

Methods

Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source da

SUBMITTER: Kondo H 

PROVIDER: S-EPMC8238712 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature