This is the foundational paper that describes TransCelerate’s model risk-based monitoring (RBM) methodology and the shift from On-Site monitoring and Source Data Verification (SDV) to comprehensive, analytics-based Centralized and Off-site monitoring.

After publishing the RBM Methodology Position Paper in 2013, the RBM team worked to network the concepts and embarked on piloting and assessing experience among those companies that piloted the methodology. The purpose of this paper is to share feedback from TransCelerate Member Companies on their experiences with RBM.

This paper reflects on the first half of 2014, and shares new and relevant information on the accomplishments of the RBM team, including the Risk Assessment and Categorization Tool (RACT), Centralized monitoring capability, technology considerations and external engagement.

This update explores outputs in the second half of 2014, and reveals new findings on the accomplishments of the RBM team, including publications that further the understanding of RBM, Q2 quantitative performance metrics, external engagement updates, and upcoming deliverables in 2015.

This update looks at tangible outputs during the first half of 2015, and addresses frequently asked questions, RACT best practices, quantitative performance metrics, external engagement updates and deliverables for the remainder of 2015.

This paper examines RBM outputs and initiative activities in the second half of 2015, and shares insights on the eight quantitative metrics associated with how RBM is working. The paper also highlights some recently completed work from the team, such as the Risk Indicator Library and new external papers.