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TransCelerate RBM Volume II 15JUL2014

TransCelerate’s Risk-Based Monitoring (RBM) project has been productive in the first half of 2014. The purpose of RBM Update Volume II is to share new and relevant information on the accomplishments of the RBM workstream including the following: RACT version 2.0 released on April 29, 2014 Central Monitoring Capability Technology Considerations to Enable RBM External Engagement Upcoming Deliverables in…

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TransCelerate RBM Volume I 27JAN2014

TransCelerate’s Risk-Based Monitoring (RBM) project had a very productive year in 2013. Subsequent to publishing the Position Paper on Risk-Based Monitoring Methodology in May 2013, we have actively worked to network the concepts and embarked on piloting and/or assessing experience among companies that implemented the methodology. The purpose of this RBM Update document is to share the following information…

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TransCelerate RBM Position Paper 30May2013

Current On-site Monitoring practices are frequency-based, conform to a prescribed monitoring visit schedule, and provide generalized quality control at investigational sites. Although this practice does provide a level of control, advances in risk-based approaches and technology provide an opportunity for a more holistic and proactive approach through Off-site and Central Monitoring and a targeted approach to On-site Monitoring. By…

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