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The Quality by Design Aspects of Risk-Based Monitoring — SDV, SDR and the Role of the CRA

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Part of laying the foundation for a successful risk-based monitoring (RBM) program is training clinical research associates (CRAs) on what data needs to be reviewed on site, and how much of it. RBM industry experts Andy Lawton and Mary Mills both presented at this year's SCOPE Summit on quality by design (QbD) aspects, as part of the translating quality and risk assessment for RBM track. In this video, Andy and Mary discuss the issues and challenges CRAs face when it comes to source data verification (SDV) and source data review (SDR) determination.

*Andy Lawton is head of clinical data management at Boehringer Ingelheim. *Mary C. Mills, R.N. is president of Mary Mills and Associates.


VIDEO—Risk-Based Monitoring: Do CRA's underestimate issues in SDR & overestimate in SDV? @Boehringer #clinicaltrials

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