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Risk Based Monitoring

Rationale

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences. In fact, research indicates that 100% SDV is not effective at identifying material risk. Still, monitoring approaches remain unchanged.

By developing a model approach for risk-based monitoring of clinical trials, TransCelerate’s objective is to both enhance patient safety and ensure the quality of clinical data.

Benefits

The resource solutions generated by the Risk Based Monitoring Initiative could lead to improvement in data quality and patient safety for clinical trials and reduction in effort expended on low-value activities. In addition, adoption of the Initiative’s approach to Risk Based Monitoring could lead to cost reductions through more focused centralized monitoring activity and targeted on-site monitoring.

Available Assets

To find out more our Information Materials, Methodology Papers and Initiative Updates click to our Initiative Assets below.

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