Risk Based Monitoring
In line with recent EMEA and FDA guidance and in support of the industry movement towards remote monitoring, Chiltern has developed a robust Risk Based Monitoring (RBM) model for clinical studies based on direct experience. This strategic approach moves from a classical 100% source document review at site to a more effective targeted data monitoring model, where specific study risks and site performance are continuously assessed. Recognizing that early and ongoing integrated data review by all functions is essential to an effective RBM strategy, Chiltern has produced a customized data monitoring model that is tailored for each individual study site, concentrating resources on risk to data and patient safety.
Critical to the success of the RBM process is the close working relationship of the core team to ensure the data is of high quality. The Project Manager (PM) has oversight of the Integrated Data Quality Plan (IDQP): a plan that clearly details the holistic approach to managing and cleaning the data, approved by all stakeholders during study set up. The PM works closely with the entire study team, including the clinical monitoring team, to develop tailored site management strategies ensuring data quality and excellent site relationships.
Chiltern’s unique tracking tools cover all aspects of site study management to ensure the PM and the core team have immediate access to detailed site level metrics. Understanding that early access to data is critical to perform remote monitoring and data review as well as identifying any site level issues, Chiltern’s processes and tools allow fast and efficient data review at all levels. In conjunction with all operational functions, the PM maintains close observation of site progress and takes action as required to ensure that data quality is optimized whilst maintaining motivated and productive site staff. As a result, cost reduction and higher data quality are delivered through an efficient use of on-site resources and a more focussed data review.