Guidance For Risk Based Monitoring

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Guidance for Risk Based Monitoring (RBM) For Clinical Research Associate (CRA) By J. Moti and C. Jones Introduction Clinical Research Associate (CRA) role has tremendously changed over the years. Days of 100% Source document verification (SDV) on every individual data point are long gone. Contract Research Organizations (CRO) are adapting a new model for conducting studies known as Risk-Based Monitoring. Risk-Based Monitoring Risk-Based Monitoring (RBM) also known as centralized monitoring is a process whereby the monitor identifies and targets specific monitoring activities, based on importance and risks. This includes a mixture of on-site responsibilities and remote activities. As illustrated in Figure 1 RMB practices can reduce the…show more content…
Since one of the main roles of a CRA had been is to verify case report form data to actual clinical data, one might worry that the CRA role will diminish and their role is not vital. That concern is unfounded in fact CRAs are more critical than ever, in executing the RBM model. Companies will need to ensure that CRAs are trained and educated to identify risk indicators (5). CRAs will have to dispose of the older “box checking” habits and instead recognize trends from patient to patient. The ideology behind RBM is that, it produces higher quality data with less delay, which has an impact on not only costs, but participant safety (5). Figure 2, compares the CRA role in RBM and the old model (2). Figure 2(2) Item Reviewed RBM Old Model Informed consent Review copies of all signed informed consent documents and ensure consenting process was done according to ICH/GCP guidelines. Review source documentation to confirm the patient’s own signature and proper consenting process was used. Eligibility criteria Verify per source only for Full SDV subjects. Verified per source review of ALL patients. Regulatory documents Create a shadow regulatory file to limit time on-site for SDV. Review of all regulatory documents to ensure maintenance of accurate, current, and complete records while on site. Investigator involvement Discussions via
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