Question: A research team is implementing an RBM strategy for their new clinical trial on a novel asthma medication. The team has categorized each case report
A research team is implementing an RBM strategy for their new clinical trial on a novel asthma medication. The team has categorized each case report form (CRF) and investigator site with a risk level of high, medium, or low, based on factors such as previous study performance and the significance of the data collected (e.g., adverse events, compliance with inclusion/exclusion criteria). Considering the principles of RBM, which of the following steps is crucial for the successful application of RBM in this trial? A Combining on-site monitoring activities with central data review to observe site operations and data collection practices effectively. B Conducting a thorough risk assessment to identify critical data elements and processes, and defining a clear plan for monitoring, including the frequency and methods of data review. C Applying 100% source data verification (SDV) for all high-risk data points across CRFs to ensure comprehensive data integrity. D Focusing all resources on high-risk CRFs and investigator sites to minimize errors and promote data quality
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