Oversight of Clinical Investigations-A Risk Based Approach to Monitoring

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This guidance “makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical investigator (CI) conduct and performance in investigational new drug (IND) studies conducted under 21 CFR part 312 or investigational device exemption (IDE) studies conducted under 21 CFR part 812. The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively.”

Per FDA, “there is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality. For example, incorporation of centralized monitoring practices, where appropriate, should improve a sponsor’s ability to ensure the quality of clinical trial data. Several publications suggest that certain data anomalies (e.g., fraud, including fabrication of data, and other non-random data distributions) may be more readily detected by centralized monitoring techniques than by on-site monitoring. It has been suggested that a statistical approach to central monitoring can “help improve the effectiveness of on-site monitoring by prioritizing site visits and by guiding site visits with central statistical data checks,” an approach that is supported by illustrative examples using actual trial datasets. A recent review of on-site monitoring findings collected during a multi-center international trial also suggests that centralized monitoring can identify the great majority of on-site monitoring findings. The review determined that centralized monitoring activities could have identified more than 90% of the findings identified during on-site monitoring visits.”

Download the guidance here.