Interactive Reporting for Safety Monitoring


Data monitoring to ensure patient safety is an important process in clinical trials. An independent data monitoring committee (DMC) reviews safety data periodically to interpret findings and assess various safety signals. Sponsors typically provide static reports that include tables, listings, and figures (TLFs) to help with this assessment. However, these static reports may not offer quick access to information for specific data points, requiring DMC members to navigate multiple pages or request additional details from the sponsor. To help DMC members review process, we developed an end-to-end process and tools to create interactive reports with drill down options using open-sourced R packages. Using ADaM data as input, these tools can generate interactive reports that the DMC can use to get easy access to additional details on-demand resulting in efficient review and enhanced user experience.

Presented at 2023 Conference