What is the FDA’s Sentinel System (SS)?

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Starting with a mini-sentinel pilot program, the Sentinel initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the performance of FDA-regulated medical products. Working with public, academic, and private entities, the FDA developed the sentinel system and launched in 2016. The Sentinel System obtains information from existing electronic healthcare data from multiple sources to assess the safety of approved medical products. The efforts of integrating the Sentinel System into the FDA’s regulatory programs enables the administration to evaluate some safety signals in the postmarket setting more effectively by using Sentinel’s automated tools.

The most updated Sentinel Common Data Model (SCDM) 7.0.0 consists of five data types, including administrative data, clinical data, registry data, inpatient data and Mother-infant linkage data. The five years strategy (2019-2023) for the Sentinel System stated that by 2023, the FDA envisions a more robust Sentinel System: a transformative, multi-purpose national database and scientific resource center for evidence-generation that a wide array of stakeholders will use to inform all aspects of healthcare decision-making.

To realize this vision, the FDA will pursue five strategic aims. First, enhance and expand the Sentinel System’s foundation, including data, infrastructure, operations and technology. Second, augment its safety analysis capabilities using advances in data science and signal detection. Third, use the Sentinel System to accelerate access to and broaden the use of real-world data (RWD) for real-world evidence (RWE). Fourth, broaden the Sentinel System’s ecosystem of stakeholders to pursue the vision of a national resource. Finally, disseminate knowledge and advance regulatory science to encourage innovation and meet the administration’s scientific needs.

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