Sentinel Data

Funder: United States Food and Drug Administration (FDA)

PI: Sengwee Darren Toh

Year Funded: 2008

Project Summary

The Sentinel System is comprised of health care organizations, known as Data Partners, that have medical billing information and electronic health records. This data is collected routinely with every healthcare encounter and is used to answer the U.S. Food and Drug Administration's (FDA) medical product safety questions. Each Data Partner keeps their own data and controls who can access it.

Each Data Partner runs analyses through a data program and sends the identifiable results to the Sentinel Operations Center. The Sentinel System’s distributed approach maintains patient privacy and data security.

Project Details

The distributed approach is important for creating larger datasets so the FDA can study rare adverse events or drugs used in small populations. It also requires a standardized data structure. This standardized data structure is the Sentinel Common Data Model. Data Partners transform their data locally into the Sentinel Common Data Model format. During this transformation, Data Partners remove or mask directly identifiable patient information. The standardized format enables them to execute routine querying tools, enabling the FDA to conduct studies quickly, compared to writing new programs for each new study.

The Sentinel Distributed Database is the collection of harmonized datasets from many different Data Partners. These datasets are all in the Sentinel Common Data Model format.

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