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Engage with Sentinel

Engage with Sentinel
“From the very beginning, Sentinel’s success has been a function of the dynamic and mutually affirming public-private partnership between FDA and the scientific community. From the very first Data Partners who raised their hands to contribute their data to the nation’s first national active drug safety surveillance system, to all the academic partners who developed the initial versions of the common data model and causal inference tools - partnerships have been essential to Sentinel’s success.”
Patrizia Cavazzoni, MD, Director of the FDA Center for Drug Evaluation and Research (CDER)

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Request trainings on Sentinel data, tools, or other areas of interest and we will do our best to accommodate your needs.

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Using Sentinel Data & Tools

Have a question about using Sentinel data or tools? Let us help you.

If you are a contracted partner, government, or FDA, contact us via the contact form.

If you’re a private sector entity, academic institution, or an individual, contact IMEDS via the Reagan-Udall Foundation.


Innovation in Medical Evidence Development and Surveillance (IMEDS)

The Reagan-Udall Foundation for the FDA, an independent 501(c)(3) nonprofit created by Congress to advance regulatory science, has a private-public partnership called IMEDS. IMEDS gives private-sector entities access to a system based on the Sentinel Initiative. This system offers industry, academia, and researchers data that can help:

  • Check safety signals
  • Put in place post-market studies
  • Assess the impact of risk management actions

This is possible through select Data Partners and the Harvard Pilgrim Health Care Institute. Together, these two groups function as the Analytic Center. They help with the analyses of medical product safety evaluations.

Methods, Data, & Tools

Explore Sentinel Tools

Explore the publicly available analytic tools and technical documentation in the Sentinel Git repository.

Routine Querying System

Version 13.1.2
Sentinel routine querying tools are SAS programs designed to run against the Sentinel Common Data Model. They allow rapid implementation of standard queries across the Sentinel Distributed Database.

Data Quality Review and Characterization Programs

Version 8.5.0
Data Quality Review and Characterization Programs help researchers understand the data quality checks conducted in Sentinel. The programs do this by characterizing the data that Data Partners create using the Sentinel Common Data Model rules.

Sentinel Common Data Model

Versions 8.0.0 and 8.1.0
The Sentinel Common Data Model helps researchers understand what data are available. The Sentinel Common Data Model is a standard data structure that allows Data Partners to quickly execute distributed programs against local data.

SAS Code for Transforming the Merative™ MarketScan® Research Databases (MarketScan) into the Sentinel Common Data Model

Sentinel and Merative™ partnered together to make SAS code available for transforming the Merative™ MarketScan® Commercial and Medicare Databases into the Sentinel Common Data Model.

Medicare Fee-for-Service Claims in Sentinel Common Data Model Format

This code pack helps researchers create a Sentinel Common Data Model-compliant version of the Medicare data within the Centers for Medicare & Medicaid Service’s (CMS) Virtual Research Data Center (VRDC). The Sentinel CMS DataMart contains 100% Medicare fee-for-service administrative claims data housed in the CMS VRDC.

Sentinel Query Builder Standalone Application

Version 2.2.0
The Sentinel Query Builder is a web application that allows users to visualize, draft, and create medical product utilization queries. The Sentinel Query Builder allows researchers to do this from a set of pre-defined parameters and convert them into Sentinel query request packages (executable SAS code).

Medicare Claims Synthetic Public Use Files in Sentinel Common Data Model Format Common Data Model

The CMS 2008-2010 Data Entrepreneurs’ Synthetic Public Use Files (SynPUFs) provide researchers a large data set for analysis, based on a 5% sample of the entire CMS fee-for-service population from 2008-2010. Researchers can run Sentinel's tools on this synthetic data to understand the tools’ capabilities.

Routine Querying System Reporting Tool

Version 3.1.1
The Sentinel Routine Querying System Reporting Tool is a SAS program designed to run against the output of the Sentinel routine querying tools. The reporting tool allows uses to aggregate across multiple Data Partner sites, create formatted reports, and generate effect estimates for standard queries.

Have a Question?

Have a question about the Sentinel Initiative or other ways to engage? You can reach out to us via our contact form.