Methods, Data, & Tools

Sentinel uses various methods and tools to support the evaluation of medical products. U.S. Food and Drug Administration (FDA) scientists use Sentinel data to strengthen and complement their other data sources, such as adverse event reports, published study results, and clinical trials. The FDA uses this information to inform regulatory decisions about medical product safety. Find additional information, guidance, and code on the Sentinel Developer’s Website.


Sentinel Resources for Investigators

Sentinel has many resources available to help investigators understand and use Sentinel’s analytic tools and the Sentinel Common Data Model. Below are some of our most important resources.

Routine Querying System

Version 10.4.0
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 7.0.3
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 7.1.0 and 8.0.0
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 IBM MarketScan® Research Databases (MarketScan) into the Sentinel Common Data Model

Sentinel and IBM Watson Health partnered together to make SAS code available for transforming the IBM MarketScan® Commercial and Medicare Supplemental 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.

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.

Sentinel Query Builder Standalone Application

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).