Sentinel Tools

Funder: United States Food and Drug Administration (FDA)

PI: Sengwee Darren Toh

Year Funded: 2008

Project Summary

Sentinel’s standardized analytic tools enable a range of pharmacoepidemiologic study designs to be performed on any data in the Sentinel Common Data Model (SCDM) format. These analytic tools are standardized SAS® statistical software code packs and may be parameterized for custom analyses. Sentinel’s use of standardized tools enables faster and reproducible analyses in a multi-site setting. Sentinel’s analytic tools are publicly available and accompanied by user documentation.

Additionally, the Sentinel Operations Center distributes a quality assurance tool. This program checks the data according to the standards specified in the SCDM.

Project Details

Sentinel’s routine querying tools fall into four categories:

1. Signal identification analyses detect new and unsuspected potential safety concerns.
2. Level 1 analyses are descriptive analyses.
3. Level 2 analyses are retrospective inferential analyses.
4. Level 3 analyses are prospective sequential inferential analyses.

Sentinel's data quality assurance tool focuses on three levels of checks.

• Level 1 Check: Is Everything There?
  The package automatically checks the data for completeness and validity, analyzing for items such as missing variables, values, or entire tables.
• Level 2 Check: Do the Data Make Sense?
  This review is also done automatically by the package, evaluating the data for cross-table consistency.
• Level 3 Check: How Does It Look Compared to the Last Extract, Transform, and Load (ETL)?
  Sentinel Operations Center staff carry out this review. They ensure the stability and consistency of the data over time.

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