Sentinel Data Quality Review and Characterization Distributed Programs
February 27, 2025
Preface
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 Association’s (FDA) medical product safety questions. To create the Sentinel Distributed Database, each Data Partner transforms local source data into the Sentinel Common Data Model (SCDM) format. The Sentinel Data Quality Review and Characterization Programs are thjen used by the Sentinel Operations Center to ensure that only the highest quality data is used in the Sentinel Distributed Database. The Sentinel Data Quality Review and Characterization Programs are described in Table 0.1:
| Package | Description |
|---|---|
| Sentinel Data Quality Assurance and Characterization Program Package (QA Package) | A distributed program package used to assess the quality of data held in the Sentinel Distributed Database. |
| Sentinel Mother-Infant Linkage Data Quality Assurance Package (QA MIL Package) | A distributed program package used to assess the quality of the data in the Sentinel Distributed Database Mother-Infant Linkage table. |
| Mother-Infant Identification Package (MID Package) | A distributed program package used to identify cohorts of mothers and infants for linkage in the Mother-Infant Linkage table. This package is available as a standalone package but is more typically embedded within the QA Package. |
| SCDM Snapshot Program Package | A distributed program package used to characterize data found within the Sentinel Distributed Database. This package is available as a standalone package but is more typically embedded within the QA Package and QA MIL Package. |
| Sentinel Common Components | A distributed program package used to provide refresh specific metadata to distributed packages run against the SDD—e.g., the Query Request Package (QRP). A standalone package is available, it is more typically embedded within the QA Package and QA MIL Package |
This documentation describes the Sentinel Data Quality Review and Characterization Programs and provides instructions for configuring and running these programs. This documentation can be navigated using the Table of Contents on the left side of the documentation. Clicking on each chapter title will reveal the sections within that chapter. The documentation is divided into five parts:
- Part I: General Principles
- Part II: Sentinel Data Quality Assurance Package
- Part III: Sentinel Mother-Infant Linkage Data Quality Assurance Package
- Part IV: Sentinel Common Components
For details on package versions and updates, please see Tables 3.1, 9.1, and 15.1.
Disclosure
The Sentinel System is sponsored by the U.S. Food and Drug Administration (FDA) to proactively monitor the safety of FDA-regulated medical products and complements other existing FDA safety surveillance capabilities. The Sentinel System is one piece of FDA’s Sentinel Initiative, a long-term, multi-faceted effort to develop a national electronic system. Sentinel Collaborators include Data and Academic Partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise. The Sentinel Operations Center is funded by the FDA through the Department of Health and Human Services (HHS) Task order 75F40119D10037.