Sentinel Data Quality Review and Characterization Distributed Programs

Sentinel Operations Center

December 14, 2023

Preface

The purpose of this repository is to document the Sentinel Data Quality Review and Characterization Distributed 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 three parts:

• Part I: General Principles
• Part II: QA Package
• Part III: QA MIL Package

For details on package versions and updates, please see Tables 2.1 and 8.1.

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.