ID
37804
Description
Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Procedure Table contains one record per unique combination of PatID, EncounterID, PX, and PX_CodeType. This table should capture all uniquely recorded procedures for all encounters.
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Versions (4)
- 1/11/17 1/11/17 -
- 1/29/17 1/29/17 -
- 8/25/19 8/25/19 -
- 8/25/19 8/25/19 -
Copyright Holder
FDA's Sentinel Initiative
Uploaded on
August 25, 2019
DOI
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License
Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model Procedure
Sentinel Common Data Model Procedure
- StudyEvent: ODM
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