ID
37815
Description
Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal ofSentinel 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 Encounter Table contains one record per PatID and EncounterID (which reflects a unique combination of PatID, ADate, Provider and EncType). Each encounter should have a single record in the SCDM Encounter Table. Each diagnosis and procedure recorded during the encounter should have a separate record in the Diagnosis or Procedure Tables. Multiple visits to the same provider on the same day should be considered one encounter and should include all diagnoses and procedures that were recorded during those visits. Visits to different providers on the same day, such as a physician appointment that leads to a hospitalization, should be considered multiple encounters. Rollback transactions and other adjustments should be processed before populating this table. Note: Rollback transactions and other adjustments should be processed before populating this table. This may be handled differently by Data Partners and may be affected by billing cycles.
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Versions (4)
- 1/8/17 1/8/17 -
- 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 Encounter
Sentinel Common Data Model Encounter
- StudyEvent: ODM
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