ID
37956
Descrizione
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 SCDM: Enrollment Table Structure: The SCDM Enrollment Table has a start/stop structure that contains records on continuous enrollment periods. Members with medical coverage, drug coverage, or both should be included. A unique combination of PatID, Enr_Start, Enr_End, MedCov, DrugCov, and Chart identifies a unique record. A break in enrollment (of at least one day) or a change in the medical coverage, drug coverage, or chart abstraction flag variables should generate a new record.
collegamento
Keywords
versioni (5)
- 07/01/17 07/01/17 -
- 29/01/17 29/01/17 -
- 15/01/19 15/01/19 - Sarah Riepenhausen
- 02/09/19 02/09/19 -
- 02/09/19 02/09/19 -
Titolare del copyright
FDA's Sentinel Initiative
Caricato su
2 settembre 2019
DOI
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Licenza
Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model Enrollment
Sentinel Common Data Model Enrollment
- StudyEvent: ODM
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