ID

37802

Beschrijving

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 Death Table contains one record per PatID.1,2 When legacy data have conflicting reports, please make a local determination as to which to use. There is typically a 1-2 year lag in death registry data. Note: For efficiency death data is captured in 2 tables: Death: the record that characterizes the death date and source of that information Cause of Death: the cause(s) of death associated with the death record These 2 tables are linked by PatID. All Cause of Death records have a matching PatID in the Death Table. PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Link

www.sentinelsystem.org

Trefwoorden

Versies (4)

1. 11-01-17 11-01-17 -
2. 29-01-17 29-01-17 -
3. 25-08-19 25-08-19 -
4. 25-08-19 25-08-19 -

Houder van rechten

FDA's Sentinel Initiative

Geüploaded op

25 augustus 2019

DOI

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Licentie