ID

37801

Beschreibung

Sentinel: Overview and Description of the Common Data Model v6.0 "The primary goal of the Sentinel pilot 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. This data model is freely available to all. 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

Stichworte

Versionen (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 -

Rechteinhaber

FDA's Sentinel Initiative

Hochgeladen am

25. August 2019

DOI

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