ID

19579

Description

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. 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." Sentinel Collaborating Institutions maintain data resources and provide technical, scientific, and methodological expertise as needed to meet the public health surveillance requirements of Sentinel. The Collaborating Institutions also participate as members of the Planning Board, the Safety Science Committee, the Sentinel Operations Center (SOC), and various Sentinel workgroups. Sentinel Common Data Model "The SOC Data Core coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data. The SOC Scientific Systems Division manages creation of the Sentinel Distributed Database (SDD) using the SCDM, and maintains complete documentation of the implementation and characteristics of the SDD. The SDD refers to the data held and maintained by the Data Partners in the SCDM format. The SCDM was developed in accordance with the SCDM Guiding Principles and was modeled after the HMO Research Network Virtual Data Warehouse. The SCDM currently includes 13 tables that represent information for the data elements needed for Sentinel activities. Records are linked across tables by a unique person identifier, PatID. Details of the 13 tables are provided in this document. An additional 13 Summary Tables are created from the ""parent tables"" and are also described in this document. Revisions and enhancements to the SCDM are expected, including the addition of clinical information, incorporation of other data types and sources, and revisions based on lessons learned from use of the SDD. This may include adopting variables and formats developed by other programs." 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

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www.sentinelsystem.org

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Versions (4)

1. 11/01/2017 11/01/2017 -
2. 29/01/2017 29/01/2017 -
3. 25/08/2019 25/08/2019 -
4. 25/08/2019 25/08/2019 -

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11 janvier 2017

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