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

Link

www.sentinelsystem.org

Keywords

  1. 1/11/17 1/11/17 -
  2. 1/29/17 1/29/17 -
  3. 8/25/19 8/25/19 -
  4. 8/25/19 8/25/19 -
Uploaded on

January 11, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0

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Sentinel Common Data Model Death

Sentinel Common Data Model Death

Death
Description

Death

Alias
UMLS CUI-1
C0011065
Unique member identifier
Description

Arbitrary person-level identifier. Used to link across tables. Note: 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.

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Imputed Date of Death
Description

When DeathDt is imputed, this variable indicates which parts of the date were imputed.

Data type

integer

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0750572
Death information
Description

Source of death information.

Data type

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1955348
Confidence
Description

Confidence that the patient drawn from the Source data represents the actual patient (contrasts with Confidence in the Cause of Death table).

Data type

text

Alias
UMLS CUI [1]
C1704726

Similar models

Sentinel Common Data Model Death

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Death
C0011065 (UMLS CUI-1)
Patient ID
Item
Unique member identifier
text
C2348585 (UMLS CUI [1])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Imputed Date of Death
integer
C1148348 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Code List
Imputed Date of Death
CL Item
Both month and day imputed (1 )
CL Item
Day imputed (2 )
CL Item
Month imputed (3 )
CL Item
Not imputed (4 )
Item
integer
C0011065 (UMLS CUI [1,1])
C1955348 (UMLS CUI [1,2])
Code List
Death information
CL Item
Other, locally defined (1 )
CL Item
National Death Index (2 )
CL Item
State Death files (3 )
CL Item
Tumor data (4 )
Item
Confidence
text
C1704726 (UMLS CUI [1])
Code List
Confidence
CL Item
Excellent (1 )
CL Item
Fair (2 )
CL Item
Poor (3 )

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