ID

19536

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

Versions (5)
  1. 1/7/17 1/7/17 -
  2. 1/29/17 1/29/17 -
  3. 1/15/19 1/15/19 - Sarah Riepenhausen
  4. 9/1/19 9/1/19 -
  5. 9/2/19 9/2/19 -
Uploaded on

January 7, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC-ND 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Sentinel Common Data Model Demographic

English

Sentinel Common Data Model Demographic

1 forms  
Demographic
Description

Demographic

Alias
UMLS CUI-1
C1704791
Patient ID
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
Birth Date
Description

Date of birth.

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Hispanic?
Description

A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.

Data type

integer

Alias
UMLS CUI [1]
C0086409
Race
Description

Please use only one race value per member. American Indian or Alaska Native = A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment. Asian = A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. Black or African American = A person having origins in any of the black racial groups of Africa. Native Hawaiian or Other Pacific Islander = A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. White = A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

Data type

integer

Alias
UMLS CUI [1]
C0034510
Zip code
Description

First 5 digits of the ZIP code of the member's most recent primary residence.

Data type

integer

Alias
UMLS CUI [1]
C0421454
Zip Date
Description

Earliest date that the ZIP code is believed to be valid. Date will be updated/overwritten as ZIP code changes over time.

Data type

date

Alias
UMLS CUI [1]
C0421454
UMLS CUI [2,1]
C1519941
UMLS CUI [2,2]
C0011008
Back to the top of the page

Similar models

Sentinel Common Data Model Demographic

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demographic
C1704791 (UMLS CUI-1)
Patient ID
Item
text
C2348585 (UMLS CUI [1])
Patient Date of Birth
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
"A"mbiguous (e.g., transgender/hermaphrodite) (1)
CL Item
"F"emale (2 )
CL Item
"M"ale (3 )
CL Item
"U"nknown (4 )
Item
Hispanic?
integer
C0086409 (UMLS CUI [1])
Hispanic
Code List
Hispanic?
CL Item
"Y"es (1 )
CL Item
"N"o (2 )
CL Item
"U"nknown (3 )
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Unknown (0 )
CL Item
American Indian or Alaska Native (1 )
CL Item
Asian (2 )
CL Item
Black or African American (3 )
CL Item
Native Hawaiian or Other Pacific Islander (4 )
CL Item
White (5 )
Zip Code
Item
Zip code
integer
C0421454 (UMLS CUI [1])
Zip Code Valid Date
Item
Zip Date
date
C0421454 (UMLS CUI [1])
C1519941 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial