ID

37954

Description

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 Demographic Table contains one record per PatID with the most recent information on birth date, sex, race/ethnicity, and ZIP code.

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 -
Copyright Holder

FDA's Sentinel Initiative

Uploaded on

September 2, 2019

DOI

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License

Creative Commons BY-NC-ND 3.0
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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

text

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

text

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 [1,1]
C0421454
UMLS CUI [1,2]
C1519941
UMLS CUI [1,3]
C0011008
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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)
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Birth_Date
Item
Birth Date
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Ambiguous (e.g., transgender/hermaphrodite) (A)
CL Item
Female (F)
CL Item
Male (M)
CL Item
Unknown (U)
Item
Hispanic?
text
C0086409 (UMLS CUI [1])
Hispanic
Code List
Hispanic?
CL Item
No (N)
CL Item
Unknown  (U)
CL Item
Yes (Y)
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
Item
Zip code
integer
C0421454 (UMLS CUI [1])
Zip_Date
Item
Zip Date
date
C0421454 (UMLS CUI [1,1])
C1519941 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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