Cerebral Palsy Research Network Blog

_NINDS CDE


Field Value
CDE ID C00020
CDE Name Ethnicity USA category
Variable Name EthnUSACat
Definition

Category of ethnicity the participant/subject most closely identifies with

Description

A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term “Spanish origin” can also be used in addition to “Hispanic or Latino.”;A person not meeting the definition for Hispanic or Latino.;Could not be determined or unsure;Not reported;Other, specify;

Instructions

Choose one. Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be “collapsible” up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list.

Input Restrictions Single Pre-Defined Value Selected
Permissible Values

Hispanic or Latino;Not Hispanic or Latino;Unknown;Not reported;Other, specify;

Question Text Ethnicity
Data Type Alphanumeric
Population Adult, Pediatric
Measurement Type
Field Size
Minimum Value
Maximum Value
Domain Participant Characteristics
SubDomain Demographics
CRF Module Demographics
Alias ETHN_GRP_CAT_TXT
Classification Core
Copyright/Trademark
Previous Title Ethnicity USA category
References

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 – http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm)

CA DSR ID 2192217
CDISC ID
LOINC ID
SNOMED
Version Date 2013-08-28T16:08:00.453
Version Number 3