U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Forms & Submission Requirements
  5. Electronic Regulatory Submission and Review
  6. Data Standards Manual (monographs)
  7. Data Standards Manual (monographs): Race
  1. Data Standards Manual (monographs)

Data Standards Manual (monographs): Race

FDA Data Element Number.

CDER Data Element Number. C-GEN-10210

Data Element Name. Race.

Description. An ethnic stock or division of mankind.

Source. ASTM/E1384, and Dorland's Illustrated Medical Dictionary, 24th Edition

Relationship. Ethnic Origin.

FDA Specifications. Ethnic Origin shall consist of an alphanumeric term of indefinite length. There are no codes associated with these terms.

CDER Specifications. No further specifications.

FDA Approved Date. Pending Approval as an FDA Demographics Data Element.

CDER Approved Date. September 12, 1995; November 8, 1996.

FDA Revised Date.

CDER Revised Date.

Data Values. 

NAMEDEFINITIONFDA CODE
American Indian-Alaska NativeLiteralA
AsianLiteralB
WhiteLiteralC
BlackLiteralD
OtherLiteralE