FDA Data Element Number.
CDER Data Element Number. C-GEN-10209
Data Element Name. Gender
Description. Gender refers to the sex of a species.
Source. ISO 5218, and Webster's New Collegiate Dictionary
FDA Specifications. Gender shall consist of alphabetic terms with a maximum of 15 characters in length. Codes representing these terms shall consist of one numeral.
CDER Specifications. No further specifications.
FDA Approved Date. This data element is pending approval as an FDA Demographics Data Element.
CDER Approved Date. September 12, 1995.
FDA Revised Date.
CDER Revised Date.