CDER DATA STANDARDS MANUAL

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

Relationship.

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.

Data Values.

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