Demographics

[Study Name/ID pre-filled] Site Name:

Subject ID:
1. Birth date*:
2. Birth time:
3. Age (years):
If less than 3 years of age (in months):
4. Gender* (Choose one):
Male Unspecified
Female Not reported
Unknown
5. Genotypic sex (Choose one):
6. XX
7. XY
8. XXX
9. XXY
10. XYY
11. Unspecified
12. Unknown
13. Other, specify
14. Ethnicity* (Choose one):
15. Hispanic or Latino 17. Unknown
16. Not Hispanic or Latino 18. Not Reported
19. Race Category* (Choose all that apply):
20. American Indian or Alaska Native 24. White
21. Asian 25. Unknown
22. Black or African-American 26. Not reported
23. Native Hawaiian or Other Pacific Islander 27.
28. Race (Choose all that apply):
29. Black African American
30. Black African
31. Black Afro Caribbean
32. South/Central American Indian
33. North American Indian
34. Alaskan Native
35. Inuit
36. South Asian
37. Far Eastern Asian
38. Western Asian
39. White North American
40. White South American
41. White European
42. White Middle Eastern
43. White African
44. White Australian
45. Hawaiian
46. Pacific Islander
47. Not reported
48. Other
49. Unknown
50. Primary language (ISO 639-2 code)

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 Demographics
[Study Name/ID pre-filled] Site Name:
Subject ID:
51. English (eng) 55. French (fre)
52. Spanish (spa) 56. German (ger)
53. Sign Languages (sgn) 57. Other, specify ISO 639-2 code:
54. Chinese languages (chi)
58. Language spoken fluently (ISO 639-2 code)
English (eng)
Spanish (spa)
Sign Languages (sgn)
Chinese languages (chi)
French (fre)
German (ger)
Other, specify ISO 639-2 code:
59. Language written fluently (ISO 639-2 code)
English (eng)
Spanish (spa)
Chinese languages (chi)
French (fre)
German (ger)
Other, specify ISO 639-2 code:
60. Birth country name (ISO 3166 1 alpha 2 code):
61. Hand preference type Left hand Right hand Both hands Unknown

TBI CDE Version 7.0 Page 2 of 3

SPECIFIC INSTRUCTIONS
Gender type Self-reported gender of the participant/subject. Gender is the socially constructed identity of
sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined
genetically.
o Unspecified is defined as Undifferentiated/Indeterminant/Intersex
Date of birth Record the date of birth to the level of precision known (e.g., month/day/year, year,
month/year, etc). The preferred format for recording date is MM/DD/YYYY. 99/99/9999 can be used to
indicate an unknown date.
Ethnicity Choose only one with which the participant/ subject most closely identifies.
Race category Choose all that apply.
Race Choose all that apply. Response is obtained by report of the participant/subject or caretaker.
Collecting information on race may not be allowed in some countries for concerns related to discrimination.
In other countries, however, these concerns are considered a reason for recording race in order to
guarantee equal access to care. Investigators receiving funding from the US National Institutes of Health
(NIH) are required to report the number of subjects enrolled on an annual basis using the racial categories
listed.
Birth country Choose one. It may be easier to record the full name of the country and code the data later
using the ISO 3166-1 alpha-2 codes.

*Element is classified as Core