CDE Detailed Report

Disease: Traumatic Brain Injury
Subdomain Name: Demographics
CRF: FITBIR Demographics Form

Displaying 1 - 50 of 123
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C21983 Sport college other participation total year count SportCollegeOtherYrsCt Total combined years the participant/subject played other college sport(s) (should be used in combination with Other sport(s) the participant played in college) Total combined years the participant/subject played other college sport(s) (should be used in combination with Other sport(s) the participant played in college How many total combined years did the subject play other sports in college? Numeric Values

Use in combination with Other sport(s) the participant played in college UDE

Adult Supplemental 1.00 2016-06-06 18:29:02.0 FITBIR Demographics Form Demographics Participant Characteristics

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C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form Who is the source of this information in relation to the subject? Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Alphanumeric

Choose all that apply

Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C22708 Parent ethnicity USA category other text ParentEthnUSACatOTH The free-text field describing the category of ethnicity the participant's/subject's parent/guardian most closely identifies with The free-text field describing the category of ethnicity the participant's/subject's parent/guardian most closely identifies wit Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-08-22 11:45:27.0 FITBIR Demographics Form Demographics Participant Characteristics 255

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C21800 Living situation before injury other text LivingSituationPreInjTypOTH Living situation of the participant/subject before injury other text Living situation of the participant/subject before injury other tex Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 10:38:50.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00013 Education level primary caregiver USA type EduLvlPrimCaregiverUSATyp Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received What is the parent's, guardian's, or caregiver's highest grade or level of school completed? Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Alphanumeric

Choose the highest level attained by the participant/subject's primary caregiver. This element is recommended for Pediatric stroke studies. Choose highest level attained.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21994 Sport professional participation other total year count SportProfessionPartOthTtlYrsCt Total combined years the participant/subject played other professional sport(s) (should be used in combination with Other professional sports played by the participant/subject Total combined years the participant/subject played other professional sport(s) (should be used in combination with Other professional sports played by the participant/subjec What is the total number of years the subject played other professional sports? Numeric Values

Use in combination with Other professional sports played by the participant UDE

Adult Supplemental 1.00 2016-06-06 18:40:17.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

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C17396 Sex genotype type SexGenotypTyp The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement Sex chromosomes of the participant/subject based upon genotyping What is the subject's sex or genotype? XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex Alphanumeric

Choose only one

Added to TBI per meeting with FITBIR on 12/18/13.

Adult;Pediatric Core 3.10 2018-07-26 00:00:00.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21812 Sport head neck injury indicator TBISportInd The indicator related to having a injury of head or neck in sports The indicator related to having a injury of head or neck in sport Was the subject's traumatic brain injury sports related? Yes;No;Unknown Yes;No;Unknown Alphanumeric

The indicator related to having a injury of head or neck in sports.

Adult;Pediatric Supplemental 1.00 2016-06-03 11:54:50.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00035 Gender type GenderTyp Self-reported gender of the participant/subject Self-reported gender of the participant/subjec What is the subject's gender? Alphanumeric

Choose one. Response is obtained by report of the participant/subject or caretaker.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm)

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http: //grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
C22694 Parent dependent children liviing in household number ParentDpndntChildLvngHshldNum Number of dependent children living in parent's, guardian's or caregiver's household Number of dependent children living in parent's, guardian's or caregiver's household What is the number of dependent children living in the parent, guardian, or caregiver's household? Numeric Values

Refer to Household and Income.

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

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C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject ID Number Alphanumeric

The participant or subject identifiers or IDs should be assigned by the study.

SCI Variable: SUBJECT

Alexander MS, Biering-Saarensen F, Elliott S, Kreuter M, Saanksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Alexander MS, Biering-S&Oslash;rensen F, Elliott S, Kreuter M, S&Oslash;nksen J. International spinal cord injury male sexual function basic data set. Spinal Cord. 2011 Jul;49(7):795-8.<br />Bauman WA, Biering-Saarensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.<br />Biering-Saarensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30.<br />Krogh K, Perkash I, Stiens SA, Biering-Saarensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41.<br />Widerstraam-Noga E, Biering-Saarensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 FITBIR Demographics Form Demographics Participant Characteristics 255

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C21973 Sport high school participation indicator SportHighSchoolInd Whether participant/subject played sports in high school Whether participant/subject played sports in high school Did the subject participate in sports in high school? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:07:34.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21984 Sport recreational participation indicator SportRecreationlPartInd Whether the participant/subject played recreational sports Whether the participant/subject played recreational sports Did the subject participate in recreational sports? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:30:14.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C10467 Risk Factor Questionnaire (RFQ) - military service current active status RFQMilSrvcCurrActStatus The status whether the participant/subject is currently active in the military as part of the Risk Factor Questionnaire (RFQ) - Occupation The status whether the participant/subject is currently active in the military as part of the Risk Factor Questionnaire (RFQ) - Occupatio Is the subject active military? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Whether participant currently has active military status

Adult;Pediatric Supplemental 3.00 2013-07-18 09:11:50.26 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21801 Education highest level before injury type HighestLvlEduPreInj Highest level education pre-injury Highest level education pre-injury What is the highest level of education the subject received pre-injury? None/basic primary = 0 - 4 years;Primary/Intermediate Primary = 5 - 8 years;Secondary = 12 years;Tertiary = 13 - 15 years (e.g., Teachers, Technicians);University = 16 - 17 years;Post Graduate = 18-19 years (e.g., Masters, Doctoral);Unknown None/basic primary = 0 - 4 years;Primary/Intermediate Primary = 5 - 8 years;Secondary = 12 years;Tertiary = 13 - 15 years (e.g., Teachers, Technicians);University = 16 - 17 years;Post Graduate = 18-19 years (e.g., Masters, Doctoral);Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 10:54:09.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00015 Education year count EduYrCt Number of years of education completed (age 5 and beyond) Number of years of education completed (age 5 and beyond) How many years of education does the subject have? Numeric Values

Choose the highest level attained by the participant/subject caBIG CDE Public ID = 3134878 For years completed, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI.

Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 FITBIR Demographics Form Demographics Participant Characteristics

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0 30 year 3134878
C22682 Case Control Indicator CaseContrlInd The response related to whether subject is in the case or control arm of the study Indicator of whether subject is in the case or control arm of the study Is the subject in the case or control arm of the study? Case;Control;Unknown Case;Control;Unknown Alphanumeric

Indicate whether subject is (was) in the case or control arm of the study

Adult;Pediatric Supplemental 1.00 2016-07-27 13:36:42.0 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C17399 Global unique identifier number GlobalUniqueIdNum Global Unique ID (GUID) which uniquely identifies a subject Global Unique ID which uniquely identifies a subject GUID Alphanumeric Johnson SB, Whitney G, McAuliffe M, Wang H, McCreedy E, Rozenblit L, Evans CC. Using global unique identifiers to link autism collections. J Am Med Inform Assoc. 2010;17(6):689-95. doi: 10.1136/jamia.2009.002063. Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 FITBIR Demographics Form Demographics Participant Characteristics 255

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C21813 Sport elementary school participation indicator ElementarySchoolSprtInd The indicator related to whether participant/subject participated in sport(s) in elementary school The indicator related to whether participant/subject participated in sport(s) in elementary school Did the subject participate in sports in elementary school? No;Yes No;Yes Alphanumeric

The indicator related to whether subject participated in sport(s) in elementary school

Adult;Pediatric Supplemental 1.00 2016-06-03 11:56:15.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00202 Education school participation status EduSchoolParticipStatus Status of participant/subject's current attendance at school Status of participant/subject's current attendance at school What is the subject's current attendance in school? Going to school;On vacation from school (between grades);Neither;Unknown Going to school;On vacation from school (between grades);Neither;Unknown Alphanumeric National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22695 Parent dependent children number ParentDpndntChildNum Number of dependent children the participant's/subject's parent, guardian, or caregiver has Number of dependent children the participant's/subject's parent, guardian, or caregiver has What is the total number of dependent children the parent, guardian, or caregiver's has? Include both living in the household and living elsewhere. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

C19257 Residence area type ResidenceAreaTyp Type describing the participant's/subject's current location of residence Type describing the participant's/subject's current location of residence How would you describe the subject's current location of residence? A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 17:27:45.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21974 Sport high school primary participation indicator SportHighSchoolPrimryPartInd The primary sport the participant/subject played in high school The primary sport the participant/subject played in high school What was the primary sport the subject played in high school? Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:09:32.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C21985 Sport recreational primary participation text SportRecreationlPrimryPlaydTxt Which sport the participant/subject primarily played recreationally Which sport the participant/subject primarily played recreationally What is the primary recreational sport played by the subject? Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:31:07.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C10676 Country of residence code CntryResdnceISOCode Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently live What is the subject's current country of residence? US;CA;GB;MX;AU;Other, specify USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify Alphanumeric

Choose only one country which the subject/participant currently lives. If the country code is not included on the form then code the data later using ISO 3166-1 alpha-2 codes. If ISO code does not exist, use Country of residence name CDE to write the country name.

Choose only one country which the subject/participant currently lives. If the country code is not included on the form, then code the data later using ISO 3166-1 alpha-2 codes. ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists)

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21802 Job classification before injury category JobClassPreInj Job classification pre-injury Job classification pre-injury What was the subject's pre-injury job classification? Agricultural or fishery worker;Armed forces occupation;Clerk;Craft and related trades workers;Elementary occupations;Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Service or sales worker;Technicians and associate professionals;Not applicable;Unknown;Other, specify Agricultural or fishery worker;Armed forces occupation (officers, service personnel);Clerk;Craft and related trades workers (e.g. motor mechanic, printer, tool and die makers, electrician);Elementary occupations (laborer, porter, unskilled workers);Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Service or sales worker;Technicians and associate professionals (typically requiring a Bachelor degree or equivilent);Not applicable;Unknown;Other, specify Alphanumeric

For detailed definitions go to: http://www.who.int/healthinfo/survey/whsshortversionguide.pdf

Adult;Pediatric Supplemental 1.00 2016-06-03 10:56:59.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00020 Ethnicity USA category EthnUSACat Category of ethnicity the participant/subject most closely identifies with Category of ethnicity the participant/subject most closely identifies with What is the subject's ethnic background? Hispanic or Latino;Not Hispanic or Latino;Unknown;Not reported;Other, specify 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 Alphanumeric

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and 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.

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)

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core 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) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
C22683 Context type ContextType The context to which the questions were answered, e.g., since the last interview or after the injury The context to which the questions were answered, e.g., since the last interview or after the injur Time frame related context (if any) to which the questions were answered After injury;At time of assessment;Before injury;Last 2 weeks;Last 6 months;Last 24 hours;Last month;Last week;Last year;Prior to death;Since last interview;Time of injury;Other, specify After injury;At time of assessment;Before injury;Last 2 weeks;Last 6 months;Last 24 hours;Last month;Last week;Last year;Prior to death;Since last interview;Time of injury;Other, specify Alphanumeric

This question should be the first required question in the repeatable group which contains time frame, context dependent questions.

Adult;Pediatric Supplemental 1.00 2016-07-29 10:50:39.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C17402 Site name SiteName The name of the site for the study The name of the site for the study Site Name Alphanumeric

Enter the name of the study site

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 FITBIR Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C21814 Sport elementary school primary participation text ElementarySchoolPrimaryPlayed The free-text field to specify the primary sport the participant/subject played in elementary school The free-text field to specify the primary sport the participant/subject played in elementary school What was the primary sport the subject played in elementary school? Alphanumeric

The free-text field to specify the primary sport the participant played in elementary school

Adult;Pediatric Supplemental 1.00 2016-06-03 11:57:17.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00205 Family income range FmlyIncRng Range, in U.S. dollars, of the annual pre-tax, pre-deduction total income, of the household of which the participant/subject is a member Range, in U.S. dollars, of the annual pre-tax, pre-deduction total income, of the household of which the participant/subject is a member What is the range, in U.S. dollars, of annual pre-tax, pre-deduction total income, of the subject household? $15,000 to $24,999;$25,000 to $34,999;$35,000 to $49,999;$50,000 to $74,999;$75,000 to $99,999;$100,000 and over;Refused;Unknown;Under $15,000 $15,000 to $24,999;$25,000 to $34,999;$35,000 to $49,999;$50,000 to $74,999;$75,000 to $99,999;$100,000 and over;Refused;Unknown;Under $15,000 Alphanumeric

Choose one. This includes pre-tax cash income earned by persons, money wages and salaries, self-employment income, property income (dividends, interest and rents), money transfer payments from a variety of government and private welfare and social insurance schemes (such as social security, unemployment and workers compensation, and public assistance), private and government retirement income, interpersonal transfers (such as alimony and child support) and other periodic income. This excludes certain lump sum payments and capital gains. Add date stamp for when assessed. Recommend collection at least on date of TBI and perhaps after all initial medical treatment.

American Community Survey questionnaire. U.S. Department of Commerce, U.S. Census Bureau. http://www.census.gov/acs/www/Downloads/questionnaires/2012/Quest12.pdf Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22696 Parent residence area type ParentResidenceAreaTyp Type describing the participant's/subject's parent, guardian, or caregiver's current location of residence Type describing the participant's/subject's parent, guardian, or caregiver's current location of residence How would you describe the parent, guardian, or caregiver's current location of residence? A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 17:27:45.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C19258 Occupation primary status OccupationPrimaryStatus The status indicating the participant's/subject's current primary occupational status The status indicating the participant's/subject's current primary occupational statu What is the subject's current primary occupational status? Homemaker;Other, specify;Paid work;Retired;Retired;Student;Unemployed;Unknown;Unpaid work Homemaker;Other, specify;Paid work (employed/self-employed, including military);Retired (disability pension);Retired (non-disability);Student (including on the job training);Unemployed (none of the above);Unknown;Unpaid work (volunteer) Alphanumeric Adult Supplemental 1.00 2014-06-06 08:50:45.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21975 Sport high school primary played count HighSchoolPrimarySportYrsCt Number of years participant/subject played sport(s) in high school Number of years participant/subject played sport(s) in high school How many years did the subject play the primary sport in high school? 1;2;3;4;5;6 1;2;3;4;5;6 Numeric Values Adult;Pediatric Supplemental 1.00 2016-06-06 18:10:36.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21986 Sport recreational participation total year count SportRecreationlPrimryYrsCt Total number of years the participant/subject played primary sport recreationally Total number of years the participant/subject played primary sport recreationally How many years did the subject play the primary recreational sport? Numeric Values Adult;Pediatric Supplemental 1.00 2016-06-06 18:32:23.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

0
C11086 School placement type SchoolPlacementTyp The description of the type of education the participant/subject receives with details of being with or without assistance The description of the type of education the participant/subject receives with details of being with or without assistanc What is the type of education the subject receives with details of being with or without assistance? Full-time regular education without aide;Full-time regular education with one to one aide;Regular education with pull-out for certain areas;Special education w/minimal inclusion (e.g., lunch);Full time special education with no inclusion;Special (MR/DD) school;Home-schooled;Not in school;Other, specify Full-time regular education without aide;Full-time regular education with one to one aide;Regular education with pull-out for certain areas;Special education w/minimal inclusion (e.g., lunch);Full time special education with no inclusion;Special (MR/DD) school;Home-schooled;Not in school;Other, specify Alphanumeric

This element can be collected to describe the participant/subject prior to the stroke event and also to assess the participant/subject at subsequent time points after the stroke event.

Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21803 Job classification before injury other text JobClassPreInjOTH The free-text field related to Job classification pre-injury specifying other text The free-text field related to Job classification pre-injury specifying other tex Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 10:58:31.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel What is the subject's handedness preference, or dominant hand? Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

The purpose of this element is to determine dominant hemisphere; therefore, for those who were originally left handed but forced to write right-handed, record left-handed.

Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively Choose the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed.

Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430-8. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2180147
C22684 Parent gender type ParentGenderTyp Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of a parent determined genetically Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of a parent determined geneticall What is the parent's, guardian's, or caregiver's gender? Female;Male;Unknown;Unspecified;Not reported Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported Alphanumeric

Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex.

Choose one. Response is obtained by report of the participant/subject or parent, guardian, or caretaker.

Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
C17409 Visit date VisitDate Date of interview or visit (actually the date when data in the form were captured) Date of interview or visit Visit Date Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.

21 CFR 50.20 General requirements for informed consent A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Contents (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm#general) Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

C21815 Sport elementary school participation year count ElementarPrimarySprtYrsNum The number of years participant/subject played sport(s) in elementary school The number of years participant/subject played sport(s) in elementary school How many years did the subject play the primary sport in elementary school? 1;2;3;4;5;6 1;2;3;4;5;6 Numeric Values

The number of years subject played sport(s) in elementary school

Adult;Pediatric Supplemental 1.00 2016-06-03 11:58:23.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00206 Family income supported persons count FamilyIncmeSupprtPersCt Count of all people, including the participant/subject, who are supported by the household gross annual income reported Count of all people, including the participant/subject, who are supported by the household gross annual income reported What is the number of people supported by the above income? Numeric Values

Add date stamp for when assessed. Recommend collection at least on date of TBI and perhaps after all initial medical treatment.

American Community Survey questionnaire. U.S. Department of Commerce, U.S. Census Bureau. http://www.census.gov/acs/www/Downloads/questionnaires/2012/Quest12.pdf Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

1 99
C22697 Parent residence type ParentResdncTyp Type of residence where the participant's/subject's parent, guardian, or caregiver is currently living Type of residence where the participant's/subject's parent, guardian, or caregiver is currently living What type of residence does the parent, guardian, or caregiver currently live? Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center Alphanumeric

Choose one. Add date and time stamp for when assessed.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C19259 Occupation primary other status text OccupationPrimaryOthrStatusTxt The free-text field to capture other status indicating the participant's/subject's current primary occupational status The free-text field to capture other status indicating the participant's/subject's current primary occupational statu Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-06 09:12:40.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C21976 Sport high school other participation text SportHighSchoolOtherPartTxt Which sports participant/subject played in high school Which sports participant/subject played in high school Which other sports did the subject play in high school? Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:12:02.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C21987 Sport recreational other participation text SportRecreationlOtherPlaydTxt Which other sport(s) the participant/subject played recreationally Which other sport(s) the participant played/subject recreationally Which other recreational sports did the subject play? Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:33:20.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C12605 Caregiver primary type CaregvrPrimryType Type of relationship that the person who serves as the participant/subject's primary caregiver has with the participant/subject Type of relationship that the person who serves as the participant/subject's primary caregiver has with ther participant/subject Who is the primary person living with the subject? Alone;Child;Group living situation, boarding house;Homeless;Military barracks;Other;Other patients (in hospital/nursing home);Other residents;Other, specify;Parent or legal guardian;Personal care attendant;Roommates/friends;Self;Sibling;Spouse or partner;Unable to obtain information Alone;Child;Group living situation, boarding house;Homeless;Military barracks;Other;Other patients (in hospital/nursing home);Other residents;Other, specify;Parent or legal guardian;Personal care attendant;Roommates/friends;Self;Sibling;Spouse or partner;Unable to obtain information Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C21804 Job classification current other text JobClassNowOTH The free-text field related to Job classification-now specifying other text The free-text field related to Job classification-now specifying other tex Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 11:17:16.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00025 Language primary text LangPrimryTxt Text for the language the participant/subject speaks most often Text for the language the participant/subject speaks most often What is the subject's primary language (use ISO code)? eng;spa;sgn;chi;fre;ger;Other, specify English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify Alphanumeric

Choose one. It may be easier to record the full name of the language using Language primary text and code the data later using the ISO 639-2 alpha-3 codes.

Data Sharing Instructions: The language data should be coded using the ISO 639-2 codes prior to aggregation or sharing.

ISO 639-2 language codes (http: //www.loc.gov/standards/iso639-2/php/code_list.php) Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22687 Marital or partner status other text MartlPartnerStatusOTH The free-text field related to Marital or partner status specifying other text. Status of participant/subjects current domestic relationships The free-text field related to Marital or partner status specifying other text. Status of participant/subjects current domestic relationship Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-08-01 13:44:07.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

CSV