CDE Detailed Report

Disease: Traumatic Brain Injury
Sub-Domain: 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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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

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

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

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

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

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

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

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
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

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
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

Free-Form Entry

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

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
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

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

Free-Form Entry

C18614 Education primary caregiver year count EduPrimCaregiverYrCt Number of years of education of the primary caregiver (age 5 and beyond) Number of years of education of the primary caregiver (age 5 and beyond How many years of education does the parent, guardian, or caregiver have? Numeric Values

In order to apply to international setting, this data element was made to supplement C00013

Adult;Pediatric Supplemental 3.00 2013-10-07 00:00:00.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

0 30 year
C21816 Sport elementary school other participation text ElementarySchoolSportOthrPlayd The free-text field to specify which other sports the participant/subject played in elementary school The free-text field to specify which other sports the participant/subject played in elementary school Which other sports did the subject play in elementary school? Alphanumeric

The free-text field to specify which other sports the participant played in elementary school

Adult;Pediatric Supplemental 1.00 2016-06-03 11:59:33.0 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

C22698 Parent occupation primary status ParentOccupationPrimaryStatus The status indicating the participant's/subject's parent, guardian, or caregiver's current primary occupational status The status indicating the participant's/subject's parent, guardian, or caregiver's current primary occupational statu What is the parent's, guardian's, or caregiver'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

C19287 Income basic needs status IncomeBasicNeedsStatus The status of how the household currently manages to meet basic needs as defined by food, shelter and clothing The status of how the household currently manages to meet basic needs as defined by food, shelter and clothin Does the subject's income meet the subject's household's basic needs? Very well;Very poorly;Unknown;Refused to answer;Rather well;Rather poorly;Adequately (neither well nor poorly) Very well;Very poorly;Unknown;Refused to answer;Rather well;Rather poorly;Adequately (neither well nor poorly) Alphanumeric Adult Supplemental 1.00 2014-06-06 11:03:24.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21977 Sport high school other participation total year count SportHighSchoolOtherYrsCt Total combined number of years participant/subject played other sport(s) in high school Total combined number of years participant/subject played other sport(s) in high school How many total combined years did the subject play other sports in high school? Numeric Values Adult;Pediatric Supplemental 1.00 2016-06-06 18:12:55.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

0
C00207 Marital or partner status MartlPartnerStatus Status of participant/subject's current domestic relationship, whether marital or partnered Status of participant/subject's current domestic relationship, whether marital or partnered What is the subject's marital status? Never married;Married;Domestic partnership;Divorced;Separated;Widowed Never married;Married;Domestic partnership;Divorced;Separated;Widowed Alphanumeric

STROKE: Johnson NJ, Backlund E, Sorlie PD, Loveless CA. Marital status and mortality: the national longitudinal mortality study. Ann Epidemiol. 2000;10:224-238. NCI CDE Browser Public ID = 2188083

Johnson NJ, Backlund E, Sorlie PD, Loveless CA. Marital status and mortality: the national longitudinal mortality study. Ann Epidemiol. 2000;10: 224-238. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2188083
C14123 Country of residence name CntryResdnceName Country where the participant/subject currently lives Country where the participant/subject currently live What is the subject's current country of residence name? Alphanumeric

This CDE should be used in combination with Country of residence ISO code CDE when there is no ISO code available for the country name. 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.

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

Free-Form Entry

C21805 Caregiver primary extended type CaregvPrimryExtendType Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject What is the relationship between the person who acts as the primary caregiver for the subject and the subject? Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify Alphanumeric

Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject

Adult;Pediatric Supplemental 1.00 2016-06-03 11:18:55.0 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C21988 Sport recreational other participation year count SportRecreationlOtherYrsCt Total number of years participant/subject played other sport(s) recreationally Total number of years participant/subject played other sport(s) recreationally How many total combined years did the subject play other recreational sports? Numeric Values Adult;Pediatric Supplemental 1.00 2016-06-06 18:34:23.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

0
C18658 Employment expanded status EmplmtExpndStatus Status of participant/subject's current employment (expanded list) Status of participant/subject's current employment (expanded list) What is the status of the subject's current employment? Working full time;Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment;Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce;Unable to obtain information;Unknown Working full time (35 hrs or more/week, at least minimum wage);Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment (sheltered workshop, supportive employment, job coach);Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce (including child, retired, student, homemaker, disabled pre-injury);Unable to obtain information;Unknown Alphanumeric

Prior TBI studies utilized the Employment Status data element for data capture

Choose one.

National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm) Adult;Pediatric Supplemental 1.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21817 Sport elementary school other participation total year count ElemntrySchoolSportOtherYrsCt Total combined number of years the participant/subject played other sport(s) in elementary school Total combined number of years the participant/subject played other sport(s) in elementary school What are the total combined years the subject played the other sports in elementary school? Numeric Values

Total combined number of years the participant played other sport(s) in elementary school

Adult;Pediatric Supplemental 1.00 2016-06-03 12:00:40.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

0 100
C00026 Language spoken Fluent text LangSpokeFluentTxt Text for each language that the participant/subject speaks fluently Text for each language that the participant/subject speaks fluently Please list each language the subject can speak fluently: Alphanumeric

Text for all languages participant/subject speaks fluently. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes.

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 255

Free-Form Entry

C22688 Parent Race USA Category ParentRaceUSACat The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categorie What is the parent, guardian, or caregiver's race, based on the OBM race standards? American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;White;Unknown;Not Reported A person having origins in any of the original peoples of North and South America (including Central America) , and who maintains tribal affiliation or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.;A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" can be used in addition to "Black or African American.";A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.;Could not be determined or unsure;Not provided or unavailable Alphanumeric

The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories.

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.

Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
C22699 Parent employment expanded status ParentEmplmtExpndStatus Status of the participant's/subject's parent, guardian, or caregiver's current employment Status of the participant's/subject's parent, guardian, or caregiver's current employment What is the status of the parent's, guardian's, or caregiver's current employment? Working full time;Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment;Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce;Unable to obtain information;Unknown Working full time (35 hrs or more/week, at least minimum wage);Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment (sheltered workshop, supportive employment, job coach);Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce (including child, retired, student, homemaker, disabled pre-injury);Unable to obtain information;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21114 Visit post baseline day count VisitPostBaselineDayCt The number of days since baseline visit The number of days since baseline visi The number of days since baseline Numeric Values

Enter the number of days passed since the baseline visit

Adult;Pediatric Supplemental 1.00 2015-06-12 14:49:48.0 FITBIR Demographics Form Demographics Participant Characteristics

Free-Form Entry

day
C21978 Sport college participation indicator SportCollegePartInd Indicator whether the participant/subject played sports in college Indicator whether the participant/subject played sports in colleg Did the subject participate in sports in college? Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult Supplemental 1.00 2016-06-06 18:13:59.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00208 Military USA service branch type MilUSAServBrnchTyp Branch of service in the U.S. military, not including the Commissioned Corps Branch of service in the U.S. military, not including the Commissioned Corps Which branch of service in the U.S. Military is the subject involved? Air force;Army;Marine Corps;Navy;Coast Guard;Other, specify;Air Force Reserve;Army Reserve;Coast Guard Reserves;Navy Reserves;Marine Corps Reserves;Air National Guard;Army National Guard Air force;Army;Marine Corps;Navy;Coast Guard;Other, specify;Air Force Reserve;Army Reserve;Coast Guard Reserves;Navy Reserves;Marine Corps Reserves;Air National Guard;Army National Guard Alphanumeric

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

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

Single Pre-Defined Value Selected

C15983 Education type EduTyp The type of education the participant/subject received The type of education the participant/subject receive What type of education did the subject receive? Public;Private;Home school;Other, specify Public;Private;Home school;Other, specify Alphanumeric

Choose all that apply

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

Multiple Pre-Defined Values Selected

C21806 Parent alive status ParentAliveStatus Specifies whether the participant's/subjects parents are still living Specifies whether the participant's/subjects parents are still living What are the living statuses of the subject's parents? Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown Alphanumeric

Specifies whether the participant's/subjects parents are still living

Answer for both parents

Adult;Pediatric Supplemental 1.00 2016-06-03 11:20:14.0 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00004 Birth country ISO code BirthCntryISOCode Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born What is the subject's birth country (use ISO code)? AU;CA;MX;GB;US AUSTRALIA;CANADA;MEXICO;UNITED KINGDOM;UNITED STATES 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 2013-07-24 21:00:23.88 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21989 Sport professional participation indicator SportProfessionlPartInd Indicator whether the participant/subject played sports professionally Indicator whether the participant/subject played sports professionall Did the subject participate in professional sports? Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult Supplemental 1.00 2016-06-06 18:35:21.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C18676 Employment expanded other text EmplmtExpndOTH The free-text field related to 'Employment expanded status' specifying other text. Status of participant/subject's current employment The free-text field related to 'Employment expanded status' specifying other text. Status of participant/subject's current employment Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C21818 Sport junior high participation indicator JuniorHighSchoolSportInd The indicator related to whether participant/subject played sports in junior high school The indicator related to whether participant/subject played sports in junior high school Did the subject participate in sports in junior high school? No;Yes No;Yes Alphanumeric

The indicator related to whether subject played sports in junior high school

Adult;Pediatric Supplemental 1.00 2016-06-03 12:46:21.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

CSV