CDE Detailed Report

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

Displaying 51 - 100 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
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

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
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
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

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
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

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
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

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

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

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

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

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

C00027 Language written Fluent text LangWrtnFlntlyTxt Text for each language that the participant/subject writes fluently Text for each language that the participant/subject writes fluently Please list each language the subject can write fluently: Alphanumeric

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

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

C22689 Parent race expanded category ParentRaceCat Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with What is the parent/guardian, or caregiver's race, using expanded race categories? Not reported;Other;Unknown;Black African American;Black African;Black Afro Caribbean;South/Central American Indian;North American Indian;Alaskan Native;Inuit;South Asian;Far Eastern Asian;Western Asian;White North American;White South American;White European;White Middle Eastern;White African;White Australian;Hawaiian;Pacific Islander;American Indian or Alaska Native;Caucasian;Asian-West;Asian-East;African-North Not reported;Other;Unknown;Black African American (for OMB purposes, this value is considered to be part of Black or African-American);Black African (for OMB purposes, this value is considered to be part of Black or African-American);Black Afro Caribbean (for OMB purposes, this value is considered to be part of Black or African-American);South/Central American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);North American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Alaskan Native (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Inuit (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);Far Eastern Asian (e.g., China, Japan, Korea, etc.) (for OMB purposes, this value is considered to be part of Asian);Western Asian (e.g., Pakistan, Iraq, Iran) (for OMB purposes, this value is considered to be part of Asian);White North American (for OMB purposes, this value is considered to be part of White);White South American (for OMB purposes, this value is considered to be part of White);White European (for OMB purposes, this value is considered to be part of White);White Middle Eastern (for OMB purposes, this value is considered to be part of White);White African (for OMB purposes, this value is considered to be part of White);White Australian (for OMB purposes, this value is considered to be part of White);Hawaiian (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);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.;Caucasian;Asian-West;Asian-East;African-North Alphanumeric

Category of race(s) or region(s) the parent, guardian, or caregiver most closely identifies with

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 subject's enrolled on an annual basis using the racial categories listed.

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

Multiple Pre-Defined Values 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

C21759 Primary other person shared living adult patient text SesPrimAdultOTH Primary person living with adult patient Primary person living with adult patient Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-02 13:29:06.0 FITBIR Demographics Form Demographics Participant Characteristics 256

Free-Form Entry

C21979 Sport college primary participation type SportCollegePrimaryPartTyp The primary sport the participant/subject played in college The primary sport the participant/subject played in colleg What was the primary sport the subject played in college? Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing Alphanumeric Adult Supplemental 1.00 2016-06-06 18:24:16.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00214 Living with persons count PrsnCohabitCt Count of other people with whom the participant/subject currently lives, cohabits, or stays Count of other people with whom the participant/subject currently lives, cohabits, or stays What is the count of other people with whom the subject currently lives, cohabits, or stays? Numeric Values

Include everyone who is living or staying here for more than 2 months. Include participant/subject if they are living here for more than 2 months. Include anyone else staying here who does not have another place to stay even if they are here for 2 months or less. Do not include anyone who is living somewhere else for more than 2 months, such as college student living away or someone in the Armed Forces on deployment. Answer should be recorded as a 2 digit number (i.e., one should be recorded as 01, ten should be recorded as 10). Participant/subject should NOT be included.

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

0 99
C22700 Parent job classification category ParentJobclassCat Category that classifies work performed by the participant's/subject's parent, guardian, or caregiver Category that classifies work performed by the participant's/subject's parent, guardian, or caregive What is the parent, guardian, or caregiver's 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;Professional referral;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;Professional referral;Service or sales worker;Technicians and associate professionals (typically requiring a Bachelor degree or equivilent);Not applicable;Unknown;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21807 Military occupational status MilMOS Military occupational status of participant/subject Military occupational status of participant/subject What is the military occupational status of the subject? Non-combat;Combat;Other, specify Non-combat;Combat;Other, specify Alphanumeric

Military occupational status of participant

Adult;Pediatric Supplemental 1.00 2016-06-03 11:21:24.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00005 Birth country name BirthCntryName Name for country where the participant/subject was born Name for country where the participant/subject was born What is the subject's birth country name? Alphanumeric

Text for participant/subject's birth country. It may be easier to record the full name of the country and code the data later in Birth country ISO code using the ISO 3166-1 alpha-2 codes.

Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 FITBIR Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C21990 Sport professional primary participation type SportProfessionlPrimryPlaydTyp The primary sport the participant/subject played professionally The primary sport the participant/subject played professionall What was the primary professional sport the subject played? Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing Alphanumeric Adult Supplemental 1.00 2016-06-06 18:36:16.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C15989 Unemployed reason UnemplymntRsn Participant's/subject's reason for unemployment Participant's/subject's reason for unemployment What is the subject's reason for being unemployed? Alphanumeric

Specify the reason for unemployment

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C21819 Sport junior high primary participation text JuniorHighPrimrySportPlayedTxt The indicator related to which sports participant/subject played in junior high school The indicator related to which sports participant/subject played in junior high school What was the primary sport the subject played in junior high school? Alphanumeric

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

Adult;Pediatric Supplemental 1.00 2016-06-03 12:47:49.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00028 Language spoken fluent ISO code LangSpokeFluentISOCode Code (ISO 639-2)for each language that the participant/subject speaks fluently Code (ISO 639-2)for each language that the participant/subject speaks fluently What are the ISO codes for each language the subject can speak fluently? The ISO codes represent the international codes for different countries. English (eng);German (ger);Other specify;Chinese languages (Chi);fre;sgn;Spanish (spa) English (eng);German (ger);Other specify;Chinese languages (Chi);French;Sign Languages;Spanish (spa) Alphanumeric

Choose all that apply. 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

Multiple Pre-Defined Values Selected

C22690 Parent Ethnicity USA category ParentEthnUSACat Category of ethnicity the parent, guardian, or caregiver most closely identifies with Category of ethnicity the parent, guardian, or caregiver most closely identifies with What is the parent's, guardian's, or caregiver's ethnicity? 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

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.

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

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

Single Pre-Defined Value Selected

2192217
C18739 Military USA service branch other text MilUSAServBrnchOTH The free-text field related to 'Military USA service branch type' specifying other text. Branch of service in the U.S. military, not including the Commissioned Corps The free-text field related to 'Military USA service branch type' specifying other text. Branch of service in the U.S. military, not including the Commissioned Corps 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

C21794 Living situation juvenile patient type SesPrimChild Living situation of juvenile patient Living situation of juvenile patient What is the subject's living situation? Adoptive parents;Foster care;Other family member;Parent;Unable to obtain information;Other, specify Adoptive parents;Foster care;Other family member;Parent;Unable to obtain information;Other, specify Alphanumeric

Living situation of juvenile patient

Adult;Pediatric Supplemental 1.00 2016-06-02 15:03:52.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21980 Sport college participation total year count SportCollegePrimaryYrsCt Total combined years the participant/subject played primary college sport (should be used in combination with Primary college sport played by the participant UDE) Total combined years the participant/subject played primary college sport (should be used in combination with Primary college sport played by the participant UDE How many years did the subject play the primary sport in college? Numeric Values Adult Supplemental 1.00 2016-06-06 18:25:34.0 FITBIR Demographics Form Demographics Participant Characteristics

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C00220 Military USA rank category MilUSARnkCat Category that describes the participant's/subject's rank in the military Category that describes the participant's/subject's rank in the military What is the subject's military rank? Company grade officer;Warrant officer;Non-commissioned officer;Other enlisted rank;Field grade officer or above Company grade officer;Warrant officer;Non-commissioned officer (e.g., sergeant/corporal);Other enlisted rank;Field grade officer or above Alphanumeric

Choose one. Response is obtained by report of the participant/subject or relatives. NATO rank specifications could be used instead, but military personnel are typically unfamiliar with these ranks (i.e., they do not know their own NATO rank specification). Ranks generally reflect level of responsibility and type of activities engaged in while in theatre - information that may correlate with risk/severity/type of injury.
If Active, Active reserves Inactive or Civilian Military Contractor, specify. Military service status.

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

Single Pre-Defined Value Selected

C22701 Parent unemployed reason ParentUnemplymntRsn Participant's/subject's parent, guardian, or caregiver's reason for unemployment Participant's/subject's parent, guardian, or caregiver's reason for unemployment What is the parent, guardian, or caregiver's reason for being unemployed? Alphanumeric

Specify the reason for unemployment

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics 255

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C21808 Military occupational status other text MilMOSOTH Military occupational status of participant/subject other text Military occupational status of participant/subject other text Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 11:23:15.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C00007 Birth date BirthDate Date (and time, if applicable and known) the participant/subject was born Date (and time, if applicable and known) the participant/subject was born What is the subject's date of birth? 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.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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.

ISO 8601 - http: //www.iso.org/iso/iso_catalogue.htm Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17: 573-581.<br />Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2): 259-69. <br />Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatric 116: 1374-1382 Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

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C21991 Sport professional participation total year count SportProfessPrimPartTtlYrsCt Total combined years the participant/subject played primary professional sport (should be used in combination with Primary professional sport played by the participant/subject CDE) Total combined years the participant/subject played primary professional sport (should be used in combination with Primary professional sport played by the participant/subject CDE) What is the total number of years the subject played the primary professional sports? Numeric Values

Use in combination with Primary professional sport played by the participant UDE.

Adult Supplemental 1.00 2016-06-06 18:37:01.0 FITBIR Demographics Form Demographics Participant Characteristics

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C15993 Dependent children number DpndntChildNum Number of dependent children Number of dependent children What is the total number of dependents children the subject has? Numeric Values

Number of dependent children for a participant/subject

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

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C21820 Sport junior high participation year count JuniorHighPrimarySprtYrsCt The number of years participant/subject played sport(s) in junior high school The number of years participant/subject played sport(s) in junior high school How many years did the subject play the primary sport in junior high school? 1;2;3;4;5;6 1;2;3;4;5;6 Numeric Values

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

Adult;Pediatric Supplemental 1.00 2016-06-03 12:48:46.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00029 Language written fluent ISO code LangWrtnFlntlyTxtISOCode Code (ISO 639-2) for each language that the participant/subject writes fluently Code (ISO 639-2) for each language that the participant/subject writes fluently What are the ISO codes for each language the subject can write fluently? Alphanumeric

Enter all that apply

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

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C22691 Parent birth country ISO code ParentBirthCntryISOCode Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was born Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was bor What is the parent's, guardian's, or caregiver's birth country ISO code? AU;CA;MX;GB;US AUSTRALIA;CANADA;MEXICO;UNITED KINGDOM;UNITED STATES Alphanumeric

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.

Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born

Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C18747 Residence other text ResdncOTH The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C21798 Living situation juvenile patient other text SesPrimChildOTH Living situation of juvenile patient other text Living situation of juvenile patient other text Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 08:49:58.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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CSV