CDE Detailed Report

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

Displaying 101 - 123 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
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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793
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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1 50
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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C21981 Sport college primary participation other text SportCollegePrimarPartOTH Other sports the participant/subject played in college. A complimentary CDE for Primary college sport played by the participant/subject Other sports the participant/subject played in college. A complimentary CDE for Primary college sport played by the participant/subjec Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:26:32.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C00222 Job classification category JobclassCat Category that classifies work performed by participant/subject Category that classifies work performed by participant/subjec What is the subject's current 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

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

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

Single Pre-Defined Value Selected

C22706 Military USA rank category other text MilUSARnkCatOTH The free-text field related to Military rank category specifying other text. Category that describes the participant's/subject's rank in the military The free-text field related to Military rank category specifying other text. Category that describes the participant's/subject's rank in the military Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-08-22 09:14:32.0 FITBIR Demographics Form Demographics Participant Characteristics 255

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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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C21809 Military deployment location MilDeploy Region or country to where participant/subject was deployed Region or country to where participant/subject was deployed Where was the subject deployed? Iraq;Afghanistan;Africa;Germany;None;Other, specify Iraq;Afghanistan;Africa;Germany;None;Other, specify Alphanumeric

Region or country the military patient was deployed

Adult;Pediatric Supplemental 1.00 2016-06-03 11:24:57.0 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00008 Age value AgeVal Value for participant's age, calculated as elapsed time since the birth of the participant Value for participant's age, calculated as elapsed time since the birth of the participant Subject's age (recorded in years) Numeric Values

The subject's age is typically recorded to the nearest full year completed, e.g., 11 years and 6 months should be recorded as 11 years. For subject's which are under 1 year old, use decimal points and use the following convention: record 1 month as 0.083 (1/12), 2 months as 0.166 (2/12), 3 months as 0.25 (3/12), 4 months as 0.333 (4/12), 5 months as 0.416 (5/12), 6 months as 0.5 (6/12), 7 months as 0.583 (7/12), 8 months as 0.666 (8/12), 9 months as 0.75 (9/12), 10 months as 0.833 (10/12), 11 months as 0.916 (11/12) and 12 months as 1 year.

Adult;Pediatric Supplemental 3.10 2024-02-29 15:47:28.0 FITBIR Demographics Form Demographics Participant Characteristics

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0 1800 month
C21992 Sport professional primary participation other text SportProfessionalPartOTH Other sports the participant played professionally. A complimentary element for Primary professional sport played by the participant Other sports the participant played professionally. A complimentary element for Primary professional sport played by the participan Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:38:26.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C15994 Dependent children living in household number DpndntChildLvngHshldNum Number of dependent children living in household Number of dependent children living in household What is the number of dependent children living in the subject's household? Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

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C21821 Sport junior high other participation text JuniorHighSportOtherplayedTxt The free-text field to specify which other sports participant/subject played in junior high school The free-text field to specify which other sports participant/subject played in junior high school Which other sports did the subject play in junior high school? Alphanumeric

The free-text field to specify which other sports subject played in junior high school

Adult;Pediatric Supplemental 1.00 2016-06-03 12:51:28.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C00030 Race USA category RaceUSACat The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories The patient's self declared racial origination, independent of ethnic origination, using OMB approved categori What is the subject's racial background (as defined by OMB)? 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

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.

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 basic racial and ethnic categories. (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 (OMB) 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) 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 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
C22692 Parent birth country name ParentBirthCntryName Name for country where the parent, guardian, or caregiver was born Name for country where the parent, guardian, or caregiver was born What is the parent's, guardian's, or caregiver's birth country name? 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 255

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C18821 School placement other text SchoolPlacementOTH The free-text field related to 'School placement type' specifying other text. The description of the type of education the participant/subject receives with details of being with or without assistance The free-text field related to 'School placement type' specifying other text. The description of the type of education the participant/subject receives with details of being with or without assistanc Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C21799 Living situation before injury type LivingSituationPreInjTyp Living situation of the participant/subject before injury Living situation of the participant/subject before injur What was the subject's living situation before injury? Homeless/lives in shelter;Lives alone;Lives in group home/assisted living;Lives with friend(s) or roommate(s) or cohabiting;Lives with spouse and/or other family member(s);Data Missing/Refused/Unknown;Other, specify Homeless/lives in shelter;Lives alone;Lives in group home/assisted living;Lives with friend(s) or roommate(s) or cohabiting;Lives with spouse and/or other family member(s);Data Missing/Refused/Unknown;Other, specify Alphanumeric

Living situation of the participant/subject before injury.

Adult;Pediatric Supplemental 1.00 2016-06-03 10:34:36.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21982 Sport college other participation text SportCollegeOtherPlaydTxt College sports played other than primary sport College sports played other than primary sport Which other sports did the subject play in college? Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 18:28:08.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C04814 Residence type ResdncTyp Type of residence where the participant/subject is currently living Type of residence where the participant/subject is currently living What type of residence does the subject currently live in? 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 Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22707 Education level USA type other text EduLvlUSATypOTH The free-text field related to Education level USA type specifying other text. The highest level of education the participant/subject received The free-text field related to Education level USA type specifying other text. The highest level of education the participant/subject receive Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-08-22 10:51:20.0 FITBIR Demographics Form Demographics Participant Characteristics 255

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CSV