CDE Detailed Report
Disease: content
Sub-Domain: Demographics
CRF: welcome
Displaying 1 - 50 of 123
Sub-Domain: Demographics
CRF: welcome
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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| 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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 |
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| C00008 | Age value | AgeVal | Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject | Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subjec | 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 | 3.00 | 2013-08-28 16:08:00.453 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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| C21810 | Military deployment location other text | MilDeployOTH | Region or country to where participant/subject was deployed other text | Region or country to where participant/subject was deployed other text | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:26:09.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C00012 | Education level USA type | EduLvlUSATyp | Highest grade or level of school participant/subject has completed or the highest degree received | Highest grade or level of school participant/subject has completed or the highest degree received | What best describes the highest level the subject completed in school? | Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational/technical/vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown | Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational/technical/vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown | Alphanumeric |
Choose the highest level attained by the participant/subject. |
National Health and Nutrition Examination Survey (NHANES); National Health Interview Survey (NHIS); PhenX Toolkit Current Educational Attainment #011001 (https: //www.phenxtoolkit.org) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
3134878 | |||||||
| C21993 | Sport professional other participation text | SportProfessionlOtherPartTxt | Professional sports played other than primary sport | Professional sports played other than primary sport | Which other professional sports did the subject play? | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:39:11.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C15995 | Household wage earners number | HshldWgeEarnNum | Number of wage earners in household | Number of wage earners in household | How many wage earners live in the subject's household? | Numeric Values |
Refer to Household and Income. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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| C19036 | Education other text | EduOTH | The free-text field related to 'Education type' specifying other text. The type of education the participant/subject received | The free-text field related to 'Education type' specifying other text. The type of education the participant/subject receive | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C21822 | Sport junior high other participation year count | JuniorHighSportOtherYrsCt | Total combined number of years participant/subject played sport(s) junior high school | Total combined number of years participant/subject played sport(s) junior high school | How many total combined years did the subject play other sports in junior high school? | Numeric Values |
Total combined number of years subject played sport(s) junior high school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 12:52:39.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 100 | |||||||||
| C00031 | Race expanded category | RaceCat | Category of race(s) or region(s) the participant/subject most closely identifies with | Category of race(s) or region(s) the participant/subject most closely identifies with | What is the subject's racial background (expanded 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 |
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. |
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) <br />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 | 2013-07-22 16:57:17.79 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C22693 | Parent marital or partner status | ParentMartlPartnerStatus | Status of participant's/subject's parent, guardian, or caregiver's current domestic relationship, whether marital or partnered | Status of participant's/subject's parent, guardian, or caregiver's current domestic relationship, whether marital or partnered | What is the parent's, guardian's, or caregiver'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 Status of participant/subjects current domestic relationship, whether marital or partnered |
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 | |||||||
| C21800 | Living situation before injury other text | LivingSituationPreInjTypOTH | Living situation of the participant/subject before injury other text | Living situation of the participant/subject before injury other tex | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 10:38:50.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C21983 | Sport college other participation total year count | SportCollegeOtherYrsCt | Total combined years the participant/subject played other college sport(s) (should be used in combination with Other sport(s) the participant played in college) | Total combined years the participant/subject played other college sport(s) (should be used in combination with Other sport(s) the participant played in college | How many total combined years did the subject play other sports in college? | Numeric Values |
Use in combination with Other sport(s) the participant played in college UDE |
Adult | Supplemental | 1.00 | 2016-06-06 18:29:02.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
1 | 50 | |||||||||
| C08147 | Data source | DataSource | Source of the data provided on the case report form | Source of the data provided on the case report form | Who is the source of this information in relation to the subject? | Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse | Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse | Alphanumeric |
Choose all that apply |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:46:24.96 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C22708 | Parent ethnicity USA category other text | ParentEthnUSACatOTH | The free-text field describing the category of ethnicity the participant's/subject's parent/guardian most closely identifies with | The free-text field describing the category of ethnicity the participant's/subject's parent/guardian most closely identifies wit | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-08-22 11:45:27.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C21812 | Sport head neck injury indicator | TBISportInd | The indicator related to having a injury of head or neck in sports | The indicator related to having a injury of head or neck in sport | Was the subject's traumatic brain injury sports related? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
The indicator related to having a injury of head or neck in sports. |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:54:50.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00013 | Education level primary caregiver USA type | EduLvlPrimCaregiverUSATyp | Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received | Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received | What is the parent's, guardian's, or caregiver's highest grade or level of school completed? | Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown | Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown | Alphanumeric |
Choose the highest level attained by the participant/subject's primary caregiver. This element is recommended for Pediatric stroke studies. Choose highest level attained. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21994 | Sport professional participation other total year count | SportProfessionPartOthTtlYrsCt | Total combined years the participant/subject played other professional sport(s) (should be used in combination with Other professional sports played by the participant/subject | Total combined years the participant/subject played other professional sport(s) (should be used in combination with Other professional sports played by the participant/subjec | What is the total number of years the subject played other professional sports? | Numeric Values |
Use in combination with Other professional sports played by the participant UDE |
Adult | Supplemental | 1.00 | 2016-06-06 18:40:17.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
1 | 50 | |||||||||
| C17396 | Sex genotype type | SexGenotypTyp | The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement | Sex chromosomes of the participant/subject based upon genotyping | What is the subject's sex or genotype? | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex | Alphanumeric |
Choose only one Added to TBI per meeting with FITBIR on 12/18/13. |
Adult;Pediatric | Core | 3.10 | 2018-07-26 00:00:00.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C19247 | Subject ID | SubIDNam | Subject identification ID | Subject identification ID | Subject ID Number | Alphanumeric |
The participant or subject identifiers or IDs should be assigned by the study. SCI Variable: SUBJECT |
Alexander MS, Biering-Saarensen F, Elliott S, Kreuter M, Saanksen J. International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set. Spinal Cord. 2011 Jul;49(7):787-90. Alexander MS, Biering-SØrensen F, Elliott S, Kreuter M, SØnksen J. International spinal cord injury male sexual function basic data set. Spinal Cord. 2011 Jul;49(7):795-8.<br />Bauman WA, Biering-Saarensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10):1068-72.<br />Biering-Saarensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30.<br />Krogh K, Perkash I, Stiens SA, Biering-Saarensen F. International bowel function extended spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):235-41.<br />Widerstraam-Noga E, Biering-Saarensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. | Adult;Pediatric | Supplemental | 1.00 | 2014-06-05 13:10:49.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C21973 | Sport high school participation indicator | SportHighSchoolInd | Whether participant/subject played sports in high school | Whether participant/subject played sports in high school | Did the subject participate in sports in high school? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:07:34.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject | Self-reported gender of the participant/subjec | What is the subject's gender? | Alphanumeric |
Choose one. Response is obtained by report of the participant/subject or caretaker. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http: //grants.nih.gov/grants/funding/women_min/guidelines_update.htm) | Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2200604 | |||||||||
| C22694 | Parent dependent children liviing in household number | ParentDpndntChildLvngHshldNum | Number of dependent children living in parent's, guardian's or caregiver's household | Number of dependent children living in parent's, guardian's or caregiver's household | What is the number of dependent children living in the parent, guardian, or caregiver's household? | Numeric Values |
Refer to Household and Income. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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| C21801 | Education highest level before injury type | HighestLvlEduPreInj | Highest level education pre-injury | Highest level education pre-injury | What is the highest level of education the subject received pre-injury? | None/basic primary = 0 - 4 years;Primary/Intermediate Primary = 5 - 8 years;Secondary = 12 years;Tertiary = 13 - 15 years (e.g., Teachers, Technicians);University = 16 - 17 years;Post Graduate = 18-19 years (e.g., Masters, Doctoral);Unknown | None/basic primary = 0 - 4 years;Primary/Intermediate Primary = 5 - 8 years;Secondary = 12 years;Tertiary = 13 - 15 years (e.g., Teachers, Technicians);University = 16 - 17 years;Post Graduate = 18-19 years (e.g., Masters, Doctoral);Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 10:54:09.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21984 | Sport recreational participation indicator | SportRecreationlPartInd | Whether the participant/subject played recreational sports | Whether the participant/subject played recreational sports | Did the subject participate in recreational sports? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:30:14.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C10467 | Risk Factor Questionnaire (RFQ) - military service current active status | RFQMilSrvcCurrActStatus | The status whether the participant/subject is currently active in the military as part of the Risk Factor Questionnaire (RFQ) - Occupation | The status whether the participant/subject is currently active in the military as part of the Risk Factor Questionnaire (RFQ) - Occupatio | Is the subject active military? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Whether participant currently has active military status |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 09:11:50.26 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21813 | Sport elementary school participation indicator | ElementarySchoolSprtInd | The indicator related to whether participant/subject participated in sport(s) in elementary school | The indicator related to whether participant/subject participated in sport(s) in elementary school | Did the subject participate in sports in elementary school? | No;Yes | No;Yes | Alphanumeric |
The indicator related to whether subject participated in sport(s) in elementary school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:56:15.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00015 | Education year count | EduYrCt | Number of years of education completed (age 5 and beyond) | Number of years of education completed (age 5 and beyond) | How many years of education does the subject have? | Numeric Values |
Choose the highest level attained by the participant/subject caBIG CDE Public ID = 3134878 For years completed, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 30 | year | 3134878 | |||||||
| C22682 | Case Control Indicator | CaseContrlInd | The response related to whether subject is in the case or control arm of the study | Indicator of whether subject is in the case or control arm of the study | Is the subject in the case or control arm of the study? | Case;Control;Unknown | Case;Control;Unknown | Alphanumeric |
Indicate whether subject is (was) in the case or control arm of the study |
Adult;Pediatric | Supplemental | 1.00 | 2016-07-27 13:36:42.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
