CDE Detailed Report
Disease: content
Subdomain Name: Demographics
CRF: welcome
Displaying 1 - 50 of 123
Subdomain Name: 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 / 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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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| 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 | |||||||
| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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 |
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| C17399 | Global unique identifier number | GlobalUniqueIdNum | Number representing the Global Unique ID (GUID) which uniquely identifies a participant | Number representing the Global Unique ID (GUID) which uniquely identifies a participant | GUID | Alphanumeric | Johnson SB, Whitney G, McAuliffe M, Wang H, McCreedy E, Rozenblit L, Evans CC. Using global unique identifiers to link autism collections. J Am Med Inform Assoc. 2010;17(6):689-95. doi: 10.1136/jamia.2009.002063. | Adult;Pediatric | Supplemental | 3.10 | 2024-02-29 15:54:17.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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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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| C21974 | Sport high school primary participation indicator | SportHighSchoolPrimryPartInd | The primary sport the participant/subject played in high school | The primary sport the participant/subject played in high school | What was the primary sport the subject played in high school? | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:09:32.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C00202 | Education school participation status | EduSchoolParticipStatus | Status of participant/subject's current attendance at school | Status of participant/subject's current attendance at school | What is the subject's current attendance in school? | Going to school;On vacation from school (between grades);Neither;Unknown | Going to school;On vacation from school (between grades);Neither;Unknown | Alphanumeric | National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm) | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C22695 | Parent dependent children number | ParentDpndntChildNum | Number of dependent children the participant's/subject's parent, guardian, or caregiver has | Number of dependent children the participant's/subject's parent, guardian, or caregiver has | What is the total number of dependent children the parent, guardian, or caregiver's has? Include both living in the household and living elsewhere. | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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| C19257 | Residence area type | ResidenceAreaTyp | Type describing the participant's/subject's current location of residence | Type describing the participant's/subject's current location of residence | How would you describe the subject's current location of residence? | A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown | A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-06-05 17:27:45.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21985 | Sport recreational primary participation text | SportRecreationlPrimryPlaydTxt | Which sport the participant/subject primarily played recreationally | Which sport the participant/subject primarily played recreationally | What is the primary recreational sport played by the subject? | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:31:07.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C10676 | Country of residence code | CntryResdnceISOCode | Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives | Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently live | What is the subject's current country of residence? | US;CA;GB;MX;AU;Other, specify | USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify | Alphanumeric |
Choose only one country which the subject/participant currently lives. If the country code is not included on the form then code the data later using ISO 3166-1 alpha-2 codes. If ISO code does not exist, use Country of residence name CDE to write the country name. Choose only one country which the subject/participant currently lives. If the country code is not included on the form, then code the data later using ISO 3166-1 alpha-2 codes. ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) |
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21802 | Job classification before injury category | JobClassPreInj | Job classification pre-injury | Job classification pre-injury | What was the subject's pre-injury job classification? | Agricultural or fishery worker;Armed forces occupation;Clerk;Craft and related trades workers;Elementary occupations;Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Service or sales worker;Technicians and associate professionals;Not applicable;Unknown;Other, specify | Agricultural or fishery worker;Armed forces occupation (officers, service personnel);Clerk;Craft and related trades workers (e.g. motor mechanic, printer, tool and die makers, electrician);Elementary occupations (laborer, porter, unskilled workers);Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Service or sales worker;Technicians and associate professionals (typically requiring a Bachelor degree or equivilent);Not applicable;Unknown;Other, specify | Alphanumeric |
For detailed definitions go to: http://www.who.int/healthinfo/survey/whsshortversionguide.pdf |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 10:56:59.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21814 | Sport elementary school primary participation text | ElementarySchoolPrimaryPlayed | The free-text field to specify the primary sport the participant/subject played in elementary school | The free-text field to specify the primary sport the participant/subject played in elementary school | What was the primary sport the subject played in elementary school? | Alphanumeric |
The free-text field to specify the primary sport the participant played in elementary school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:57:17.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C00020 | Ethnicity USA category | EthnUSACat | Category of ethnicity the participant/subject most closely identifies with | Category of ethnicity the participant/subject most closely identifies with | What is the subject's ethnic background? | Hispanic or Latino;Not Hispanic or Latino;Unknown;Not reported;Other, specify | A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino.";A person not meeting the definition for Hispanic or Latino.;Could not be determined or unsure;Not reported;Other, specify | Alphanumeric |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Choose one. Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be "collapsible" up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list. Budget Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. | Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
| C22683 | Context type | ContextType | The context to which the questions were answered, e.g., since the last interview or after the injury | The context to which the questions were answered, e.g., since the last interview or after the injur | Time frame related context (if any) to which the questions were answered | After injury;At time of assessment;Before injury;Last 2 weeks;Last 6 months;Last 24 hours;Last month;Last week;Last year;Prior to death;Since last interview;Time of injury;Other, specify | After injury;At time of assessment;Before injury;Last 2 weeks;Last 6 months;Last 24 hours;Last month;Last week;Last year;Prior to death;Since last interview;Time of injury;Other, specify | Alphanumeric |
This question should be the first required question in the repeatable group which contains time frame, context dependent questions. |
Adult;Pediatric | Supplemental | 1.00 | 2016-07-29 10:50:39.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C17402 | Site name | SiteName | The name of the site for the study | The name of the site for the study | Site Name | Alphanumeric |
Enter the name of the study site |
Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C21975 | Sport high school primary played count | HighSchoolPrimarySportYrsCt | Number of years participant/subject played sport(s) in high school | Number of years participant/subject played sport(s) in high school | How many years did the subject play the primary sport in high school? | 1;2;3;4;5;6 | 1;2;3;4;5;6 | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:10:36.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00205 | Family income range | FmlyIncRng | Range, in U.S. dollars, of the annual pre-tax, pre-deduction total income, of the household of which the participant/subject is a member | Range, in U.S. dollars, of the annual pre-tax, pre-deduction total income, of the household of which the participant/subject is a member | What is the range, in U.S. dollars, of annual pre-tax, pre-deduction total income, of the subject household? | $15,000 to $24,999;$25,000 to $34,999;$35,000 to $49,999;$50,000 to $74,999;$75,000 to $99,999;$100,000 and over;Refused;Unknown;Under $15,000 | $15,000 to $24,999;$25,000 to $34,999;$35,000 to $49,999;$50,000 to $74,999;$75,000 to $99,999;$100,000 and over;Refused;Unknown;Under $15,000 | Alphanumeric |
Choose one. This includes pre-tax cash income earned by persons, money wages and salaries, self-employment income, property income (dividends, interest and rents), money transfer payments from a variety of government and private welfare and social insurance schemes (such as social security, unemployment and workers compensation, and public assistance), private and government retirement income, interpersonal transfers (such as alimony and child support) and other periodic income. This excludes certain lump sum payments and capital gains. Add date stamp for when assessed. Recommend collection at least on date of TBI and perhaps after all initial medical treatment. |
American Community Survey questionnaire. U.S. Department of Commerce, U.S. Census Bureau. http://www.census.gov/acs/www/Downloads/questionnaires/2012/Quest12.pdf | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C22696 | Parent residence area type | ParentResidenceAreaTyp | Type describing the participant's/subject's parent, guardian, or caregiver's current location of residence | Type describing the participant's/subject's parent, guardian, or caregiver's current location of residence | How would you describe the parent, guardian, or caregiver's current location of residence? | A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown | A big city (population >= 250,000) including suburbs/outskirts;A small town/ small city (population 500-10,000);Rural area (population =< 500);Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-06-05 17:27:45.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C19258 | Occupation primary status | OccupationPrimaryStatus | The status indicating the participant's/subject's current primary occupational status | The status indicating the participant's/subject's current primary occupational statu | What is the subject's current primary occupational status? | Homemaker;Other, specify;Paid work;Retired;Retired;Student;Unemployed;Unknown;Unpaid work | Homemaker;Other, specify;Paid work (employed/self-employed, including military);Retired (disability pension);Retired (non-disability);Student (including on the job training);Unemployed (none of the above);Unknown;Unpaid work (volunteer) | Alphanumeric | Adult | Supplemental | 1.00 | 2014-06-06 08:50:45.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21986 | Sport recreational participation total year count | SportRecreationlPrimryYrsCt | Total number of years the participant/subject played primary sport recreationally | Total number of years the participant/subject played primary sport recreationally | How many years did the subject play the primary recreational sport? | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:32:23.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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| C11086 | School placement type | SchoolPlacementTyp | The description of the type of education the participant/subject receives with details of being with or without assistance | The description of the type of education the participant/subject receives with details of being with or without assistanc | What is the type of education the subject receives with details of being with or without assistance? | Full-time regular education without aide;Full-time regular education with one to one aide;Regular education with pull-out for certain areas;Special education w/minimal inclusion (e.g., lunch);Full time special education with no inclusion;Special (MR/DD) school;Home-schooled;Not in school;Other, specify | Full-time regular education without aide;Full-time regular education with one to one aide;Regular education with pull-out for certain areas;Special education w/minimal inclusion (e.g., lunch);Full time special education with no inclusion;Special (MR/DD) school;Home-schooled;Not in school;Other, specify | Alphanumeric |
This element can be collected to describe the participant/subject prior to the stroke event and also to assess the participant/subject at subsequent time points after the stroke event. |
Pediatric | Supplemental | 3.00 | 2013-07-11 15:03:49.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21803 | Job classification before injury other text | JobClassPreInjOTH | The free-text field related to Job classification pre-injury specifying other text | The free-text field related to Job classification pre-injury specifying other tex | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 10:58:31.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C21815 | Sport elementary school participation year count | ElementarPrimarySprtYrsNum | The number of years participant/subject played sport(s) in elementary school | The number of years participant/subject played sport(s) in elementary school | How many years did the subject play the primary sport in elementary school? | 1;2;3;4;5;6 | 1;2;3;4;5;6 | Numeric Values |
The number of years subject played sport(s) in elementary school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:58:23.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00023 | Hand preference type | HandPrefTyp | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel | What is the subject's handedness preference, or dominant hand? | Left hand;Right hand;Both hands;Unknown | Left hand;Right hand;Both hands;Unknown | Alphanumeric |
The purpose of this element is to determine dominant hemisphere; therefore, for those who were originally left handed but forced to write right-handed, record left-handed. Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively Choose the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed. |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430-8. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2180147 | |||||||
| C22684 | Parent gender type | ParentGenderTyp | Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of a parent determined genetically | Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of a parent determined geneticall | What is the parent's, guardian's, or caregiver's gender? | Female;Male;Unknown;Unspecified;Not reported | Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported | Alphanumeric |
Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Choose one. Response is obtained by report of the participant/subject or parent, guardian, or caretaker. |
Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2200604 | ||||||||
| C17409 | Visit date | VisitDate | Date of interview or visit (actually the date when data in the form were captured) | Date of interview or visit | Visit Date | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss. |
21 CFR 50.20 General requirements for informed consent A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Contents (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm#general) | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
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| C21976 | Sport high school other participation text | SportHighSchoolOtherPartTxt | Which sports participant/subject played in high school | Which sports participant/subject played in high school | Which other sports did the subject play in high school? | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:12:02.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
