CDE Detailed Report
Subdomain Name: Demographics
CRF: welcome
Displaying 101 - 123 of 123
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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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| 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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| 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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| 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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| 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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| 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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| 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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| C21986 | Sport recreational participation total year count | SportRecreationlPrimryYrsCt | Total number of years the participant/subject played primary sport recreationally | Total number of years the participant/subject played primary sport recreationally | How many years did the subject play the primary recreational sport? | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:32:23.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | |||||||||||
| 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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| 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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| 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 | ||||||||
| C19259 | Occupation primary other status text | OccupationPrimaryOthrStatusTxt | The free-text field to capture other status indicating the participant's/subject's current primary occupational status | The free-text field to capture other status indicating the participant's/subject's current primary occupational statu | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-06-06 09:12:40.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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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 |
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| C00206 | Family income supported persons count | FamilyIncmeSupprtPersCt | Count of all people, including the participant/subject, who are supported by the household gross annual income reported | Count of all people, including the participant/subject, who are supported by the household gross annual income reported | What is the number of people supported by the above income? | Numeric Values |
Add date stamp for when assessed. Recommend collection at least on date of TBI and perhaps after all initial medical treatment. |
American Community Survey questionnaire. U.S. Department of Commerce, U.S. Census Bureau. http://www.census.gov/acs/www/Downloads/questionnaires/2012/Quest12.pdf | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
1 | 99 | ||||||||
| C22697 | Parent residence type | ParentResdncTyp | Type of residence where the participant's/subject's parent, guardian, or caregiver is currently living | Type of residence where the participant's/subject's parent, guardian, or caregiver is currently living | What type of residence does the parent, guardian, or caregiver currently live? | Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center | Hospital;Nursing home;Home;N/A - patient died;Other, specify;Unknown;Rehabilitation center | Alphanumeric |
Choose one. Add date and time stamp for when assessed. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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