CDE Detailed Report
Disease: Traumatic Brain Injury
Subdomain Name: Demographics
CRF: FITBIR Demographics Form
Displaying 101 - 123 of 123
Subdomain Name: Demographics
CRF: FITBIR Demographics Form
Displaying 101 - 123 of 123
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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 |
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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| 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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| 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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| 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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| 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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| 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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| C21987 | Sport recreational other participation text | SportRecreationlOtherPlaydTxt | Which other sport(s) the participant/subject played recreationally | Which other sport(s) the participant played/subject recreationally | Which other recreational sports did the subject play? | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:33:20.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C12605 | Caregiver primary type | CaregvrPrimryType | Type of relationship that the person who serves as the participant/subject's primary caregiver has with the participant/subject | Type of relationship that the person who serves as the participant/subject's primary caregiver has with ther participant/subject | Who is the primary person living with the subject? | Alone;Child;Group living situation, boarding house;Homeless;Military barracks;Other;Other patients (in hospital/nursing home);Other residents;Other, specify;Parent or legal guardian;Personal care attendant;Roommates/friends;Self;Sibling;Spouse or partner;Unable to obtain information | Alone;Child;Group living situation, boarding house;Homeless;Military barracks;Other;Other patients (in hospital/nursing home);Other residents;Other, specify;Parent or legal guardian;Personal care attendant;Roommates/friends;Self;Sibling;Spouse or partner;Unable to obtain information | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C21804 | Job classification current other text | JobClassNowOTH | The free-text field related to Job classification-now specifying other text | The free-text field related to Job classification-now specifying other tex | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:17:16.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C00025 | Language primary text | LangPrimryTxt | Text for the language the participant/subject speaks most often | Text for the language the participant/subject speaks most often | What is the subject's primary language (use ISO code)? | eng;spa;sgn;chi;fre;ger;Other, specify | English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify | Alphanumeric |
Choose one. It may be easier to record the full name of the language using Language primary text and code the data later using the ISO 639-2 alpha-3 codes. Data Sharing Instructions: The language data should be coded using the ISO 639-2 codes prior to aggregation or sharing. |
ISO 639-2 language codes (http: //www.loc.gov/standards/iso639-2/php/code_list.php) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C22687 | Marital or partner status other text | MartlPartnerStatusOTH | The free-text field related to Marital or partner status specifying other text. Status of participant/subjects current domestic relationships | The free-text field related to Marital or partner status specifying other text. Status of participant/subjects current domestic relationship | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-08-01 13:44:07.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C18614 | Education primary caregiver year count | EduPrimCaregiverYrCt | Number of years of education of the primary caregiver (age 5 and beyond) | Number of years of education of the primary caregiver (age 5 and beyond | How many years of education does the parent, guardian, or caregiver have? | Numeric Values |
In order to apply to international setting, this data element was made to supplement C00013 |
Adult;Pediatric | Supplemental | 3.00 | 2013-10-07 00:00:00.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 30 | year | ||||||||
| C21816 | Sport elementary school other participation text | ElementarySchoolSportOthrPlayd | The free-text field to specify which other sports the participant/subject played in elementary school | The free-text field to specify which other sports the participant/subject played in elementary school | Which other sports did the subject play in elementary school? | Alphanumeric |
The free-text field to specify which other sports the participant played in elementary school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:59:33.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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