CDE Detailed Report
Disease: content
Subdomain Name: Demographics
CRF: welcome
Displaying 101 - 123 of 123
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 / Guideline) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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 |
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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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| 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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| 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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| 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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| 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 | ||||||||
| C21977 | Sport high school other participation total year count | SportHighSchoolOtherYrsCt | Total combined number of years participant/subject played other sport(s) in high school | Total combined number of years participant/subject played other sport(s) in high school | How many total combined years did the subject play other sports in high school? | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:12:55.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | |||||||||||
| C00207 | Marital or partner status | MartlPartnerStatus | Status of participant/subject's current domestic relationship, whether marital or partnered | Status of participant/subject's current domestic relationship, whether marital or partnered | What is the subject'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 |
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 | |||||||
| C22698 | Parent occupation primary status | ParentOccupationPrimaryStatus | The status indicating the participant's/subject's parent, guardian, or caregiver's current primary occupational status | The status indicating the participant's/subject's parent, guardian, or caregiver's current primary occupational statu | What is the parent's, guardian's, or caregiver'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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| C19287 | Income basic needs status | IncomeBasicNeedsStatus | The status of how the household currently manages to meet basic needs as defined by food, shelter and clothing | The status of how the household currently manages to meet basic needs as defined by food, shelter and clothin | Does the subject's income meet the subject's household's basic needs? | Very well;Very poorly;Unknown;Refused to answer;Rather well;Rather poorly;Adequately (neither well nor poorly) | Very well;Very poorly;Unknown;Refused to answer;Rather well;Rather poorly;Adequately (neither well nor poorly) | Alphanumeric | Adult | Supplemental | 1.00 | 2014-06-06 11:03:24.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21805 | Caregiver primary extended type | CaregvPrimryExtendType | Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject | Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject | What is the relationship between the person who acts as the primary caregiver for the subject and the subject? | Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify | Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify | Alphanumeric |
Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:18:55.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C21988 | Sport recreational other participation year count | SportRecreationlOtherYrsCt | Total number of years participant/subject played other sport(s) recreationally | Total number of years participant/subject played other sport(s) recreationally | How many total combined years did the subject play other recreational sports? | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2016-06-06 18:34:23.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | |||||||||||
| C14123 | Country of residence name | CntryResdnceName | Country where the participant/subject currently lives | Country where the participant/subject currently live | What is the subject's current country of residence name? | Alphanumeric |
This CDE should be used in combination with Country of residence ISO code CDE when there is no ISO code available for the country name. 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. |
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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