CDE Detailed Report
Disease: Traumatic Brain Injury
Subdomain Name: Demographics
CRF: FITBIR Demographics Form
Displaying 1 - 50 of 123
Subdomain Name: Demographics
CRF: FITBIR Demographics Form
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
| 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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| 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 | ||||||||
| 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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| 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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| 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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| 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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| 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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| 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 | |||||||
| 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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| 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 | |||||||||||
| C18658 | Employment expanded status | EmplmtExpndStatus | Status of participant/subject's current employment (expanded list) | Status of participant/subject's current employment (expanded list) | What is the status of the subject's current employment? | Working full time;Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment;Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce;Unable to obtain information;Unknown | Working full time (35 hrs or more/week, at least minimum wage);Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment (sheltered workshop, supportive employment, job coach);Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce (including child, retired, student, homemaker, disabled pre-injury);Unable to obtain information;Unknown | Alphanumeric |
Prior TBI studies utilized the Employment Status data element for data capture Choose one. |
National Health and Nutrition Examination Survey (http: //www.cdc.gov/nchs/nhanes.htm) | Adult;Pediatric | Supplemental | 1.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21817 | Sport elementary school other participation total year count | ElemntrySchoolSportOtherYrsCt | Total combined number of years the participant/subject played other sport(s) in elementary school | Total combined number of years the participant/subject played other sport(s) in elementary school | What are the total combined years the subject played the other sports in elementary school? | Numeric Values |
Total combined number of years the participant played other sport(s) in elementary school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 12:00:40.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 100 | |||||||||
| C00026 | Language spoken Fluent text | LangSpokeFluentTxt | Text for each language that the participant/subject speaks fluently | Text for each language that the participant/subject speaks fluently | Please list each language the subject can speak fluently: | Alphanumeric |
Text for all languages participant/subject speaks fluently. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes. 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 | 255 |
Free-Form Entry |
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| C22688 | Parent Race USA Category | ParentRaceUSACat | The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories | The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categorie | What is the parent, guardian, or caregiver's race, based on the OBM race standards? | American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;White;Unknown;Not Reported | A person having origins in any of the original peoples of North and South America (including Central America) , and who maintains tribal affiliation or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.;A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" can be used in addition to "Black or African American.";A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.;Could not be determined or unsure;Not provided or unavailable | Alphanumeric |
The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories. Choose all that apply. Response is obtained by report of the participant/subject or caretaker. Collecting information on race may not be allowed in some countries for concerns related to discrimination. In other countries, however, these concerns are considered a reason for recording race in order to guarantee equal access to care. Investigators receiving funding from the US National Institutes of Health (NIH) are required to report the number of subjects enrolled on an annual basis using the racial categories listed. |
Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | ||||||||
| C22699 | Parent employment expanded status | ParentEmplmtExpndStatus | Status of the participant's/subject's parent, guardian, or caregiver's current employment | Status of the participant's/subject's parent, guardian, or caregiver's current employment | What is the status of the parent's, guardian's, or caregiver's current employment? | Working full time;Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment;Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce;Unable to obtain information;Unknown | Working full time (35 hrs or more/week, at least minimum wage);Working 20-34 hrs/week, at least minimum wage;Working less than 20 hrs/week, at least minimum wage;Temporary/odd jobs/less than minimum wage jobs;Special employment (sheltered workshop, supportive employment, job coach);Sick leave or maternity leave;Unemployed;Other, specify;Not in paid workforce (including child, retired, student, homemaker, disabled pre-injury);Unable to obtain information;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21114 | Visit post baseline day count | VisitPostBaselineDayCt | The number of days since baseline visit | The number of days since baseline visi | The number of days since baseline | Numeric Values |
Enter the number of days passed since the baseline visit |
Adult;Pediatric | Supplemental | 1.00 | 2015-06-12 14:49:48.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Free-Form Entry |
day | ||||||||||
| C21978 | Sport college participation indicator | SportCollegePartInd | Indicator whether the participant/subject played sports in college | Indicator whether the participant/subject played sports in colleg | Did the subject participate in sports in college? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult | Supplemental | 1.00 | 2016-06-06 18:13:59.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00208 | Military USA service branch type | MilUSAServBrnchTyp | Branch of service in the U.S. military, not including the Commissioned Corps | Branch of service in the U.S. military, not including the Commissioned Corps | Which branch of service in the U.S. Military is the subject involved? | Air force;Army;Marine Corps;Navy;Coast Guard;Other, specify;Air Force Reserve;Army Reserve;Coast Guard Reserves;Navy Reserves;Marine Corps Reserves;Air National Guard;Army National Guard | Air force;Army;Marine Corps;Navy;Coast Guard;Other, specify;Air Force Reserve;Army Reserve;Coast Guard Reserves;Navy Reserves;Marine Corps Reserves;Air National Guard;Army National Guard | Alphanumeric |
Choose one. Response is obtained by report of the participant/subject or relatives. |
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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| C15983 | Education type | EduTyp | The type of education the participant/subject received | The type of education the participant/subject receive | What type of education did the subject receive? | Public;Private;Home school;Other, specify | Public;Private;Home school;Other, specify | Alphanumeric |
Choose all that apply |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C21806 | Parent alive status | ParentAliveStatus | Specifies whether the participant's/subjects parents are still living | Specifies whether the participant's/subjects parents are still living | What are the living statuses of the subject's parents? | Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown | Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown | Alphanumeric |
Specifies whether the participant's/subjects parents are still living Answer for both parents |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:20:14.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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| C00004 | Birth country ISO code | BirthCntryISOCode | Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born | Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born | What is the subject's birth country (use ISO code)? | AU;CA;MX;GB;US | AUSTRALIA;CANADA;MEXICO;UNITED KINGDOM;UNITED STATES | 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 | 2013-07-24 21:00:23.88 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C21989 | Sport professional participation indicator | SportProfessionlPartInd | Indicator whether the participant/subject played sports professionally | Indicator whether the participant/subject played sports professionall | Did the subject participate in professional sports? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult | Supplemental | 1.00 | 2016-06-06 18:35:21.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C18676 | Employment expanded other text | EmplmtExpndOTH | The free-text field related to 'Employment expanded status' specifying other text. Status of participant/subject's current employment | The free-text field related to 'Employment expanded status' specifying other text. Status of participant/subject's current employment | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C21818 | Sport junior high participation indicator | JuniorHighSchoolSportInd | The indicator related to whether participant/subject played sports in junior high school | The indicator related to whether participant/subject played sports in junior high school | Did the subject participate in sports in junior high school? | No;Yes | No;Yes | Alphanumeric |
The indicator related to whether subject played sports in junior high school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 12:46:21.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00027 | Language written Fluent text | LangWrtnFlntlyTxt | Text for each language that the participant/subject writes fluently | Text for each language that the participant/subject writes fluently | Please list each language the subject can write fluently: | Alphanumeric |
Text for all languages participant/subject writes fluently. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes. |
ISO 639-2 language codes (http://www.loc.gov/standards/iso639-2/php/code_list.php) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C22689 | Parent race expanded category | ParentRaceCat | Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with | Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with | What is the parent/guardian, or caregiver's race, using expanded race 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 |
Category of race(s) or region(s) the parent, guardian, or caregiver most closely identifies with 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. |
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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| C22700 | Parent job classification category | ParentJobclassCat | Category that classifies work performed by the participant's/subject's parent, guardian, or caregiver | Category that classifies work performed by the participant's/subject's parent, guardian, or caregive | What is the parent, guardian, or caregiver's job classification? | Agricultural or fishery worker;Armed forces occupation;Clerk;Craft and related trades workers;Elementary occupations;Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Professional referral;Service or sales worker;Technicians and associate professionals;Not applicable;Unknown;Other, specify | Agricultural or fishery worker;Armed forces occupation (officers, service personnel);Clerk;Craft and related trades workers (e.g. motor mechanic, printer, tool and die makers, electrician);Elementary occupations (laborer, porter, unskilled workers);Legislator, or senior official, or manager;Plant and machine operators and assemblers;Professional;Professional referral;Service or sales worker;Technicians and associate professionals (typically requiring a Bachelor degree or equivilent);Not applicable;Unknown;Other, specify | Alphanumeric | 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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| C21759 | Primary other person shared living adult patient text | SesPrimAdultOTH | Primary person living with adult patient | Primary person living with adult patient | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2016-06-02 13:29:06.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 256 |
Free-Form Entry |
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| C21979 | Sport college primary participation type | SportCollegePrimaryPartTyp | The primary sport the participant/subject played in college | The primary sport the participant/subject played in colleg | What was the primary sport the subject played in college? | Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing | Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing | Alphanumeric | Adult | Supplemental | 1.00 | 2016-06-06 18:24:16.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00214 | Living with persons count | PrsnCohabitCt | Count of other people with whom the participant/subject currently lives, cohabits, or stays | Count of other people with whom the participant/subject currently lives, cohabits, or stays | What is the count of other people with whom the subject currently lives, cohabits, or stays? | Numeric Values |
Include everyone who is living or staying here for more than 2 months. Include participant/subject if they are living here for more than 2 months. Include anyone else staying here who does not have another place to stay even if they are here for 2 months or less. Do not include anyone who is living somewhere else for more than 2 months, such as college student living away or someone in the Armed Forces on deployment. Answer should be recorded as a 2 digit number (i.e., one should be recorded as 01, ten should be recorded as 10). Participant/subject should NOT be included. |
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 |
0 | 99 | ||||||||
| C15989 | Unemployed reason | UnemplymntRsn | Participant's/subject's reason for unemployment | Participant's/subject's reason for unemployment | What is the subject's reason for being unemployed? | Alphanumeric |
Specify the reason for unemployment |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C21807 | Military occupational status | MilMOS | Military occupational status of participant/subject | Military occupational status of participant/subject | What is the military occupational status of the subject? | Non-combat;Combat;Other, specify | Non-combat;Combat;Other, specify | Alphanumeric |
Military occupational status of participant |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 11:21:24.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C00005 | Birth country name | BirthCntryName | Name for country where the participant/subject was born | Name for country where the participant/subject was born | What is the subject's birth country name? | Alphanumeric |
Text for participant/subject's birth country. It may be easier to record the full name of the country and code the data later in Birth country ISO code using the ISO 3166-1 alpha-2 codes. |
Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 21:00:23.88 | FITBIR Demographics Form | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C21990 | Sport professional primary participation type | SportProfessionlPrimryPlaydTyp | The primary sport the participant/subject played professionally | The primary sport the participant/subject played professionall | What was the primary professional sport the subject played? | Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing | Ice Hockey;Diving;Golf;Soccer;Water polo;Equestrian;Football;Lacrosse;Ice Skating;Skiing;Basketball;Baseball;Gymnastics;Swimming;Boxing;Rifle;Bowling;Field Event;Field Hockey;Softball;Volleyball;Figure skating;Rowing;Cross Country / Track;Tennis;Other, specify;Wrestling;Fencing | Alphanumeric | Adult | Supplemental | 1.00 | 2016-06-06 18:36:16.0 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C18739 | Military USA service branch other text | MilUSAServBrnchOTH | The free-text field related to 'Military USA service branch type' specifying other text. Branch of service in the U.S. military, not including the Commissioned Corps | The free-text field related to 'Military USA service branch type' specifying other text. Branch of service in the U.S. military, not including the Commissioned Corps | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C21819 | Sport junior high primary participation text | JuniorHighPrimrySportPlayedTxt | The indicator related to which sports participant/subject played in junior high school | The indicator related to which sports participant/subject played in junior high school | What was the primary sport the subject played in junior high school? | Alphanumeric |
The indicator related to which sports subject played in junior high school |
Adult;Pediatric | Supplemental | 1.00 | 2016-06-03 12:47:49.0 | FITBIR Demographics Form | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C00028 | Language spoken fluent ISO code | LangSpokeFluentISOCode | Code (ISO 639-2)for each language that the participant/subject speaks fluently | Code (ISO 639-2)for each language that the participant/subject speaks fluently | What are the ISO codes for each language the subject can speak fluently? The ISO codes represent the international codes for different countries. | English (eng);German (ger);Other specify;Chinese languages (Chi);fre;sgn;Spanish (spa) | English (eng);German (ger);Other specify;Chinese languages (Chi);French;Sign Languages;Spanish (spa) | Alphanumeric |
Choose all that apply. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes. 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 |
Multiple Pre-Defined Values Selected |
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| C22690 | Parent Ethnicity USA category | ParentEthnUSACat | Category of ethnicity the parent, guardian, or caregiver most closely identifies with | Category of ethnicity the parent, guardian, or caregiver most closely identifies with | What is the parent's, guardian's, or caregiver's ethnicity? | 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 |
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. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and 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) |
Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | FITBIR Demographics Form | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 |
