CDE Detailed Report

Disease: content
Subdomain Name: Demographics
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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
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

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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

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

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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

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

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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

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

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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

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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

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
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

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C21980 Sport college participation total year count SportCollegePrimaryYrsCt Total combined years the participant/subject played primary college sport (should be used in combination with Primary college sport played by the participant UDE) Total combined years the participant/subject played primary college sport (should be used in combination with Primary college sport played by the participant UDE How many years did the subject play the primary sport in college? Numeric Values Adult Supplemental 1.00 2016-06-06 18:25:34.0 FITBIR Demographics Form Demographics Participant Characteristics

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C00220 Military USA rank category MilUSARnkCat Category that describes the participant's/subject's rank in the military Category that describes the participant's/subject's rank in the military What is the subject's military rank? Company grade officer;Warrant officer;Non-commissioned officer;Other enlisted rank;Field grade officer or above Company grade officer;Warrant officer;Non-commissioned officer (e.g., sergeant/corporal);Other enlisted rank;Field grade officer or above Alphanumeric

Choose one. Response is obtained by report of the participant/subject or relatives. NATO rank specifications could be used instead, but military personnel are typically unfamiliar with these ranks (i.e., they do not know their own NATO rank specification). Ranks generally reflect level of responsibility and type of activities engaged in while in theatre - information that may correlate with risk/severity/type of injury.
If Active, Active reserves Inactive or Civilian Military Contractor, specify. Military service status.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22701 Parent unemployed reason ParentUnemplymntRsn Participant's/subject's parent, guardian, or caregiver's reason for unemployment Participant's/subject's parent, guardian, or caregiver's reason for unemployment What is the parent, guardian, or caregiver'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

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C21794 Living situation juvenile patient type SesPrimChild Living situation of juvenile patient Living situation of juvenile patient What is the subject's living situation? Adoptive parents;Foster care;Other family member;Parent;Unable to obtain information;Other, specify Adoptive parents;Foster care;Other family member;Parent;Unable to obtain information;Other, specify Alphanumeric

Living situation of juvenile patient

Adult;Pediatric Supplemental 1.00 2016-06-02 15:03:52.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C21808 Military occupational status other text MilMOSOTH Military occupational status of participant/subject other text Military occupational status of participant/subject other text Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-03 11:23:15.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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C00007 Birth date BirthDate Date (and time, if applicable and known) the participant/subject was born Date (and time, if applicable and known) the participant/subject was born What is the subject's date of birth? 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.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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.

ISO 8601 - http: //www.iso.org/iso/iso_catalogue.htm Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17: 573-581.<br />Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2): 259-69. <br />Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatric 116: 1374-1382 Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 FITBIR Demographics Form Demographics Participant Characteristics

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C21991 Sport professional participation total year count SportProfessPrimPartTtlYrsCt Total combined years the participant/subject played primary professional sport (should be used in combination with Primary professional sport played by the participant/subject CDE) Total combined years the participant/subject played primary professional sport (should be used in combination with Primary professional sport played by the participant/subject CDE) What is the total number of years the subject played the primary professional sports? Numeric Values

Use in combination with Primary professional sport played by the participant UDE.

Adult Supplemental 1.00 2016-06-06 18:37:01.0 FITBIR Demographics Form Demographics Participant Characteristics

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C15993 Dependent children number DpndntChildNum Number of dependent children Number of dependent children What is the total number of dependents children the subject has? Numeric Values

Number of dependent children for a participant/subject

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 FITBIR Demographics Form Demographics Participant Characteristics

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C21820 Sport junior high participation year count JuniorHighPrimarySprtYrsCt The number of years participant/subject played sport(s) in junior high school The number of years participant/subject played sport(s) in junior high school How many years did the subject play the primary sport in junior high school? 1;2;3;4;5;6 1;2;3;4;5;6 Numeric Values

The number of years subject played sport(s) in junior high school

Adult;Pediatric Supplemental 1.00 2016-06-03 12:48:46.0 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00029 Language written fluent ISO code LangWrtnFlntlyTxtISOCode Code (ISO 639-2) for each language that the participant/subject writes fluently Code (ISO 639-2) for each language that the participant/subject writes fluently What are the ISO codes for each language the subject can write fluently? Alphanumeric

Enter all that apply

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

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C22691 Parent birth country ISO code ParentBirthCntryISOCode Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was born Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was bor What is the parent's, guardian's, or caregiver's birth country ISO code? AU;CA;MX;GB;US AUSTRALIA;CANADA;MEXICO;UNITED KINGDOM;UNITED STATES Alphanumeric

Choose one. 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.

Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born

Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 FITBIR Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C18747 Residence other text ResdncOTH The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living The free-text field related to 'Residence type' specifying other text. Type of residence where the participant/subject is currently living Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 FITBIR Demographics Form Demographics Participant Characteristics 4000

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CSV