CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 31 of 31
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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 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.

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.; 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. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382 Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Free-Form Entry

793
C00202 Education school participation status EduSchoolParticipStatus Status of participant/subject's current attendance at school Status of participant/subject's current attendance at school Participant/subject school status Going to school;On vacation from school (between grades);Neither;Unknown Going to school;On vacation from school (between grades);Neither;Unknown Alphanumeric Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C19260 Occupation secondary status OccupationSecStatus The status indicating the participant's/subject's current secondary occupational status. The status indicating the participant's/subject's current secondary occupational status. Secondary Occupation N/A;Other, specify;Homemaker;Paid work;Retired;Retired;Student;Unemployed;Unknown;Unpaid work N/A;Other, specify;Homemaker;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;Pediatric Supplemental 1.00 2014-06-06 09:18:12.0 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00008 Age value AgeVal Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Age Numeric Values

For children younger than one year born at less than 36 weeks gestation, it is recommended to also collect gestational age. 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.

Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382 Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Free-Form Entry

0 1800 month
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 Household income range $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 Exploratory 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C19262 Occupation secondary other status text OccupationSecOtherStatusTxt The free-text field to capture other status indicating the participant's/subject's current secondary occupational status. The free-text field to capture other status indicating the participant's/subject's current secondary occupational status. Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-06 09:54:40.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C00012 Education level USA type EduLvlUSATyp Highest grade or level of school participant/subject has completed or the highest degree received Highest grade or level of school participant/subject has completed or the highest degree received Level of education Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational/technical/vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational/technical/vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Alphanumeric

choose one

Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

3134878
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 Marital/Partner status Never married;Married;Domestic partnership;Divorced;Separated;Widowed Never married;Married;Domestic partnership;Divorced;Separated;Widowed Alphanumeric

Choose one. Response is obtained by report of the participant/subject or a reliable proxy.

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 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2188083
C19267 Occupation category type OccupationCategoryTyp The type of occupation indicated by the participant/subject. The type of occupation indicated by the participant/subject. Type of primary occupation (paid employment) (ISCO 08, Major groups) Armed forces occupation;Clerical support workers;Craft and related trades workers;Elementary occupations;Managers and officials;N/A;Other, specify;Plant and machine operators and assemblers;Professionals;Service and sales workers;Skilled agricultural, forestry and fishery workers;Technicians and associate professionals;Unknown;Not reported Armed forces occupation (officers, service personnel);Clerical support workers (secretary, clerk, office manager, book keeper);Craft and related trades workers (e.g. motor mechanic, printer, tool and die makers, electrician);Elementary occupations (laborer, porter, unskilled workers);Managers and officials;N/A;Other, specify;Plant and machine operators and assemblers;Professionals (typically requiring longer tertiary education);Service and sales workers (waiters, caretaker, shop assistants, insurance agents, sales manager);Skilled agricultural, forestry and fishery workers;Technicians and associate professionals (typically requiring a Bachelor degree or equivilent);Unknown;Not reported Alphanumeric

ISCO 08, Major groups
This variable is according to the International Standard Classification of Occupations (ISCO) developed by the International Labor Organization (ILO) (ISCO-08 http://www.ilo.org/public/english/bureau/stat/isco/isco08/). It can in most cases be adjusted to national standards (including the US Standard Occupational Classification - SOC). The idea behind the ISCO classification is to differentiate skill level/skill specialization required to perform the task of an occupation in a competent way. Unless the classification is intuitive, it has to be accompanied by a 1-2 page manual.

International Standard Classification of Occupations (ISCO) developed by the International Labor Organization (ILO) (ISCO-08 http://www.ilo.org/public/english/bureau/stat/isco/isco08/) Adult;Pediatric Supplemental 1.00 2014-06-06 10:15:14.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00013 Education level primary caregiver USA type EduLvlPrimCaregiverUSATyp Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received Highest grade or level of school the participant's/subject's primary caregiver has completed or the highest degree he/she has received Primary caregiver's level of education Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Never attended/Kindergarten only;1st Grade;2nd Grade;3rd Grade;4th Grade;5th Grade;6th Grade;7th Grade;8th Grade;9th Grade;10th Grade;11th Grade;12th Grade, no diploma;High school graduate;GED or equivalent;Some college, no degree;Associate degree: occupational, technical, or vocational program;Associate degree: academic program;Bachelor's degree (e.g., BA, AB, BS, BBA);Master's degree (e.g., MA, MS, MEng, MEd, MBA);Professional school degree (e.g., MD, DDS, DVM, JD);Doctoral degree (e.g., PhD, EdD);Unknown Alphanumeric

What is the highest level of education the participant's/subject's primary caregiver has completed or the highest degree obtained?

Pediatric Supplemental-Highly Recommended 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C13485 Household member total count HouseMembTotCt The total number of members in the participant's household. The total number of members in the participant's household. How many members are there in your household (including yourself)? Numeric Values

Write in number

Lipton RL, et al. Prevalence and burden of Migraine in the United States: Data from the American Migraine Study II. Headache. 2001; 41: 646-657. Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Free-Form Entry

0 20
C19279 Citizen country indicator CitizenCountryInd The indicator for whether participant is a citizen of country. The indicator for whether participant is a citizen of country. Are you a citizen of No;Yes;Unknown No;Yes;Unknown Alphanumeric

(country)

Adult;Pediatric Exploratory 1.00 2014-06-06 10:43:21.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00015 Education year count EduYrCt Number of years of education completed (age 5 and beyond) Number of years of education completed (age 5 and beyond) Years of education Numeric Values

For years completed, after the age of 5, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. Recommend collection at least on date of TBI.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-22 16:57:17.79 Demographics Demographics Participant Characteristics

Free-Form Entry

0 30 year 3134878
C17396 Sex genotype type SexGenotypTyp The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement. Sex chromosomes of the participant/subject based upon genotyping Genotypic sex XX;XY;XXX;XYY;Other, specify;Unknown;Unspecified XX;XY;XXX;XYY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex Alphanumeric Pediatric Supplemental 3.10 2018-07-26 00:00:00.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

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 clothing. How do you get along with your current household income 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;Pediatric Exploratory 1.00 2014-06-06 11:03:24.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00020 Ethnicity USA category EthnUSACat Category of ethnicity the participant/subject most closely identifies with Category of ethnicity the participant/subject most closely identifies with 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 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
C18386 Less three years age value LessThreYrAgeVal Number of months from zero to thirty-six months of age. Number of months from zero to thirty-six months of age. Age if less than 3 years of age (in months) Numeric Values Pediatric Core 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Free-Form Entry

0 36 month
C21647 Hand preference pre-injury type HandPrefPreInjTyp Hand which the participant/subject used predominantly, not necessarily the hand he/she wrote with exclusively prior to injury Hand which the participant/subject used predominantly, not necessarily the hand he/she wrote with exclusively prior to injury Pre-injury hand preference: Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

(Hand participant/subject uses predominantly, not he/she wrote with exclusively)

Pediatric Supplemental 1.00 2015-12-23 14:10:28.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

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 exclusively. Current hand preference: Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

(Hand participant/subject uses predominantly, not necessarily he/she writes with exclusively)

Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2180147
C18732 Language primary other text LangPrimryOTH The free-text field related to 'Language primary text' specifying other text. Text for the language the participant/subject speaks most often The free-text field related to 'Language primary text' specifying other text. Text for the language the participant/subject speaks most often Other, specify ISO 639-2 code Alphanumeric Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C21660 Caregiver marital or partner status CargvrMartlPartnerStatus Status of participant/subject's caregiver's current domestic relationship, whether marital or partnered Status of participant/subject's caregiver's current domestic relationship, whether marital or partnered Caregiver marital status Never married;Married;Domestic partnership;Divorced;Separated;Widowed Never married;Married;Domestic partnership;Divorced;Separated;Widowed Alphanumeric

(choose one):

Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00024 Language primary ISO code LangPrimryCode Code (ISO 639-2) for the language the participant/subject speaks most often Code (ISO 639-2) for the language the participant/subject speaks most often Primary language Alphanumeric

ISO 639-2 code

Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C18751 Sex participant or subject genotype other text SexSubjectGenotypOTH The free-text field related to 'Sex participant or subject genotype type' specifying other text. The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement. The free-text field related to 'Sex participant or subject genotype type' specifying other text. Sex chromosomes of the participant/subject based upon genotyping Other, Specify Alphanumeric Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

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 eng;spa;sgn;chi;fre;ger;Other, specify English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify Alphanumeric Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C19257 Residence area type ResidenceAreaTyp Type describing the participant's/subject's current location of residence Type describing the participant's/subject's current location of residence Area 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 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

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 Birth country name and corresponding ISO 3166 1 alpha 2 code AF;AX;AL;DZ;AS;AD;AO;AI;AQ;AG;AR;AM;AW;AU;AT;AZ;BS;BH;BD;BB;BY;BE;BZ;BJ;BM;BT;BO;BQ;BA;BW;BV;BR;IO;BN;BG;BF;BI;KH;CM;CA;CV;KY;CF;TD;CL;CN;CX;CC;CO;KM;CG;CD;CK;CR;CI;HR;CU;CW;CY;CZ;DK;DJ;DM;DO;EC;EG;SV;GQ;ER;EE;ET;FK;FO;FJ;FI;FR;GF;PF;TF;GA;GM;GE;DE;GH;GI;GR;GL;GD;GP;GU;GT;GG;GN;GW;GY;HT;HM;VA;HN;HK;HU;IS;IN;ID;IR;IQ;IE;IM;IL;IT;JM;JP;JE;JO;KZ;KE;KI;KP;KR;KW;KG;LA;LV;LB;LS;LR;LY;LI;LT;LU;MO;MK;MG;MW;MY;MV;ML;MT;MH;MQ;MR;MU;YT;MX;FM;MD;MC;MN;ME;MS;MA;MZ;MM;NA;NR;NP;NL;NC;NZ;NI;NE;NG;NU;NF;MP;NO;OM;PK;PW;PS;PA;PG;PY;PE;PH;PN;PL;PT;PR;QA;RE;RO;RU;RW;BL;SH;KN;LC;MF;PM;VC;WS;SM;ST;SA;SN;RS;SC;SL;SG;SX;SK;SI;SB;SO;ZA;GS;SS;ES;LK;SD;SR;SJ;SZ;SE;CH;SY;TW;TJ;TZ;TH;TL;TG;TK;TO;TT;TN;TR;TM;TC;TV;UG;UA;AE;GB;US;UM;UY;UZ;VU;VE;VN;VG;VI;WF;EH;YE;ZM;ZW AFGHANISTAN;ALAND ISLANDS;ALBANIA;ALGERIA;AMERICAN SAMOA;ANDORRA;ANGOLA;ANGUILLA;ANTARCTICA;ANTIGUA AND BARBUDA;ARGENTINA;ARMENIA;ARUBA;AUSTRALIA;AUSTRIA;AZERBAIJAN;BAHAMAS;BAHRAIN;BANGLADESH;BARBADOS;BELARUS;BELGIUM;BELIZE;BENIN;BERMUDA;BHUTAN;BOLIVIA, PLURINATIONAL STATE OF;BONAIRE, SINT EUSTATIUS AND SABA;BOSNIA AND HERZEGOVINA;BOTSWANA;BOUVET ISLAND;BRAZIL;BRITISH INDIAN OCEAN TERRITORY;BRUNEI DARUSSALAM;BULGARIA;BURKINA FASO;BURUNDI;CAMBODIA;CAMEROON;CANADA;CAPE VERDE;CAYMAN ISLANDS;CENTRAL AFRICAN REPUBLIC;CHAD;CHILE;CHINA;CHRISTMAS ISLAND;COCOS (KEELING) ISLANDS;COLOMBIA;COMOROS;CONGO;CONGO, THE DEMOCRATIC REPUBLIC OF THE;COOK ISLANDS;COSTA RICA;COTE D'IVOIRE;CROATIA;CUBA;CURACAO;CYPRUS;CZECH REPUBLIC;DENMARK;DJIBOUTI;DOMINICA;DOMINICAN REPUBLIC;ECUADOR;EGYPT;EL SALVADOR;EQUATORIAL GUINEA;ER;ESTONIA;ETHIOPIA;FALKLAND ISLANDS (MALVINAS);FAROE ISLANDS;FIJI;FINLAND;FRANCE;FRENCH GUIANA;FRENCH POLYNESIA;FRENCH SOUTHERN TERRITORIES;GABON;GAMBIA;GEORGIA;GERMANY;GHANA;GIBRALTAR;GREECE;GREENLAND;GRENADA;GUADELOUPE;GUAM;GUATEMALA;GUERNSEY;GUINEA;GUINEA-BISSAU;GUYANA;HAITI;HEARD ISLAND AND MCDONALD ISLANDS;HOLY SEE (VATICAN CITY STATE);HONDURAS;HONG KONG;HUNGARY;ICELAND;INDIA;INDONESIA;IRAN, ISLAMIC REPUBLIC OF;IRAQ;IRELAND;ISLE OF MAN;ISRAEL;ITALY;JAMAICA;JAPAN;JERSEY;JORDAN;KAZAKHSTAN;KENYA;KIRIBATI;KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF;KOREA, REPUBLIC OF;KUWAIT;KYRGYZSTAN;LAO PEOPLE'S DEMOCRATIC REPUBLIC;LATVIA;LEBANON;LESOTHO;LIBERIA;LIBYA;LIECHTENSTEIN;LITHUANIA;LUXEMBOURG;MACAO;MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF;MADAGASCAR;MALAWI;MALAYSIA;MALDIVES;MALI;MALTA;MARSHALL ISLANDS;MARTINIQUE;MAURITANIA;MAURITIUS;MAYOTTE;MEXICO;MICRONESIA, FEDERATED STATES OF;MOLDOVA, REPUBLIC OF;MONACO;MONGOLIA;MONTENEGRO;MONTSERRAT;MOROCCO;MOZAMBIQUE;MYANMAR;NAMIBIA;NAURU;NEPAL;NETHERLANDS;NEW CALEDONIA;NEW ZEALAND;NICARAGUA;NIGER;NIGERIA;NIUE;NORFOLK ISLAND;NORTHERN MARIANA ISLANDS;NORWAY;OMAN;PAKISTAN;PALAU;PALESTINIAN TERRITORY, OCCUPIED;PANAMA;PAPUA NEW GUINEA;PARAGUAY;PERU;PHILIPPINES;PITCAIRN;POLAND;PORTUGAL;PUERTO RICO;QATAR;REUNION;ROMANIA;RUSSIAN FEDERATION;RWANDA;SAINT BARTHELEMY;SAINT HELENA, ASCENSION AND TRISTAN DA CUNHA;SAINT KITTS AND NEVIS;SAINT LUCIA;SAINT MARTIN (FRENCH PART);SAINT PIERRE AND MIQUELON;SAINT VINCENT AND THE GRENADINES;SAMOA;SAN MARINO;SAO TOME AND PRINCIPE;SAUDI ARABIA;SENEGAL;SERBIA;SEYCHELLES;SIERRA LEONE;SINGAPORE;SINT MAARTEN (DUTCH PART);SLOVAKIA;SLOVENIA;SOLOMON ISLANDS;SOMALIA;SOUTH AFRICA;SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS;SOUTH SUDAN;SPAIN;SRI LANKA;SUDAN;SURINAME;SVALBARD AND JAN MAYEN;SWAZILAND;SWEDEN;SWITZERLAND;SYRIAN ARAB REPUBLIC;TAIWAN, PROVINCE OF CHINA;TAJIKISTAN;TANZANIA, UNITED REPUBLIC OF;THAILAND;TIMOR-LESTE;TOGO;TOKELAU;TONGA;TRINIDAD AND TOBAGO;TUNISIA;TURKEY;TURKMENISTAN;TURKS AND CAICOS ISLANDS;TUVALU;UGANDA;UKRAINE;UNITED ARAB EMIRATES;UNITED KINGDOM;UNITED STATES;UNITED STATES MINOR OUTLYING ISLANDS;URUGUAY;UZBEKISTAN;VANUATU;VENEZUELA, BOLIVARIAN REPUBLIC OF;VIET NAM;VIRGIN ISLANDS, BRITISH;VIRGIN ISLANDS, U.S.;WALLIS AND FUTUNA;WESTERN SAHARA;YEMEN;ZAMBIA;ZIMBABWE 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.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Exploratory 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00030 Race USA category RaceUSACat The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories. The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories. Race 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

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.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of 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 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
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 status. Primary Occupation 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;Pediatric Supplemental 1.00 2014-06-06 08:50:45.0 Demographics 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 Country: Alphanumeric

include country if outside of US

Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C00035 Gender type GenderTyp Self-reported gender of the participant/subject. Self-reported gender of the participant/subject.. Gender Alphanumeric

Choose one. Response is obtained by report of the participant/subject or caretaker.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
C19259 Occupation primary other status text OccupationPrimaryOthrStatusTxt The free-text field to capture other status indicating the participant's/subject's current primary occupational status. The free-text field to capture other status indicating the participant's/subject's current primary occupational status. Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-06 09:12:40.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

CSV