CDE Detailed Report
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 24 of 24
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 |
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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 | Alphanumeric |
Choose one. 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 | 1.00 | 2014-05-27 13:34:46.0 | Demographics | 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 | Primary language (ISO 639-2 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 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 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C19037 | Birth order other text | BirthOrderOTH | The free-text field related to 'Birth order number' specifying other text. Number of the birth order or the sequence of the participant's/subject's birth in the family group | The free-text field related to 'Birth order number' specifying other text. Number of the birth order or the sequence of the participant's/subject's birth in the family group | Other, specify | Alphanumeric |
If the participant/subject is a multiple birth, select the birth order. This element is recommended for pediatric headache studies. |
No references available | Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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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 those with which the participant/ subject identifies. |
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 | 3.1 | 10/16/2024 8:51:18 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | |||||||
C19500 | Assessment performed date | AssessmentPerformedDate | The date of assessment of the examination being performed | The date of assessment of the examination being performed | Date of Interview | Date or Date & Time | Adult;Pediatric | Core | 1.00 | 2014-06-18 08:10:12.0 | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
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C00032 | Race USA paternal category | RaceUSAPatrnlCat | Race(s) the participant's father most closely identifies with | Race(s) the participant's father most closely identifies with | Paternal 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 those with which the father identifies. This element is recommended for pediatric headache studies. |
'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) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:24 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182269;2192199, 3182197 | |||||||
C55577 | Sex at Birth Type | SexBirthTyp | Self-reported sex of the participant/subject at birth | Self-reported sex of the participant/subject at birt | Sex at birth | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2200604 | |||||||||
C00004 | Birth country ISO code | BirthCntryISOCode | Code (ISO 3166-1 alpha-2 code) for country where the participant was born | Code (ISO 3166-1 alpha-2 code) for country where the participant was born | Country of birth | 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 | Supplemental | 3.1 | 10/16/2024 8:51:21 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C00033 | Race USA maternal category | RaceUSAMatrnlCat | Race(s) the participant's mother most closely identifies with | Race(s) the participant's mother most closely identifies with | Maternal 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 those with which the mother identifies. This element is recommended for pediatric headache studies |
'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) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:23 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182197;2192199 | |||||||
C55578 | Sexual orientation type | SexualOrientTyp | Self-reported sexual orientation of the participant/subject | Self-reported sexual orientation of the participant/subject | Sexual orientation | Bisexual;Gay/Lesbian;Heterosexual;Not reported;Other;Unknown | Bisexual;Gay/Lesbian;Heterosexual;Not reported;Other;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
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C00005 | Birth country name | BirthCntryName | Name for country where the participant was born | Name for country where the participant was born | Country of birth | 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 | Supplemental | 3.1 | 10/16/2024 8:51:20 AM | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject | Self-reported gender of the participant/subjec | Gender | Alphanumeric |
Choose one. Additionally, studies can add the following options for more specific choices: Male to Female transgender; Female to Male transgender. |
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 | |||||||||
C55904 | Sex at birth other text | SexBirthOthrTxt | Text describing another variety of the subject's self-proclaimed sex at his/her birth | Text describing another variety of the subject's self-proclaimed sex at his/her birt | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2017-06-02 11:42:14.0 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C00007 | Birth date | BirthDate | Date (and time, if applicable and known) the participant was born | Date (and time, if applicable and known) the participant was born | Birth 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.). |
No references available | Adult;Pediatric | Core | 3.1 | 10/16/2024 8:51:14 AM | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
793 | |||||||||
C08088 | Age value unit of measure | AgeValUoM | Unit of measure used to initially record the age value | Unit of measure used to initially record the age value | Age | Months;years | Months;years | Alphanumeric |
It is recommended that age be calcuated from date of birth and the study enrollment date. However, if age needs to be collectd (e.g., full date of birth is not allowed to be collected) then it should be recorded in months and years. This eemen s recommended as Core for pediatric headahce studies. |
Pediatric | Supplemental | 3.00 | 2013-07-22 09:34:41.527 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C00008 | Age value | AgeVal | Value for participant's age, calculated as elapsed time since the birth of the participant | Value for participant's age, calculated as elapsed time since the birth of the participant | Age | Numeric Values |
It is recommended that age be calculated from date of birth and the study enrollment date. However, if age needs to be collected (e.g., full date of birth is not allowed to be collected) then it should be recorded in months and years. This element is strongly recommended for pediatric headache studies. |
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 | 3.10 | 2024-02-29 15:47:28.0 | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 1800 | month | |||||||
C10677 | ZIP partial code | ZIPPartialCode | First three digits of the zip code where the participant/subject currently lives | First three digits of the zip code where the participant/subject currently live | First 3 digits of zip code | Alphanumeric |
Answering this question is optional |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C00020 | Ethnicity USA category | EthnUSACat | Category of ethnicity the participant most closely identifies with | Category of ethnicity the participant 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 only one with which the participant/ subject most closely identifies. |
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 | 3.1 | 10/16/2024 8:51:17 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
C14124 | Social security number | SocialSecurityNum | A nine-digit number issued to U.S. citizens, permanent residents, and temporary (working) residents under section 205(c)(2) of the Social Security Act, codified as 42 U.S.C. § 405(c)(2). The number is issued to an individual by the Social Security Administration, an independent agency of the United States government | A nine-digit number issued to U.S. citizens, permanent residents, and temporary (working) residents under section 205(c)(2) of the Social Security Act, codified as 42 U.S.C. § 405(c)(2). The number is issued to an individual by the Social Security Administration, an independent agency of the United States governmen | Social security number | Numeric Values |
The preferred format for recording SSN is _ _ _ - _ _ - _ _ _ _. Providing this information is entirely voluntary and the participant/ subject may refuse. This information must be kept confidential according to the Privacy Act of 1974, and must only be used for research purposes. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
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C00021 | Ethnicity USA paternal category | EthnUSAPatrnlCat | Ethnicity the participant's father most closely identifies with | Ethnicity the participant's father most closely identifies with | Paternal ethnicity | Unknown;Not reported;Hispanic or Latino;Not Hispanic or Latino | Unknown;Not reported;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. | Alphanumeric |
Choose only one with which the father most closely identifies. This element is recommended for pediatric headache studies. |
'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) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:24 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2182266;3182162;2192217 | |||||||
C15984 | Birth order number | BirthOrderNum | Number of the birth order or the sequence of the participant's/subject's birth in the family group | Number of the birth order or the sequence of the participant's/subject's birth in the family group | Birth order? | 1st;2nd;3rd;4th;5th;Other, specify | 1st;2nd;3rd;4th;5th;Other, specify | Alphanumeric |
If the participant/subject is a multiple birth, select the birth order. This element is recommended for pediatric headache studies. |
No references available | Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C00022 | Ethnicity USA maternal category | EthnUSAMatrnlCat | Ethnicity the participant's mother most closely identifies with | Ethnicity the participant's mother most closely identifies with | Maternal ethnicity | Unknown;Not reported;Hispanic or Latino;Not Hispanic or Latino | Unknown;Not reported;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. | Alphanumeric |
Choose only one with which the mother most closely identifies. This element is recommended for pediatric headache studies |
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) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:22 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217;3182162 | |||||||
C15985 | Multiple birth indicator | MultipleBirthInd | Indicates whether the participant/subject was a part of a multiple live birth | Indicates whether the participant/subject was a part of a multiple live birth | Part of a multiple birth? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one |
No references available | Pediatric | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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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 | Other, specify ISO 639-2 code | Alphanumeric |
Choose one. 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 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |