CDE Detailed Report
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 17 of 17
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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C00005 | Birth country name | BirthCntryName | Name for country where the participant was born | Name for country where the participant was born | In what country were you born? (A country outside the United States) | Alphanumeric |
A country outside the United States. |
ScHARe CDEs: https://cde.nlm.nih.gov/cde/search?selectedOrg=ScHARe&nihEndorsed=true | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:20 AM | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C12611 | Birth location state name | BirthLocStateName | Name of the state/province/similar political division in which participant was born | Name of the state/province/similar political division in which participant was born | Where were you born? (In the United States, including U.S. Territories--Puerto Rico, Guam, U.S. Virgin Islands, American Samoa and Northern Mariana Islands). | AL;AK;AZ;AR;CA;CO;CT;DC;DE;FL;GA;HI;ID;IL;IN;IA;KS;KY;LA;ME;MD;MA;MI;MN;MS;MO;MT;NE;NV;NH;NJ;NM;NY;NC;ND;OH;OK;OR;PA;RI;SC;SD;TN;TX;UT;VT;VA;WA;WV;WI;WY;Other, specify | AL;AK;AZ;AR;CA;CO;CT;DC;DE;FL;GA;HI;ID;IL;IN;IA;KS;KY;LA;ME;MD;MA;MI;MN;MS;MO;MT;NE;NV;NH;NJ;NM;NY;NC;ND;OH;OK;OR;PA;RI;SC;SD;TN;TX;UT;VT;VA;WA;WV;WI;WY;Other, specify | Alphanumeric |
If you were born outside the US, skip to the next question. |
ScHARe CDEs: https://cde.nlm.nih.gov/cde/search?selectedOrg=ScHARe&nihEndorsed=true | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:19 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C18385 | Birth time | BrthTime | Time the participant was born | Time the participant was born | Time | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://www.iso.org/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.) and in an unambiguous format acceptable to the study database like DD-MMM-YYYY. When date/time data are prepared for aggregation or sharing, they should be converted to the format specified by ISO 8601; YYYY-MM-DD T:hh:mm:ss (https://www.iso.org/iso-8601-date-and-time-format.html). 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 - https://www.iso.org/home.html | Pediatric | Supplemental | 4 | 10/16/2024 8:51:25 AM | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
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C18863 | Birth location state other text | BirthLocStateOTH | The free-text field related to 'Birth location state name', specifying other text. Name of the state/province/similar political division in which participant was born | The free-text field related to 'Birth location state name', specifying other text. Name of the state/province/similar political division in which participant was born | Other, specify | Alphanumeric |
If you were born outside the US, skip to the next question. |
ScHARe CDEs: https://cde.nlm.nih.gov/cde/search?selectedOrg=ScHARe&nihEndorsed=true | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:19 AM | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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C22780 | Date time clock type | DateTimeClockTyp | Type of clock used to record date and time | Type of clock used to record date and time | Time | am;PM;24-hour clock | am;PM;24-hour clock | Alphanumeric |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://www.iso.org/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.) and in an unambiguous format acceptable to the study database like DD-MMM-YYYY. When date/time data are prepared for aggregation or sharing, they should be converted to the format specified by ISO 8601; YYYY-MM-DD T:hh:mm:ss (https://www.iso.org/iso-8601-date-and-time-format.html). 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 - https://www.iso.org/home.html | Pediatric | Supplemental | 1.1 | 10/16/2024 8:50:25 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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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 | In what country were you born? (A country outside the United States) | 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 |
A country outside the United States. |
ScHARe CDEs: https://cde.nlm.nih.gov/cde/search?selectedOrg=ScHARe&nihEndorsed=true | 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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C58676 | Birth sex assigned type | BirthSexAssignTyp | Self-reported phenotypic sex of participant, assigned at birth | Self-reported phenotypic sex of participant, assigned at birth | Sex assigned at birth | Male;Female;Intersex;Unknown;Other, specify | Male;Female;Intersex;Unknown;Other, specify | Alphanumeric | Adult;Pediatric | Core | 1.1 | 10/16/2024 8:51:15 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C58677 | Gender identity type | GenderIdTyp | Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | Gender identity | Male;Female;Unknown;Other, specify | Male;Female;Unknown;Other, specify | Alphanumeric | Adult;Pediatric | Core | 1.1 | 10/16/2024 8:51:16 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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C58780 | Birth sex assigned type other text | BirthSexAssignTypOTH | The free-text field related to 'Birth sex assigned type', specifying other text. Self-reported phenotypic sex of participant, assigned at birth | The free-text field related to 'Birth sex assigned type', specifying other text. Self-reported phenotypic sex of participant, assigned at birth | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:51:15 AM | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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C58781 | Gender identity type other text | GenderIdTypOTH | The free-text field related to 'Gender identity type', specifying other text. Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | The free-text field related to 'Gender identity type', specifying other text. Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:51:17 AM | Demographics | Demographics | Participant Characteristics | 4000 |
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 one. Response as reported by the participant 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. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Adult;Pediatric | Core | 3.1 | 10/16/2024 8:51:17 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
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 that the participant's father most closely identifies with |
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. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:24 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2182266;3182162;2192217 | |||||||
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 that the participant's mother most closely identifies with |
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. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:22 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217;3182162 | |||||||
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 as reported by the participant 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 Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Adult;Pediatric | Core | 3.1 | 10/16/2024 8:51:18 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | |||||||
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 racial categories that the participant's father identifies with |
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. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:24 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182269;2192199, 3182197 | |||||||
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 racial categories that the participant's mother identifies with |
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. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:23 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182197;2192199 | |||||||
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 | 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 (https://www.iso.org/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.) and in an unambiguous format acceptable to the study database like DD-MMM-YYYY. When date/time data are prepared for aggregation or sharing, they should be converted to the format specified by ISO 8601; YYYY-MM-DD T:hh:mm:ss (https://www.iso.org/iso-8601-date-and-time-format.html). 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 - https://www.iso.org/home.html 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 | 3.1 | 10/16/2024 8:51:14 AM | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
793 |