CDE Detailed Report

Disease: Headache
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
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

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 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 3.00 2013-07-25 08:54:08.2 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

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

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 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 3.00 2013-08-28 16:08:00.453 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

C00021 Ethnicity USA paternal category EthnUSAPatrnlCat Ethnicity the participant/subject's father most closely identifies with Ethnicity the participant/subject'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 3.00 2013-07-25 08:54:08.2 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

C00022 Ethnicity USA maternal category EthnUSAMatrnlCat Ethnicity the participant/subject's mother most closely identifies with Ethnicity the participant/subject'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 3.00 2013-07-25 08:54:08.2 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

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

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

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

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

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 categori 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 3.00 2013-07-25 08:54:08.2 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

C00032 Race USA paternal category RaceUSAPatrnlCat Race(s) the participant/subject's father most closely identifies with Race(s) the participant/subject'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 3.00 2013-07-25 08:54:08.2 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/subject was born Code (ISO 3166-1 alpha-2 code) for country where the participant/subject 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 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00033 Race USA maternal category RaceUSAMatrnlCat Race(s) the participant/subject's mother most closely identifies with Race(s) the participant/subject'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 3.00 2013-07-25 08:54:08.2 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

C00005 Birth country name BirthCntryName Name for country where the participant/subject was born Name for country where the participant/subject 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 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics 255

Free-Form Entry

CSV