CDE Detailed Report

Disease: Traumatic Brain Injury
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 20 of 20
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 / 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 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.).

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
C00031 Race expanded category RaceCat Category of race(s) or region(s) the participant/subject most closely identifies with Category of race(s) or region(s) the participant/subject most closely identifies with Race expanded category Not reported;Other;Unknown;Black African American;Black African;Black Afro Caribbean;South/Central American Indian;North American Indian;Alaskan Native;Inuit;South Asian;Far Eastern Asian;Western Asian;White North American;White South American;White European;White Middle Eastern;White African;White Australian;Hawaiian;Pacific Islander Not reported;Other;Unknown;Black African American (for OMB purposes, this value is considered to be part of Black or African-American);Black African (for OMB purposes, this value is considered to be part of Black or African-American);Black Afro Caribbean (for OMB purposes, this value is considered to be part of Black or African-American);South/Central American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);North American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Alaskan Native (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Inuit (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);Far Eastern Asian (e.g., China, Japan, Korea, etc.) (for OMB purposes, this value is considered to be part of Asian);Western Asian (e.g., Pakistan, Iraq, Iran) (for OMB purposes, this value is considered to be part of Asian);White North American (for OMB purposes, this value is considered to be part of White);White South American (for OMB purposes, this value is considered to be part of White);White European (for OMB purposes, this value is considered to be part of White);White Middle Eastern (for OMB purposes, this value is considered to be part of White);White African (for OMB purposes, this value is considered to be part of White);White Australian (for OMB purposes, this value is considered to be part of White);Hawaiian (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander) Alphanumeric

Choose all that apply.

Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. Adult;Pediatric Core 3.00 2013-07-22 16:57:17.79 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/subjec 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 Basic 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Free-Form Entry

0 1800 month
C00035 Gender type GenderTyp Self-reported gender of the participant/subject Self-reported gender of the participant/subjec Gender Alphanumeric

Choose one

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 - http://grants.nih.gov/grants/funding/women_min/women_min.htm Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. Mushkudiani et al J Neurotrauma 2007;24:329-37. Do women fare worse: a meta-analysis of gender differences in traumatic brain injury outcome. Farace et al, J Neurosurg 2000;93:539-545. Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
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

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 Core 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) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
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 Sex XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex Alphanumeric

No instructions available

No references available Adult;Pediatric Core 3.10 2018-07-26 00:00:00.0 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 exclusivel Hand preference type Left hand;Right hand;Both hands;Unknown Left hand;Right hand;Both hands;Unknown Alphanumeric

Choose one.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2180147
C18385 Birth time BrthTm Time the subject was born Time the subject was born Birth time Alphanumeric

These elements may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics 255

Free-Form Entry

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

Free-Form Entry

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 ag If less than 3 years of 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 Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Free-Form Entry

0 36 month
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 Language primary text eng;spa;sgn;chi;fre;ger;Other, specify English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify Alphanumeric

Text for participant's/subject's primary language. 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 Basic 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

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

Text for participant's/subject's primary language. 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 Basic 1.00 2014-05-27 13:34:46.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C00026 Language spoken Fluent text LangSpokeFluentTxt Text for each language that the participant/subject speaks fluently Text for each language that the participant/subject speaks fluently Language spoken fluently text and corresponding ISO 639-2 code Alphanumeric

Text for all languages participant/subject speaks fluently. 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

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

No instructions available

No references available Adult;Pediatric Core 1.00 2014-05-27 13:34:46.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C00027 Language written Fluent text LangWrtnFlntlyTxt Text for each language that the participant/subject writes fluently Text for each language that the participant/subject writes fluently Language written fluently text and corresponding ISO 639-2 code Alphanumeric

Text for all languages participant/subject writes fluently. 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

C00028 Language spoken fluent ISO code LangSpokeFluentISOCode Code (ISO 639-2)for each language that the participant/subject speaks fluently Code (ISO 639-2)for each language that the participant/subject speaks fluently Language spoken fluently text and corresponding ISO 639-2 code English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic;Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi) English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic (ara);Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi) Alphanumeric

Choose all that apply. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes.

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

Multiple Pre-Defined Values 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 Supplemental 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00029 Language written fluent ISO code LangWrtnFlntlyTxtISOCode Code (ISO 639-2) for each language that the participant/subject writes fluently Code (ISO 639-2) for each language that the participant/subject writes fluently Language written fluently text and corresponding ISO 639-2 code Alphanumeric

Choose all that apply. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes.

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

C00005 Birth country name BirthCntryName Name for country where the participant/subject was born Name for country where the participant/subject was born Birth country name and corresponding ISO 3166 1 alpha 2 code 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

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 category 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.

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 Core 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) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
CSV