CDE Detailed Report

Disease: Stroke
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 22 of 22
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C58676 Birth sex assigned type BirthSexAssignTyp Self-reported phenotypic sex of participant/subject, assigned at birth. Self-reported phenotypic sex of participant/subject, assigned at birth. Sex assigned at birth Male;Female;Intersex;Unknown;Other, specify Male;Female;Intersex;Unknown;Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Core 1.00 2020-01-07 14:00:16.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C58677 Gender identity type GenderIdTyp Gender identity self-identified by the subject/participant. Gender type may or may not match sex assigned at birth. Gender identity self-identified by the subject/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

No instructions available

No references available Adult;Pediatric Core 1.00 2020-01-07 14:20:24.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C58780 Birth sex assigned type other text BirthSexAssignTypOTH The free-text field related to 'Birth sex assigned type', specifying other text. The free-text field related to 'Birth sex assigned type', specifying other text. Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-05-12 10:47:54.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C58781 Gender identity type other text GenderIdTypOTH The free-text field related to 'Gender identity type', specifying other text. The free-text field related to 'Gender identity type', specifying other text. Other, specify Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1.00 2020-05-12 10:50:12.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C58782 Race expanded maternal category RaceExpMatrnlCat Category of race(s) or region(s) the participant/subject's mother most closely identifies with Category of race(s) or region(s) the participant/subject's mother most closely identifies with Maternal race expanded category South Asian;Far Eastern Asian;Western Asian;Black African American;Black African;Black Afro Carribean;South/Central American Indian;North American Indian;Alaskan Native;Inuit 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);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 Carribean (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) Alphanumeric

This element is recommended for pediatric stroke studies.
Choose all those with which the parent identifies. Race should be self-reported.

No references available Pediatric Exploratory 1.00 2020-05-12 10:51:54.0 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C58783 Race expanded paternal category RaceExpPatrnlCat Category of race(s) or region(s) the participant/subject's father most closely identifies with Category of race(s) or region(s) the participant/subject's father most closely identifies with Paternal race expanded category South Asian;Far Eastern Asian;Western Asian;Black African American;Black African;Black Afro Carribean;South/Central American Indian;North American Indian;Alaskan Native;Inuit 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);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 Carribean (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) Alphanumeric

This element is recommended for pediatric stroke studies.
Choose all those with which the parent identifies. Race should be self-reported.

No references available Adult;Pediatric Exploratory 1.00 2020-05-12 12:48:50.0 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

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 Black African American;Black African;Black Afro Carribean;South/Central American Indian;North American Indian;Alaskan Native;Inuit;South Asian;Far Eastern Asian;Western Asian 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 Carribean (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) Alphanumeric

No instructions available

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

Multiple Pre-Defined Values Selected

C52535 Ethnicity pertinent intracranial aneurysm type EthnPertinentUIAtype Ethnicity type pertinent to unruptured intracranial aneurysms the participant/subject most closely identifies with Ethnicity type pertinent to unruptured intracranial aneurysms the participant/subject most closely identifies with Ethnicity pertinent to intracranial aneurysm Japanese;Finnish;Eastern Asian;European;Persian;Arabic;Southeast Asian;South Asian;Pacific Islander;American Indian Japanese;Finnish;Eastern Asian;European;Persian;Arabic (ara);Southeast Asian;South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);American Indian Alphanumeric

No instructions available

No references available Adult;Pediatric Exploratory 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
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(s) fully fluent English (eng);Spanish (spa);American Sign Language (sgn);Chinese languages (Chi);French/Creole (cpf);German (ger);Other specify English (eng);Spanish (spa);American Sign Language (sgn);Chinese languages (Chi);French/Creole (cpf);German (ger);Other specify 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

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. Race should be reported by the subject or caretaker.

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, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
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

This element is recommended for pediatric stroke studies. Choose all those with which the parent identifies. Race should be self-reported.

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

Multiple Pre-Defined Values Selected

3182269;2192199, 3182197
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

This element is recommended for pediatric stroke studies. Choose all those with which the parent identifies. Race should be self-reported.

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

Multiple Pre-Defined Values Selected

3182197;2192199
C10676 Country of residence code CntryResdnceISOCode Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Country US;CA;GB;MX;AU;Other, specify;RU;CN;IN;JP;DE;FR;Other European;Other Asian;FI USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify;Russia (RU);China (CN);India (IN);Japan (JP);Germany (DE);France (FR);Other European;Other Asian;Finland (FI) Alphanumeric

Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Exploratory 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

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 lives. Zip/Postal Code Alphanumeric

This is an optional field, if this information is not provided enter 000.

NINDS Genetics Repository, Required Clinical Data Elements for subjects with Cerebrovascular Disease - http://ccr.coriell.org/Sections/Collections/NINDS/Cerebrovascular.aspx?PgId=190&coll=ND Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 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 Date of birth Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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. ISO 8601http://www.iso.org/iso/home.html Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Free-Form Entry

793
C14123 Country of residence name CntryResdnceName Country where the participant/subject currently lives. Country where the participant/subject currently lives. Country of residence Alphanumeric

No instructions available

No references available Adult;Pediatric Exploratory 3.00 2013-06-21 00:00:00.0 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. Ethnicity should be reported by the subject or caretaker.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 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, October 2016 - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials) 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). Social security number Numeric Values

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. The preferred format for recording SSN is _ _ _ - _ _ - _ _ _ _

Framingham Heart Study 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

This element is recommended for pediatric stroke studies. Choose only one with which the parent most closely identifies. Ethnicity should be self-reported.

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
C18806 Country of residence other text CntryResdnceISOOTH The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Other, specify Alphanumeric

Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Exploratory 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

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

This element is recommended for pediatric stroke studies. Choose only one with which the parent most closely identifies. Ethnicity should be self-reported.

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
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 Other, specify Alphanumeric

Choose all that apply

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

Free-Form Entry

CSV