CDE Detailed Report | NINDS Common Data Elements

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Subdomain Name: Demographics
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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	External Id caDSR
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 birt	Sex assigned at birth	Male;Female;Intersex;Unknown;Other, specify	Male;Female;Intersex;Unknown;Other, specify	Alphanumeric			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 birt	Gender identity	Male;Female;Unknown;Other, specify	Male;Female;Unknown;Other, specify	Alphanumeric			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 tex	Other, specify			Alphanumeric			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 tex	Other, specify			Alphanumeric			Adult;Pediatric	Supplemental	1.00	2020-05-12 10:50:12.0	Demographics	Demographics	Participant Characteristics	4000	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.	ISO 8601 - https://www.iso.org/home.html <br />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
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. Response is obtained by report of the participant/subject 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	3.00	2013-08-28 16:08:00.453	Demographics	Demographics	Participant Characteristics		Single Pre-Defined Value Selected	2192217
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 that the participant's/subject's father 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. (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	3.00	2013-07-25 08:54:08.2	Demographics	Demographics	Participant Characteristics		Single Pre-Defined Value Selected	2182266;3182162;2192217
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 that the participant's/subject's mother 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. (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	3.00	2013-07-25 08:54:08.2	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 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 that apply. Response is obtained by report of the participant/subject 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	3.00	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	Choose all those racial categories that the participant's/subject'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	3.00	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	Choose all those racial categories that the participant's/subject'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	3.00	2013-07-25 08:54:08.2	Demographics	Demographics	Participant Characteristics		Multiple Pre-Defined Values Selected	3182197;2192199