CDE Detailed Report
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 14 of 14
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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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 with which the participant/subject's father 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) | 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 with which the participant/subject's mother 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) | Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:23 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182197;2192199 | |||||||
C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject | Self-reported gender of the participant/subjec | Phenotypic sex | Alphanumeric |
Choose only one. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 requires that gender be collected by self-report. Therefore if phenotypic sex is different than the self-reported gender, then that should be recorded and the self-reported gender should be the one reported to NIH. |
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 | |||||||||
C10675 | Country origin maternal name | CntryOriginMaternalName | Mother's country or countries of origin | Mother's country or countries of origin | Maternal country(s) of origin | Alphanumeric |
This is a pediatric-specific element. 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 | 3.10 | 2023-03-15 16:59:46.0 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C11136 | Country origin paternal name | CntryOriginPaternalName | Father's country or countries of origin | Father's country or countries of origin | Paternal country(s) of origin | Alphanumeric |
This is a pediatric-specific element. 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 | 3.10 | 2023-03-15 17:00:22.0 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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C11138 | Country of origin paternal ISO code | CntryOfOriginPaternalISOCode | The ISO 3166-1 alpha-2 code for the participant's father's country of origin | The ISO 3166-1 alpha-2 code for the participant's father's country of origi | Alphanumeric |
This is a pediatric-specific element. 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 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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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 (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 | 3.1 | 10/16/2024 8:51:14 AM | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
793 | |||||||||
C11139 | Country of origin maternal ISO code | CntryOfOriginMaternalISOCode | The ISO 3166-1 alpha-2 code for the participant's mother's country of origin | The ISO 3166-1 alpha-2 code for the participant's mother's country of origi | Alphanumeric |
This is a pediatric-specific element. 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 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics | 255 |
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 |
"X" ONLY one with which you MOST CLOSELY identify |
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 | 3.1 | 10/16/2024 8:51:17 AM | 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 | Genotypic sex | XX;XY;XXX;XYY;XXY;Other, specify | XX;XY;XXX;XYY;XXY;Other, specify | Alphanumeric |
Choose only one |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2018-07-26 00:00:00.0 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
||||||||
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 with which the participant/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. (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 | 3.1 | 10/16/2024 8:51:24 AM | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2182266;3182162;2192217 | |||||||
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 |
Choose only one |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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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 |
Chose ONLY one with which the participant/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. (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 | 3.1 | 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 |
"X" those with which you identify |
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) 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 | 3.1 | 10/16/2024 8:51:18 AM | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 |