CDE Detailed Report
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 8 of 8
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
Choose one. Response is obtained by report of the participant/subject or caretaker. Internally held sense of the participant/subject gender which may or may not correspond to the individual's genotypic or phenotypic sex. |
Adult | Core | 1.00 | 2020-01-07 14:20:24.0 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| 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 |
Enter the other sex assigned at birth reported by the participant/subject or caretaker. |
Adult | Supplemental | 1.00 | 2020-05-12 10:47:54.0 | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| 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 |
Enter the other gender identity reported by the participant/subject or caretaker. |
Adult | Supplemental | 1.00 | 2020-05-12 10:50:12.0 | Demographics | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| 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 of birth to the level of precision known (e.g., month/day/year, year, month/year, etc.). The preferred format for recording date is MM/DD/YYYY. 99/99/9999 can be used to indicate an unknown date. |
ISO 8601 - https://www.iso.org/home.html | Adult | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
793 | |||||||||
| C00012 | Education level USA type | EduLvlUSATyp | Highest grade or level of school participant/subject has completed or the highest degree received | Highest grade or level of school participant/subject has completed or the highest degree received | Education Level | 7th Grade or less;8th to 12th Grade;High school graduate;2-year college;4-year college;Postgraduate;Unknown | 7th Grade or less;8th to 12th Grade;High school graduate;2-year college;4-year college;Postgraduate;Unknown | Alphanumeric |
Select the highest level attained. Choose only one, the highest level of education the participant/subject has attained. |
National Health and Nutrition Examination Survey (NHANES); National Health Interview Survey (NHIS); PhenX Toolkit Current Educational Attainment #011001 (https://www.phenxtoolkit.org) | Adult | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
3134878 | |||||||
| 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 | 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 | 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 (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm)<br />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 | Core | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
| 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;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.;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 (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm)<br />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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | |||||||
| 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 |
Choose one. Response is obtained by report of the participant/subject or caretaker. The assemblage of physical properties or qualities by which male is distinguished from female. Male is a person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. Female is a person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. Intersex is a person (one of unisexual specimens) who is born with genitalia and/or secondary sexual characteristics of indeterminate sex, or which combine features of both sexes. |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm). | Adult | Core | 1.00 | 2020-01-07 14:00:16.0 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
