CDE Detailed Report
Subdomain Name: Demographics
CRF: General Core
Displaying 1 - 10 of 10
| 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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| C58780 | Birth sex assigned type other text | BirthSexAssignTypOTH | The free-text field related to 'Birth sex assigned type', specifying other text. Self-reported phenotypic sex of participant, assigned at birth | The free-text field related to 'Birth sex assigned type', specifying other text. Self-reported phenotypic sex of participant, assigned at birth | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:51:15 AM | General Core | 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. Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | The free-text field related to 'Gender identity type', specifying other text. Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:51:17 AM | General Core | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
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| C58676 | Birth sex assigned type | BirthSexAssignTyp | Self-reported phenotypic sex of participant, assigned at birth | Self-reported phenotypic sex of participant, assigned at birth | Sex assigned at birth | Male;Female;Intersex;Unknown;Other, specify | Male;Female;Intersex;Unknown;Other, specify | Alphanumeric | Adult;Pediatric | Core | 1.1 | 10/16/2024 8:51:15 AM | General Core | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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| C58677 | Gender identity type | GenderIdTyp | Gender identity self-identified by the participant. Gender type may or may not match sex assigned at birth | Gender identity self-identified by the 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 | Adult;Pediatric | Core | 1.1 | 10/16/2024 8:51:16 AM | General Core | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
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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 |
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 | 3.1 | 10/16/2024 8:51:17 AM | General Core | 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 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 reported | 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 | 3.1 | 10/16/2024 8:51:18 AM | General Core | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | |||||||
| C00313 | Medical history condition SNOMED CT code | MedclHistCondSNOMEDCTCode | Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject | Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject | SNOMED CT Code | Alphanumeric |
Code each of the medical history conditions using SNOMED CT |
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | General Core | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C00322 | Medical history condition text | MedclHistCondTxt | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Medical History Term | Alphanumeric |
Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT |
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | General Core | Demographics | Participant Characteristics | 4000 |
Free-Form Entry |
2003874 | ||||||||
| 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.). 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 - 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 | 3.1 | 10/16/2024 8:51:14 AM | General Core | Demographics | Participant Characteristics |
Free-Form Entry |
793 | |||||||||
| C00015 | Education year count | EduYrCt | Number of years of education completed (age 5 and beyond) | Number of years of education completed (age 5 and beyond) | Number of years of education | Numeric Values |
For years completed, after the age of 5, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count. |
No references available | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-07-22 16:57:17.79 | General Core | Demographics | Participant Characteristics |
Free-Form Entry |
0 | 30 | year | 3134878 |
