CDE Detailed Report
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 7 of 7
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject | Self-reported gender of the participant/subjec | Gender | Alphanumeric |
Choose one. Response is obtained by report of the participant/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 - http://grants.nih.gov/grants/funding/women_min/women_min.htm 04 | Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2200604 | |||||||||
| C18732 | Language primary other text | LangPrimryOTH | The free-text field related to 'Language primary text' specifying other text. Text for the language the participant/subject speaks most often | The free-text field related to 'Language primary text' specifying other text. Text for the language the participant/subject speaks most often | Other, specify | Alphanumeric |
Text for participant's/subject's primary language. 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 | 1.00 | 2014-05-27 13:34:46.0 | 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 |
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.) and in the format acceptable to the study database. 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. |
No references available | 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 only one that 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 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 | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
| C00024 | Language primary ISO code | LangPrimryCode | Code (ISO 639-2) for the language the participant/subject speaks most often | Code (ISO 639-2) for the language the participant/subject speaks most often | ISO 639-2 code | Alphanumeric |
Choose one. 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 | 255 |
Free-Form Entry |
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| C00025 | Language primary text | LangPrimryTxt | Text for the language the participant/subject speaks most often | Text for the language the participant/subject speaks most often | Primary Language | eng;spa;sgn;chi;fre;ger;Other, specify | English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify | Alphanumeric |
Text for participant's/subject's primary language. 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 |
Single Pre-Defined Value Selected |
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| 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 (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) | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 |
