CDE Detailed Report

Disease: content
Sub-Domain: Demographics
CRF: welcome

Displaying 1 - 7 of 7
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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

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

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

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
C00035 Gender type GenderTyp Self-reported gender of the participant/subject. Self-reported gender of the participant/subject.. 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

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
CSV