CDE Detailed Report

Disease: Friedreich's Ataxia
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 8 of 8
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
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 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 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
C00028 Language spoken fluent ISO code LangSpokeFluentISOCode Code (ISO 639-2)for each language that the participant/subject speaks fluently Code (ISO 639-2)for each language that the participant/subject speaks fluently Language English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic;Russian (rus);Italian (ita);Polish (pol);Other specify English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic (ara);Russian (rus);Italian (ita);Polish (pol);Other specify Alphanumeric

Choose all that apply.

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

Multiple Pre-Defined Values 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 those with which the participant/ subject 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. (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.

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
C10676 Country of residence code CntryResdnceISOCode Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Country of Residence US;CA;GB;MX;AU;Other, specify USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify Alphanumeric

Choose one.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Exploratory 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C10677 ZIP partial code ZIPPartialCode First three digits of the zip code where the participant/subject currently lives. First three digits of the zip code where the participant/subject currently lives. Zip Code Alphanumeric

This is an optional field, if this information is not provided enter 000.

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C18806 Country of residence other text CntryResdnceISOOTH The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Other, specify Alphanumeric

Choose one.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Exploratory 3.00 2013-07-11 15:03:49.2 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

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 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics

Free-Form Entry

793
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