CDE Detailed Report

Disease: Parkinson's Disease
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
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

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

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

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

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
CSV