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CDE ID | CDE Name | Variable Name | Definition / Description | Question Text | Permissible Value | Description | Data Type | Instructions | References | Population | Classification (e.g., Core) | Version # | Version Date | Aliases for Variable Name | CRF Module / Guideline | © or TM | Sub-Domain | Domain | Previous Title | Size | Input Restrictions | Min Value | Max Value | Measurement Type | LOINC ID | SNOMED | caDSR ID | CDISC ID |
C08147 | Data source | DataSource | Source of the data provided on the case report form | Who filled out this form? | Brother;Chart/Medical record;Daughter;Father;Friend;Mother;Participant/subject;Physician;Sister;Son;Spouse;Other, specify; | Brother;Chart/Medical record;Daughter;Father;Friend;Mother;Participant/subject;Physician;Sister;Son;Spouse;Other, specify; | Alphanumeric | Select one. If other is selected, please write in response. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Data source | | Multiple Pre-Defined Values Selected | | | | | | | |
C18667 | Data source other text | DataSourcOTH | The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form | Other, specify: | | | Alphanumeric | No instructions available | No references available | Adult;Pediatric | Supplemental | 1.0 | 5/27/2014 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | 4000 | Free-Form Entry | | | | | | | |
C00007 | Birth date | BirthDate | Date (and time, if applicable and known) the participant/subject was born | What is the subject's date of birth? | | | Date or Date & Time | Write in response.
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 | Supplemental | 3.0 | 7/25/2013 | caBIG: PER_BIR_DT; SCI CDEs: BIRTHDT | Demographics Form | | Demographics | Participant Characteristics | Birth date | | Free-Form Entry | | | | | | 793 | |
C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined genetically. | What is the subject's gender? | Female;Male;Unknown;Unspecified;Not reported; | Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported; | Alphanumeric | Select one. | No references available | Adult;Pediatric | Supplemental | 3.0 | 8/28/2013 | caBIG: PRSN_GENDER_TXT_TP; SCI CDEs: GENDER | Demographics Form | | Demographics | Participant Characteristics | Gender type | | Single Pre-Defined Value Selected | | | | | | 2200604 | |
C17396 | Sex genotype type | SexGenotypTyp | The difference between male and female, based upon the interactions between genes and between the genotype and the environment. Genotype is identified based on the individual's reproductive organs and functions assigned by chromosomal complement. | Sex at birth | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified; | XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex; | Alphanumeric | No instructions available | No references available | Adult;Pediatric | Supplemental | 3.1 | 7/26/2018 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Sex participant or subject type | | Single Pre-Defined Value Selected | | | | | | | |
C55578 | Sexual orientation type | SexualOrientTyp | Self-reported sexual orientation of the participant/subject | Sexual orientation | Bisexual;Gay/Lesbian;Heterosexual;Not reported;Other;Unknown; | Bisexual;Gay/Lesbian;Heterosexual;Not reported;Other;Unknown; | Alphanumeric | Select one. | No references available | Adult;Pediatric | Supplemental | 3.0 | 8/28/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | | Multiple Pre-Defined Values Selected | | | | | | | |
C00023 | Hand preference type | HandPrefTyp | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. | What is the subject's handedness preference, or dominant hand? | Left hand;Right hand;Both hands;Unknown; | Left hand;Right hand;Both hands;Unknown; | Alphanumeric | Select one. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/25/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Hand preference type | | Single Pre-Defined Value Selected | | | | | | 2180147 | |
C00030 | Race USA category | RaceUSACat | The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories. | What is the suject's racial background (as defined by OMB)? | 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 | Select all that apply.
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)
Jorde LB and Wooding SP. Genetic variation, classification and “race”. Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. NCI CDE Browser Public ID = 2192199 | Adult;Pediatric | Supplemental | 3.0 | 7/25/2013 | RACE_CAT_TXT | Demographics Form | | Demographics | Participant Characteristics | Race USA category | | Multiple Pre-Defined Values Selected | | | | | | 2192199 | |
C00031 | Race expanded category | RaceCat | Category of race(s) or region(s) the participant/subject most closely identifies with | What is the subject's racial background (expanded categories)? | Black African American;Black African;Black Afro Carribean;South/Central American Indian;North American Indian;Alaskan Native;Inuit;South Asian;Far Eastern Asian;Western Asian;White North American;White South American;White European;White Middle Eastern;White African;White Australian;Hawaiian;Pacific Islander;Not reported;Other;Unknown; | Black African American (for OMB purposes, this value is considered to be part of Black or African-American);Black African (for OMB purposes, this value is considered to be part of Black or African-American);Black Afro Carribean (for OMB purposes, this value is considered to be part of Black or African-American);South/Central American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);North American Indian (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Alaskan Native (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);Inuit (for OMB purposes, this value is considered to be part of American Indian or Alaska Native);South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);Far Eastern Asian (e.g., China, Japan, Korea, etc.) (for OMB purposes, this value is considered to be part of Asian);Western Asian (e.g., Pakistan, Iraq, Iran) (for OMB purposes, this value is considered to be part of Asian);White North American (for OMB purposes, this value is considered to be part of White);White South American (for OMB purposes, this value is considered to be part of White);White European (for OMB purposes, this value is considered to be part of White);White Middle Eastern (for OMB purposes, this value is considered to be part of White);White African (for OMB purposes, this value is considered to be part of White);White Australian (for OMB purposes, this value is considered to be part of White);Hawaiian (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);Not reported;Other;Unknown; | Alphanumeric | Select all that apply.
Choose all those with which the participant/ subject identifies. Race should be reported by the 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 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)
Jorde LB and Wooding SP. Genetic variation, classification and “race”. Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. NCI CDE Browser Public ID = 2192199 | Adult;Pediatric | Supplemental | 3.0 | 7/22/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Race expanded category | | Multiple Pre-Defined Values Selected | | | | | | | |
C00020 | Ethnicity USA category | EthnUSACat | Category of ethnicity the participant/subject most closely identifies with | What is the subject's ethnic background? | 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 | Select one. If other is selected, please write in response. | 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 | Supplemental | 3.0 | 8/28/2013 | ETHN_GRP_CAT_TXT | Demographics Form | | Demographics | Participant Characteristics | Ethnicity USA category | | Single Pre-Defined Value Selected | | | | | | 2192217 | |
C00004 | Birth country ISO code | BirthCntryISOCode | Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born | What is the subject's birth country (use ISO code)? | AU;CA;MX;GB;US; | AUSTRALIA;CANADA;MEXICO;UNITED KINGDOM;UNITED STATES; | Alphanumeric | Select one: If other is selected, please write in response. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/24/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Birth country ISO 3166-1 alpha-2 code | | Single Pre-Defined Value Selected | | | | | | | |
C00005 | Birth country name | BirthCntryName | Name for country where the participant/subject was born | What is the subject's birth country name? | | | Alphanumeric | Write in response. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/24/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Birth country name | 255 | Free-Form Entry | | | | | | | |
C10676 | Country of residence code | CntryResdnceISOCode | Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. | What is the subject's country of residence? | US;CA;GB;MX;AU;Other, specify; | USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify; | Alphanumeric | Select one: If other is selected, please write in response.
Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes. ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | Adult;Pediatric | Supplemental | 3.0 | 7/11/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Country of residence ISO 3166-1 alpha-2 code | | Single Pre-Defined Value Selected | | | | | | | |
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. | Other, specify: | | | Alphanumeric | Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes. ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) | Adult;Pediatric | Supplemental | 3.0 | 7/11/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | 4000 | Free-Form Entry | | | | | | | |
C14123 | Country of residence name | CntryResdnceName | Country where the participant/subject currently lives. | What is the subject's current country of residence name? | | | Alphanumeric | Write in response. | No references available | Adult;Pediatric | Supplemental | 3.0 | 6/21/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Country of residence name | 255 | Free-Form Entry | | | | | | | |
C00025 | Language primary text | LangPrimryTxt | Text for the language the participant/subject speaks most often | What is the subject's primary language (use ISO code)? | eng;spa;sgn;chi;fre;ger;Other, specify; | English;Spanish;Sign Languages;Chinese languages;French;German;Other, specify; | Alphanumeric | Write in response.
Select one. If other is selected, please write in response. | ISO 639-2 language codes (http://www.loc.gov/standards/iso639-2/php/code_list.php) | Adult;Pediatric | Supplemental | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Language primary text | | Single Pre-Defined Value Selected | | | | | | | |
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 | 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 | 1.0 | 5/27/2014 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | 4000 | Free-Form Entry | | | | | | | |
C00028 | Language spoken fluent ISO code | LangSpokeFluentISOCode | Code (ISO 639-2)for each language that the participant/subject speaks fluently | What are the ISO codes for each language the subject can speak fluently? The ISO codes represent the international codes for each country. | English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic;Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi); | English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic (ara);Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi); | Alphanumeric | Write in response.
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 | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Language spoken fluently ISO 639-2 code | | Multiple Pre-Defined Values Selected | | | | | | | |
C00026 | Language spoken Fluent text | LangSpokeFluentTxt | Text for each language that the participant/subject speaks fluently | Please list each language the subject can speak fluently: | | | Alphanumeric | Write in response. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Language spoken fluently text | 255 | Free-Form Entry | | | | | | | |
C00029 | Language written fluent ISO code | LangWrtnFlntlyTxtISOCode | Code (ISO 639-2) for each language that the participant/subject writes fluently | What are the ISO codes for each language the subject can write fluently? | | | Alphanumeric | Write in response.
Text for all languages participant/subject writes fluently. 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 | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Language written fluently ISO 639-2 code | 255 | Free-Form Entry | | | | | | | |
C00027 | Language written Fluent text | LangWrtnFlntlyTxt | Text for each language that the participant/subject writes fluently | Please list each language the subject can write fluently: | | | Alphanumeric | Write in response.
Text for all languages participant/subject writes fluently. 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 | 3.0 | 7/20/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | Language written fluently text | 255 | Free-Form Entry | | | | | | | |
C21805 | Caregiver primary extended type | CaregvPrimryExtendType | Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject | What is the relationahip between the person who acts as the primary caregiver for the subject and the subject? | Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify; | Adoptive father;Adoptive mother;Adoptive parents;Biological father;Biological father - not a primary caregiver;Biological mother;Biological mother - not a primary caregiver;Biological parents;Child;Grandfather;Grandmother;Home aide;Legal guardian;Long-term care/nursing facility staff;Parent;Relative;Self;Sibling;Spouse or partner;Stepfather;Stepmother;Stepparent;Unknown;Other, specify; | Alphanumeric | Select all that apply. If other is selected, please write in response.
Type of relationship between the person who acts as the primary caregiver for the participant/subject and the participant/subject | No references available | Adult;Pediatric | Supplemental | 1.0 | 6/3/2016 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | | Multiple Pre-Defined Values Selected | | | | | | | |
C21806 | Parent alive status | ParentAliveStatus | Specifies whether the participant's/subjects parents are still living | What are the living statuses of the subject's parents? | Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown; | Mother alive;Father alive;Father deceased;Mother deceased;Mother unknown;Father unknown; | Alphanumeric | Select all that apply.
Specifies whether the participant's/subjects parents are still living
Answer for both parents | No references available | Adult;Pediatric | Supplemental | 1.0 | 6/3/2016 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | | Multiple Pre-Defined Values Selected | | | | | | | |
C22684 | Parent gender type | ParentGenderTyp | Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of a parent determined genetically. | What is the parent, guardian or caregiver's gender? | Female;Male;Unknown;Unspecified;Not reported; | Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported; | Alphanumeric | Select one.
Self-reported gender of the participant's/subject's parent. Gender is the socially constructed identity of sex.
Choose one. Response is obtained by report of the participant/subject or parent, guardian, or caretaker. | No references available | Adult;Pediatric | Supplemental | 3.0 | 8/28/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | | Single Pre-Defined Value Selected | | | | | | 2200604 | |
C22688 | Parent Race USA Category | ParentRaceUSACat | The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories. | What is the parent, guardian, or caregiver's race, based on the OBM race standards? | 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 | Select all that apply.
The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categories.
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. | No references available | Adult;Pediatric | Supplemental | 3.0 | 7/25/2013 | Aliases for variable name not defined | Demographics Form | | Demographics | Participant Characteristics | | | Multiple Pre-Defined Values Selected | | | | | | 2192199 | |