CDE Detailed Report

Disease: content
Subdomain Name: Demographics
CRF: welcome

Displaying 1 - 29 of 29
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
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 chromosomes of the participant/subject based upon genotyping Sex at birth XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex Alphanumeric Adult;Pediatric Supplemental 3.10 2018-07-26 00:00:00.0 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22692 Parent birth country name ParentBirthCntryName Name for country where the parent, guardian, or caregiver was born Name for country where the parent, guardian, or caregiver was born What is the parent, guardian, or caregiver's birth country name? Alphanumeric

Write in response.
It may be easier to record the full name of the country and code the data later using the ISO 3166-1 alpha-2 codes.

Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born

Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C00026 Language spoken Fluent text LangSpokeFluentTxt Text for each language that the participant/subject speaks fluently Text for each language that the participant/subject speaks fluently Please list each language the subject can speak fluently: Alphanumeric

Write in response.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

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 The free-text field related to 'Data source' specifying other text. Source of the data provided on the case report form Other, specify: Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C55578 Sexual orientation type SexualOrientTyp Self-reported sexual orientation of the participant/subject 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.

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00027 Language written Fluent text LangWrtnFlntlyTxt Text for each language that the participant/subject writes fluently 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 3.00 2013-07-20 10:21:25.65 Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

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 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 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 3.00 2013-07-20 10:21:25.65 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values 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 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 live 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 3.00 2013-07-11 15:03:49.2 Demographics Form Demographics Participant Characteristics 4000

Free-Form Entry

C00029 Language written fluent ISO code LangWrtnFlntlyTxtISOCode Code (ISO 639-2) for each language that the participant/subject writes fluently 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 3.00 2013-07-20 10:21:25.65 Demographics Form Demographics Participant Characteristics 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 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

Adult;Pediatric Supplemental 1.00 2016-06-03 11:18:55.0 Demographics Form 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 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) <br />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 3.1 10/16/2024 8:51:18 AM Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
C21806 Parent alive status ParentAliveStatus Specifies whether the participant's/subjects parents are still living 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

Adult;Pediatric Supplemental 1.00 2016-06-03 11:20:14.0 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00004 Birth country ISO code BirthCntryISOCode Code (ISO 3166-1 alpha-2 code) for country where the participant was born Code (ISO 3166-1 alpha-2 code) for country where the participant 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.

Adult;Pediatric Supplemental 3.1 10/16/2024 8:51:21 AM Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C00031 Race expanded category RaceCat Category of race(s) or region(s) the participant/subject most closely identifies with Category of race(s) or region(s) the participant/subject most closely identifies with What is the subject's racial background (expanded categories)? Not reported;Other;Unknown;Black African American;Black African;Black Afro Caribbean;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 Caribbean (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) 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) <br />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 3.00 2013-07-22 16:57:17.79 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 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 geneticall 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.

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
C00005 Birth country name BirthCntryName Name for country where the participant was born Name for country where the participant was born What is the subject's birth country name? Alphanumeric

Write in response.

Adult;Pediatric Supplemental 3.1 10/16/2024 8:51:20 AM Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C00035 Gender type GenderTyp Self-reported gender of the participant/subject Self-reported gender of the participant/subjec What is the subject's gender? Alphanumeric

Select one.

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 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 The participant's/subject's parent self declared racial origination, independent of ethnic origination, using OMB approved categorie 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.

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

2192199
C00007 Birth date BirthDate Date (and time, if applicable and known) the participant was born Date (and time, if applicable and known) the participant 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.).

Adult;Pediatric Supplemental 3.1 10/16/2024 8:51:14 AM Demographics Form Demographics Participant Characteristics

Free-Form Entry

793
C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form Who filled out this form? Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Friend;Physician;Chart/Medical record;Other, specify;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Friend;Physician;Chart/Medical record;Other, specify;Spouse Alphanumeric

Select one. If other is selected, please write in response.

Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C22689 Parent race expanded category ParentRaceCat Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with Category of race(s) or region(s) the particpant's/subject's parent/guardian most closely identifies with What is the parent, guardian, or caregiver's race, using expanded race categories? Not reported;Other;Unknown;Black African American;Black African;Black Afro Caribbean;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 Caribbean (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) Alphanumeric

Select all that apply.
Category of race(s) or region(s) the parent, guardian, or caregiver most closely identifies with

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 subject's enrolled on an annual basis using the racial categories listed.

Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Demographics Form Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C00020 Ethnicity USA category EthnUSACat Category of ethnicity the participant most closely identifies with Category of ethnicity the participant 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)<br />Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Adult;Pediatric Supplemental 3.1 10/16/2024 8:51:17 AM Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
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 live 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 3.00 2013-07-11 15:03:49.2 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

C22690 Parent Ethnicity USA category ParentEthnUSACat Category of ethnicity the parent, guardian, or caregiver most closely identifies with Category of ethnicity the parent, guardian, or caregiver most closely identifies with What is the parent, guardian, or caregiver's 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

Select one. If other is selected, please write in response.
Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be "collapsible" up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list.

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 3.00 2013-08-28 16:08:00.453 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel 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.

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

2180147
C14123 Country of residence name CntryResdnceName Country where the participant/subject currently lives Country where the participant/subject currently live What is the subject's current country of residence name? Alphanumeric

Write in response.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Demographics Form Demographics Participant Characteristics 255

Free-Form Entry

C22691 Parent birth country ISO code ParentBirthCntryISOCode Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was born Code (ISO 3166-1 alpha-2 code) for country where the participant's/subject's parent, guardian, or caregiver was bor What is the parent, guardian or caregiver's birht country 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.
It may be easier to record the full name of the country and code the data later using the ISO 3166-1 alpha-2 codes.

Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born

Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

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 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 3.00 2013-07-20 10:21:25.65 Demographics Form Demographics Participant Characteristics

Single Pre-Defined Value Selected

CSV