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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease:
Sub-Domain: Demographics
CRF: Demographics
Item count: 42 (14 distinct CDEs)
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
C18751
Sex participant or subject genotype other text
SexSubjectGenotypOTH
The free-text field related to 'Sex participant or subject genotype type' specifying other text. 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.
Other, specify
  
Alphanumeric
Choose only one
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
 
4000
Free-Form Entry
       
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.
Genotypic sex
XX;XY;XXX;XYY;XXY;Other, specify;
XX;XY;XXX;XYY;XXY;Other, specify;
Alphanumeric
Choose only one
No references available
Adult;Pediatric
Supplemental
3.1
7/26/2018
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Sex participant or subject type
 
Single Pre-Defined Value Selected
       
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.
Phenotypic sex
Female;Male;Unknown;Unspecified;Not reported;
Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported;
Alphanumeric
Choose only one. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 requires that gender be collected by self-report. Therefore if phenotypic sex is different than the self-reported gender, then that should be recorded and the self-reported gender should be the one reported to NIH.
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
3.0
8/28/2013
caBIG: PRSN_GENDER_TXT_TP; SCI CDEs: GENDER
Demographics
Demographics
Participant Characteristics
Gender type
 
Single Pre-Defined Value Selected
     
2200604
 
C00007
Birth date
BirthDate
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
3.0
7/25/2013
caBIG: PER_BIR_DT; SCI CDEs: BIRTHDT
Demographics
Demographics
Participant Characteristics
Birth date
 
Free-Form Entry
     
793
 
C00020
Ethnicity USA category
EthnUSACat
Category of ethnicity the participant/subject most closely identifies with
Ethnicity
  
Alphanumeric
“X” ONLY one with which you MOST CLOSELY identify
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
3.0
8/28/2013
ETHN_GRP_CAT_TXT
Demographics
Demographics
Participant Characteristics
Ethnicity USA category
 
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.
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
“X” those with which you identify
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.
Adult;Pediatric
Core
3.0
7/25/2013
RACE_CAT_TXT
Demographics
Demographics
Participant Characteristics
Race USA category
 
Multiple Pre-Defined Values Selected
     
2192199
 
C00022
Ethnicity USA maternal category
EthnUSAMatrnlCat
Ethnicity the participant/subject's mother most closely identifies with
Maternal 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.;Unknown;Not reported;
Alphanumeric
Chose ONLY one with which the participant/subject’s mother 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)
Pediatric
Supplemental
3.0
7/25/2013
MATERNAL_ETHN_GRP_CAT
Demographics
Demographics
Participant Characteristics
Ethnicity USA maternal category
 
Single Pre-Defined Value Selected
     
2192217;3182162
 
C00033
Race USA maternal category
RaceUSAMatrnlCat
Race(s) the participant/subject's mother most closely identifies with
Maternal 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’s mother 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)
Pediatric
Supplemental
3.0
7/25/2013
MATERNAL_RACE_CAT
Demographics
Demographics
Participant Characteristics
Race USA maternal category
 
Multiple Pre-Defined Values Selected
     
3182197;2192199
 
C10675
Country of origin maternal name
CntryofOriginMaternalName
Mother's country or countries of origin
Maternal country(s) of origin
  
Alphanumeric
This is a pediatric-specific element. Choose one. 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.
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists)
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Country of origin maternal name
255
Free-Form Entry
       
C11139
Country of origin maternal ISO code
CntryOfOriginMaternalISOCode
The ISO 3166-1 alpha-2 code for the participant's mother's country of origin.
   
Alphanumeric
This is a pediatric-specific element. Choose one. 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.
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists)
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Country of origin maternal ISO 3166-1 alpha-2 code
255
Free-Form Entry
       
C00021
Ethnicity USA paternal category
EthnUSAPatrnlCat
Ethnicity the participant/subject's father most closely identifies with
Paternal 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.;Unknown;Not reported;
Alphanumeric
Choose ONLY one with which the participant/subject’s father 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)
Pediatric
Supplemental
3.0
7/25/2013
PATERNAL_ETHN_GRP_CAT
Demographics
Demographics
Participant Characteristics
Ethnicity USA paternal category
 
Single Pre-Defined Value Selected
     
2182266;3182162;2192217
 
C00032
Race USA paternal category
RaceUSAPatrnlCat
Race(s) the participant/subject's father most closely identifies with
Paternal 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’s father 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)
Pediatric
Supplemental
3.0
7/25/2013
PATERNAL_RACE_CAT
Demographics
Demographics
Participant Characteristics
Race USA paternal category
 
Multiple Pre-Defined Values Selected
     
3182269;2192199, 3182197
 
C11136
Country of origin paternal name
CntryOfOriginPaternalName
Father's country or countries of origin
Paternal country(s) of origin
  
Alphanumeric
This is a pediatric-specific element. Choose one. 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.
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists)
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Country of origin paternal name
255
Free-Form Entry
       
C11138
Country of origin paternal ISO code
CntryOfOriginPaternalISOCode
The ISO 3166-1 alpha-2 code for the participant's father's country of origin.
   
Alphanumeric
This is a pediatric-specific element. Choose one. 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.
ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists)
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Country of origin paternal ISO 3166-1 alpha-2 code
255
Free-Form Entry
       
12-17-2018
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