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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: Stroke
Sub-Domain: Demographics
CRF: Demographics
Item count: 15 (15 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
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.
Gender
  
Alphanumeric
This element should be collected along with the other elements of the Sophia Classification.
Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009 Oct;98(10):1556-67.
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.).
Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.
Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17:573-581.; Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):259-69.
Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382.
ISO 8601http://www.iso.org/iso/home.html
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
Choose only one with which the participant/ subject most closely identifies. Ethnicity 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 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
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)
Adult;Pediatric
Core
3.0
7/25/2013
RACE_CAT_TXT
Demographics
Demographics
Participant Characteristics
Race USA category
 
Multiple Pre-Defined Values Selected
     
2192199
 
C00026
Language spoken Fluent text
LangSpokeFluentTxt
Text for each language that the participant/subject speaks fluently
Other, specify
  
Alphanumeric
Choose all that apply
No references available
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Language spoken fluently text
255
Free-Form Entry
       
C00028
Language spoken fluent ISO code
LangSpokeFluentISOCode
Code (ISO 639-2)for each language that the participant/subject speaks fluently
Language(s) fully fluent
  
Alphanumeric
Choose all that apply. 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
Demographics
Participant Characteristics
Language spoken fluently ISO 639-2 code
 
Multiple Pre-Defined Values Selected
       
C14123
Country of residence name
CntryResdnceName
Country where the participant/subject currently lives.
Country of residence
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
6/21/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Country of residence 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.
Country
US;CA;GB;MX;AU;Other, specify;
USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);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)
Adult;Pediatric
Supplemental
3.0
7/11/2013
Aliases for variable name not defined
Demographics
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)
Adult;Pediatric
Supplemental
3.0
7/11/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
 
4000
Free-Form Entry
       
C10677
ZIP partial code
ZIPPartialCode
First three digits of the zip code where the participant/subject currently lives.
Zip/Postal Code
  
Alphanumeric
This is an optional field, if this information is not provided enter 000.
NINDS Genetics Repository, Required Clinical Data Elements for subjects with Cerebrovascular Disease - http://ccr.coriell.org/Sections/Collections/NINDS/Cerebrovascular.aspx?PgId=190&coll=ND
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Zip code
255
Free-Form Entry
       
C14124
Social security number
SocialSecurityNum
A nine-digit number issued to U.S. citizens, permanent residents, and temporary (working) residents under section 205(c)(2) of the Social Security Act, codified as 42 U.S.C. § 405(c)(2). The number is issued to an individual by the Social Security Administration, an independent agency of the United States government.
Social security number
  
Numeric Values
Providing this information is entirely voluntary and the participant/ subject may refuse. This information must be kept confidential according to the Privacy Act of 1974, and must only be used for research purposes.
The preferred format for recording SSN is _ _ _ - _ _ - _ _ _ _
Framingham Heart Study
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Demographics
Demographics
Participant Characteristics
Social security number
 
Free-Form Entry
       
C00022
Ethnicity USA maternal category
EthnUSAMatrnlCat
Ethnicity the participant/subject's mother most closely identifies with
Maternal race
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
This element is recommended for pediatric stroke studies.
Choose only one with which the parent most closely identifies. Ethnicity should be self-reported.
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
This element is recommended for pediatric stroke studies.
Choose all those with which the parent identifies. Race should be self-reported.
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)
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
 
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
This element is recommended for pediatric stroke studies.
Choose only one with which the parent most closely identifies. Ethnicity should be self-reported.
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
This element is recommended for pediatric stroke studies.
Choose all those with which the parent identifies. Race should be self-reported.
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)
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
 
07-20-2019
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