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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: Epilepsy
Sub-Domain: Demographics
CRF: Demographics
Item count: 7 (7 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
Male;Female;Unknown;Unspecified;
Male;Female;Unknown;Undifferentiated/Indeterminant/Intersex;
Alphanumeric
Choose one. Response is obtained by report of the participant/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 - http://grants.nih.gov/grants/funding/women_min/women_min.htm 04
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
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.) and in the format acceptable to the study database. 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.
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
Choose only one that 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 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” or “Negro” 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 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. (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
 
C00025
Language primary text
LangPrimryTxt
Text for the language the participant/subject speaks most often
Primary Language
eng;spa;sgn;chi;fre;ger;Other, specify;
English;Spanish;Sign Languages;Chinese languages;French;German;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
3.0
7/20/2013
Aliases for variable name not defined
Demographics
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
Demographics
Participant Characteristics
 
4000
Free-Form Entry
       
C00024
Language primary ISO code
LangPrimryCode
Code (ISO 639-2) for the language the participant/subject speaks most often
ISO 639-2 code
  
Alphanumeric
Choose one. 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 primary ISO 639-2 code
255
Free-Form Entry
       
11-23-2017
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