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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: Huntington's Disease
Sub-Domain: Demographics
CRF: General Core
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
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.
ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm 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
Adult;Pediatric
Core
3.0
7/25/2013
caBIG: PER_BIR_DT; SCI CDEs: BIRTHDT
General Core
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.
Gender
Female;Male;Unknown;Unspecified;Not reported;
Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported;
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 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
General Core
Demographics
Participant Characteristics
Gender type
 
Single Pre-Defined Value Selected
     
2200604
 
C00020
Ethnicity USA category
EthnUSACat
Category of ethnicity the participant/subject most closely identifies with
Ethnicity
  
Alphanumeric
Choose one. 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
Core
3.0
8/28/2013
ETHN_GRP_CAT_TXT
General Core
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;White;Asian;Unknown;Black or African-American;Not reported;Native Hawaiian or Other Pacific Islander;
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 Europe, the Middle East, or North Africa.;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.;Could not be determined or unsure;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.”;Not reported;A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;
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
General Core
Demographics
Participant Characteristics
Race USA category
 
Multiple Pre-Defined Values Selected
     
2192199
 
C00015
Education year count
EduYrCt
Number of years of education completed (age 5 and beyond)
Number of years of education
  
Numeric Values
For years completed, after the age of 5, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count.
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/22/2013
Aliases for variable name not defined
General Core
Demographics
Participant Characteristics
Education level USA type
 
Free-Form Entry
0
30
year
  
3134878
 
C00313
Medical history condition SNOMED CT code
MedclHistCondSNOMEDCTCode
Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject
SNOMED CT Code
  
Alphanumeric
Code each of the medical history conditions using SNOMED CT
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
General Core
Demographics
Participant Characteristics
Medical history condition SNOMED CT code
255
Free-Form Entry
       
C00322
Medical history condition text
MedclHistCondTxt
Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history
Medical History Term
  
Alphanumeric
Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
General Core
Demographics
Participant Characteristics
Medical history condition text
4000
Free-Form Entry
     
2003874
 
03-22-2017
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