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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: General (For all diseases)
Sub-Domain: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Screening Log
Item count: 17 (17 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
C17399
Global unique identifier number
GlobalUniqueIdNum
Global Unique ID (GUID) which uniquely identifies a subject
Screening ID
  
Alphanumeric
No instructions available
Johnson, S.B., Whitney, G., McAuliffe, M., Wang, H., McCreedy, E., Rozenblit, L., and Evans, C.C. (2010). Using Global Unique identifiers to link autism collections. J. Am. Med. Inform. Assoc., in press. Published online July 17, 2010. 10.1136/jamia.2009.002063.
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
GUID
255
Free-Form Entry
       
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 -https://www.iso.org/home.html
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
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Birth date
 
Free-Form Entry
     
793
 
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
XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Unspecified;
XX;XY;XXX;XYY;XXY;Other, specify;Unknown;Undifferentiated/Indeterminant/Intersex;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.1
7/26/2018
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Sex participant or subject type
 
Single Pre-Defined Value Selected
       
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
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
 
4000
Free-Form Entry
       
C18492
Screening visit date and time
ScreenVisitDateTime
Date (and time, if applicable and known) the participant/subject was interviewed and screened for potential enrollment into the study
Screening Date
  
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 (and 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.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
  
Free-Form Entry
       
C18493
Screening visit eligibility status
ScreenVisitEligibilityStatus
The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study.
Eligibility
Eligible;Eligible but declined;Not eligible;Other, specify;
Eligible;Eligible but declined;Not eligible;Other, specify;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
  
Single Pre-Defined Value Selected
       
C19069
Screening visit eligibility other text
ScreenVisitEligibilityOTH
The free-text field related to 'Screening visit eligibility status' specifying other text. The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study.
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
 
4000
Free-Form Entry
       
C18494
Screening visit ineligibility primary reason
ScreenVisitIneligPrimryRsn
The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a study.
Primary Reason
Inclusion;Exclusion;Other, specify;
Inclusion;Exclusion;Other, specify;
Alphanumeric
If not eligible, choose one.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
  
Single Pre-Defined Value Selected
       
C19070
Screening visit ineligibility primary other text
ScreenVisitIneligPrimryOTH
The free-text field related to 'Screening visit ineligibility primary reason' specifying other text. The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a study.
Other, specify
  
Alphanumeric
If not eligible, choose one.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
 
4000
Free-Form Entry
       
C02217
Inclusion criterion not met number
InclusionCriterionNotMetNum
Inclusion criterion number(s) the participant/subject did not meet
Inclusion Number
  
Alphanumeric
Enter the number(s) for the inclusion criterion/criteria the participant/subject did not meet. Multiple numbers should be separated by a comma.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
P_INELIGIB_INCL
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Inclusion criterion not met number
255
Free-Form Entry
     
3151307
 
C02216
Exclusion criterion not met number
ExclusionCriterionNotMetNum
Exclusion criterion number(s) the participant/subject did not meet
Exclusion Number
  
Alphanumeric
Enter the number(s) for the exclusion criterion/criteria the participant/subject did not meet. Multiple numbers should be separated by a comma.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
P_INELIGIB_EXCL
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Exclusion criterion not met number
255
Free-Form Entry
     
3151311
 
C02209
Informed consent obtained indicator
InfConsntObtInd
Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study.
Consent obtained
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If YES, record date informed consent was obtained.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
INF_CF_SIG_IND2
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Informed consent obtained indicator
 
Single Pre-Defined Value Selected
     
2186028
 
C02210
Enrolled in study indicator
EnrldStdyInd
Indicator of whether the participant/subject was enrolled into the clinical research study.
Enrolled
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If YES, record the date enrolled.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
P_STDY_ENROLL_YN
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Enrolled in study indicator
 
Single Pre-Defined Value Selected
     
3152168
 
C18495
Protocol ID number
ProtIDNum
The designated number used to identify the protocol or study to which participants/subjects will be enrolled.
Study ID
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
 
255
Free-Form Entry
       
C18496
Screening visit not enrolled primary reason
ScreenVisitNotEnrldPrimryRsn
The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visit.
Primary Reason
Consent withdrawn;No longer eligible;Other, specify;
Consent withdrawn;No longer eligible;Other, specify;
Alphanumeric
If not enrolled, choose one.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
  
Single Pre-Defined Value Selected
       
C19071
Screening visit not enrolled primary other text
ScreenVisitNotEnrldPrimryOTH
The free-text field related to 'Screening visit not enrolled primary reason' specifying other text. The primary reason to indicate why the potential participant/subject is not enrolled in a study during a screening visit.
Other, specify
  
Alphanumeric
If not enrolled, choose one.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
 
4000
Free-Form Entry
       
C02211
Enrolled in study date and time
EnrldStdyDateTime
Date (and time, if applicable and known) the participant/subject is enrolled into the study
Date Enrolled
  
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 (and 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.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PARTIC_ENROL_DT
Screening Log
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Enrolled in study date and time
 
Free-Form Entry
     
2434998,2746541
 
12-09-2018
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