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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: Informed Consent and Enrollment
Item count: 6 (6 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
C02209
Informed consent obtained indicator
InfConsntObtInd
Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study.
Was informed 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
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Informed consent obtained indicator
 
Single Pre-Defined Value Selected
     
2186028
 
C02212
Informed consent obtained date and time
InformConsntObtnDateTime
Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document.
Date of Consent
  
Date or Date & Time
Record the date(and time) the informed consent form is signed. 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.
No references available
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Informed consent obtained date and time
 
Free-Form Entry
     
2435038,656
 
C02210
Enrolled in study indicator
EnrldStdyInd
Indicator of whether the participant/subject was enrolled into the clinical research study.
Was the participant/subject enrolled into the study?
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
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Enrolled in study indicator
 
Single Pre-Defined Value Selected
     
3152168
 
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
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Enrolled in study date and time
 
Free-Form Entry
     
2434998,2746541
 
C02213
Randomized indicator
RandomizedInd
Indicator of whether the participant/subject was randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group.
Was the participant/subject randomized?
Yes;No;Not applicable;
Yes;No;Not applicable;
Alphanumeric
Choose one. If YES, record the date randomized. This CDE should only be on the CRF if the study is a randomized clinical trial. Otherwise, it can be removed.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PT_RNDM_IND
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Randomized indicator
 
Single Pre-Defined Value Selected
     
2183079
 
C02214
Randomized date and time
RandomizedDateTime
Date (and time, if applicable and known) the participant/subject is randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group.
Date randomized
  
Date or Date & Time
Record the date(and time) the participant/subject is randomized to a treatment or control group. 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. This CDE should only be included on the CRF if the study is a randomized clinical trial. Otherwise, it can be removed.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PT_RNDM_DT
Informed Consent and Enrollment
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Randomized date and time
 
Free-Form Entry
     
2182072,2186028
 
12-17-2018
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