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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: Drugs
CRF: Study Drug Compliance
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
C02004
Study drug dispensed date and time
StdyDrugDispnsdDateTime
Date (and time, if applicable and known) on which a participant/subject was given or applied a therapeutic agent (drug, intervention therapy) used in a clinical trial protocol
Date Dispensed
  
Date or Date & Time
Record the date (and time) the study drug/biologic was dispensed to participant/subject. 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
7/18/2013
STDY_AGNT_DISPNS_DT
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug dispensed date and time
 
Free-Form Entry
     
3163963
 
C02018
Study drug dispensed count
StdyDrugDispnsdCt
Count of amount of study drug dispensed to the participant/subject
Amount Dispensed
  
Numeric Values
Record the amount of study drug/biologic that was dispensed to participant/subject.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_DISPNS_AMNT
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug dispensed count
 
Free-Form Entry
     
3164207
 
C02010
Study drug dosage form text
StdyDrugDosageFormTxt
Text of dosage form used to administer study drug
Dose Form
  
Alphanumeric
Record the dosage form for amount of study drug/biologic that was dispensed to participant/subject.The bottom of the form template includes examples of dose forms. Please refer to the US FDA CDER standard of drug dosage forms for additional examples.
FDA CDER Data Element Number = C-DRG-00201; Data Element NCI Concept ID: C42636 - http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071666.htm
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_FORM
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug dosage form type
255
Free-Form Entry
     
3164208
 
C02005
Study drug returned date and time
StdyDrugRetrnDateTime
Date (and time, if applicable and known) on which the study drug was returned
Date Returned
  
Date or Date & Time
Record the date (and time) the participant/subject returned the study drug/biologic. 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
7/18/2013
STDY_DRG_RETRN_DT
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug returned date and time
 
Free-Form Entry
     
3164209
 
C02021
Study drug expected taken count
StdyDrugExpctdTakenCt
Count of expected amount of study drug taken
Expected Amount Taken
  
Numeric Values
Record the amount of study drug/biologic the participant/subject was expected to take based on the prescribed dosing.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_TKN_EXP_DOS
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug expected taken count
 
Free-Form Entry
     
3165013
 
C02020
Study drug expected returned count
StdyDrugExpectReturnCt
Count of expected amount of study drug returned
Expected Amount Returned
  
Numeric Values
Record the amount of study drug/biologic the participant/subject was expected to return based on the prescribed dosing.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_RTN_EXP_DOS
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug expected returned count
 
Free-Form Entry
     
3165014
 
C02019
Study drug actual return count
StdyDrugActualReturnCt
Count of amount of study drug returned
Actual Amount Returned
  
Numeric Values
Record the actual amount (versus reported amount) of study drug/biologic returned by the participant/subject.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_RTRN_AMNT
Study Drug Compliance
Drugs
Treatment/Intervention Data
Study drug actual returned count
 
Free-Form Entry
     
3164210
 
12-09-2018
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