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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 Dosing
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
C02017
Study drug start date and time
StdyDrugStrtDateTime
Date (and time, if applicable and known) on which the study drug usage begins
Start Date Start Time
  
Date or Date & Time
Record the date (and time) the participant/subject was prescribed to start taking study drug. 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. The Start Time column should be removed from the template form for those studies that do not need to collect time.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_START_DT
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug start date and time
 
Free-Form Entry
     
3162642
 
C02009
Study drug end date and time
StdyDrugEndDateTime
Date (and time, if applicable and known) the administration of the study drug ended
End Date End Time
  
Date or Date & Time
Record the date (and time) the participant/subject was prescribed to stop taking study drug. 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. The End Time column should be removed from the template form for those studies that do not need to collect time.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_END_DT
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug end date and time
 
Free-Form Entry
     
3162644
 
C02007
Study drug dose
StdyDrugDose
Dose of study drug taken per administration
Dose
  
Numeric Values
Record the dose of study drug the participant/subject was prescribed to take.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_DOSE
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug dose
 
Free-Form Entry
     
3162655
 
C02023
Study drug dose unit of measure
StdyDrugDoseUoM
Unit of measure of the study drug dosage administered
Dose Units
  
Alphanumeric
Record the unit for dose of study drug the participant/subject was prescribed to take. See the data dictionary for information on coding the dose unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_DOSE_UNIT
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug dose unit of measure
255
Free-Form Entry
     
3162656
 
C02026
Study drug dose unit of measure UCUM code
StdyDrugDoseUoMUCUMCd
Code that represents the dosage unit of measure of the study drug administered
Dose Units
  
Alphanumeric
Code the unit for measure for the dosage of study drug using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
7/18/2013
Aliases for variable name not defined
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug dose unit of measure UCUM code
255
Free-Form Entry
       
C02012
Study drug dose frequency
StdyDrugDoseFreq
Frequency of use of study drug
Dose Frequency
  
Alphanumeric
Record the frequency participant/subject was prescribed to take the dose of study drug. See the data dictionary for information on coding frequency using CDISC SDTM terminology.
CDISC SDTM Frequency Terminology, Code C71113 (http://evs.nci.nih.gov/ftp1/CDISC/SDTM/)
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_DRG_DOSE_FREQ
Study Drug Dosing
Drugs
Treatment/Intervention Data
Study drug dose frequency
255
Free-Form Entry
     
3162702
 
12-17-2018
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