CDE Detailed Report

Disease: General (For all diseases)
Sub-Domain: Drugs
CRF: Study Drug Dosing

Displaying 1 - 6 of 6
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02007 Study drug dose StdyDrugDose Dose of study drug taken per administration 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data

Free-Form Entry

3162655
C02009 Study drug end date and time StdyDrugEndDateTime Date (and time, if applicable and known) the administration of the study drug ended 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data

Free-Form Entry

3162644
C02012 Study drug dose frequency StdyDrugDoseFreq Frequency of use of study drug 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data 255

Free-Form Entry

3162702
C02017 Study drug start date and time StdyDrugStrtDateTime Date (and time, if applicable and known) on which the study drug usage begins 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data

Free-Form Entry

3162642
C02023 Study drug dose unit of measure StdyDrugDoseUoM Unit of measure of the study drug dosage administered 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data 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 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 3.00 2013-07-18 16:35:19.49 Study Drug Dosing Drugs Treatment/Intervention Data 255

Free-Form Entry

CSV