CDE Detailed Report

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

Displaying 1 - 7 of 7
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
C02021 Study drug expected taken count StdyDrugExpctdTakenCt Count of expected amount of study drug taken 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3165013
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 (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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3163963
C02005 Study drug returned date and time StdyDrugRetrnDateTime Date (and time, if applicable and known) on which the study drug was returned 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3164209
C02010 Study drug dosage form text StdyDrugDosageFormTxt Text of dosage form used to administer study drug 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data 255

Free-Form Entry

3164208
C02018 Study drug dispensed count StdyDrugDispnsdCt Count of amount of study drug dispensed to the participant/subject 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3164207
C02019 Study drug actual return count StdyDrugActualReturnCt Count of amount of study drug returned 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3164210
C02020 Study drug expected returned count StdyDrugExpectReturnCt Count of expected amount of study drug returned 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 3.00 2013-07-18 16:35:19.49 Study Drug Compliance Drugs Treatment/Intervention Data

Free-Form Entry

3165014
CSV