CDE Detailed Report
Subdomain Name: Drugs
CRF: Study Drug Compliance
Displaying 1 - 7 of 7
| CDE ID | CDE Name | Variable Name | Definition | Short Description | 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 / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||
| 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 |
