CDE Detailed Report
Subdomain Name: Drugs
CRF: Study Drug Dosing
Displaying 1 - 6 of 6
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
