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Common Data Element: Study drug dosage form text

Listed below are the details for the data element.

FITBIR
1.5
Element Type
Common Data Element
Study drug dosage form text
StdyDrugDosageFormTxt
Short Description
Text of dosage form used to administer study drug
Definition
Text of dosage form used to administer study drug
 
Notes
FITBIR|PDBP;
Creation Date
2014-04-01
Historical Notes
Study drug dosage form type
References
GENERAL: 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

Data Type
Alphanumeric
Input Restrictions
Free-Form Entry
Maximum Character Quantity
255
External Schema Permissible Value Mapping
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: 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.
Preferred Question Text
Dose Form
Category Groups and Classifications
DiseaseDomainSub-Domain
General (For all diseases) Treatment/Intervention Data Drugs

Classification

General (For all diseases):
Supplemental
Keywords
Labels
NINDS_CDE