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titleCDASH CM Metadata Specifications
Metadataspec
OrderCDASH Variable Name Question TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What is the category of the  medication the subject used to attempt to reduce nicotine dependencyMedication CategoryRecord the type of medicaiton the subject used to reduce nicotine dependency.IEYNWere all eligibility criteria met?Met CriteriaRecord Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolledIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.CMCAT

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;  



2IECATWhat is was the subcategory for category of the medicationcriterion?Medication SubcategoryCriterion TypeRecord the medication subcategory, if not pre-printed on the CRFwhether the criterion exception was Inclusion or Exclusion.CMSCAT


LAST ATTEMPTED USE WITH THIS MEDICATION
3IETESTCDWhat was the name identifier of the medication the subject used to reduce nicotine dependency
 MedicationRecord only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name.Applicant-Defined CRF Completion InstructionsCMTRT4What was the duration of the medication used to reduce nicotine dependency for the last attempt?  Collected DurationProvide the duration of the medication used. Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.CMDURinclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion IdentifierIf the subject was not eligible, record the identifying code for each criterion that was an exception.CMTRT5What was the duration unit of the medication used to reduce nicotine dependency for the last attempt Collected Duration UnitSelect the appropriate duration unit of the medication used. Record the start date of the medical event or condition using this format (DD-MON-YYYY).CMDURDAYS; MONTHS; YEARS