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titleCDASH CM EM Metadata Specifications
Metadataspec
OrderCDASH Variable Name Question TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1EMYNAny Tobacco Product EventsAny Tobacco Product EventsIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.EMYNN/A(NY)Yes;No
2SPTOBIDTobacco Product Identifier Tobacco Product Identifier Indicate the  product that  was associated with the event. SPTOBID


VAPE-Z01
3EMTERM

What was the event or malfunction associated with this device?

Tobacco Product Device EventRecord a description of the toboacco product device event or malfunction that occurred.EMTERM



4EMSTDATWhat was the start date when the event or malfunction first occurred or was identified?Start DateRecord the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY).EMSTDTC



5EMPATTWhat was the pattern of the event of malfunction?Pattern of Tobacco Product Device EventRecord the pattern of the the event or malfunction that occurred.EMPATT

Single Event; Intermittent; Continuous

EMACNDEVWhat action was taken with the device?Action Taken With DeviceRecord what action was taken with the device as a result of the event.EMACNDEV
(DEACNDEV)

No Action Taken; Device Replaced; Battery Replaced



EMAENO(n)What was the identifier for the primary adverse event(s) associated with or related to this device event?Related Adverse Event IDRecord the ID of the primary AE associated with event, if any.N/AASSOCIATE WITH RELATED RECORD VIA RELREC