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title	CDASH EM Metadata Specifications

Metadataspec

Order

CDASH Variable Name

Question Text	Prompt	CRF Completion Instructions	CDASH Variable Name	SDTMIG Target Variable	SDTM Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value
1

EMYN

Any Tobacco Product Events	Any Tobacco Product Events	Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.	EMYN	EMYN	N/A	(NY)	Yes;No
2

SPTOBID

Tobacco Product Identifier	Tobacco Product Identifier	Indicate the product that was associated with the event.	SPTOBID	SPTOBID				VAPE-Z01
3

EMTERM

	What was the event or malfunction associated with this device?	Tobacco Product Device Event	Record a description of the toboacco product device event or malfunction that occurred.	EMTERM	EMTERM
4

EMSTDAT

	What was the start date when the event or malfunction first occurred or was identified?	Start Date	Record the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY).	EMSTDAT	EMSTDTC
5

EMPATT

What was the pattern of the event of malfunction?

Pattern of Tobacco Product Device Event

Record the pattern of the the event or malfunction that occurred.

EMPATT

Single Event; Intermittent; Continuous

EMACNDEV


	What action was taken with the device?	Action Taken With Device	Record what action was taken with the device as a result of the event.	EMACNDEV	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 ID	Record the ID of the primary AE associated with event, if any.	EMAENO(n)	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

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