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title	CDASH EM Metadata Specifications

Metadataspec

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	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.	Text	EMYN	EMYN	N/A	(NY)	No;Yes;No
2	Tobacco Product Identifier	Tobacco Product Identifier	Indicate the product that was associated with the event.	Text	SPTOBID	SPTOBID				VAPE-Z01

Section 2

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Controlled Terminology CodeList Name	Permissible Values
3	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.	Text	EMTERM	EMTERM
4	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).	Date	EMSTDAT	EMSTDTC
5	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.	Text	EMPATT	EMPATT			Single Event; Intermittent; Continuous
6	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.	Text	EMACNDEV	EMACNDEV		(DEACNDEV)	No Action Taken; Device Replaced; Battery Replaced
7	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.	Text	EMAENO(n)	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

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