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Order	CDASHIG Variable	Question Text	Prompt	Data Type	CRF Completion Instructions	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Codelist Name	Permissible Values	Pre-populated Value	List Style
1	SPTOBID	What was the tobacco product identifier?	Tobacco Product Identifier	text	Indicate the tobacco product that was involved in the incident.	SPTOBID				VAPE-Z01	radio
6	TETERM	Describe What was the device event.event associated with this tobacco product?	Tobacco Product Device Event	text	Record a description of the device event that occurred.	TETERM
7	TESTDAT	What was the start date when the event first occurred or was identified?	Start Date	text	Record the date that the device event first occurred or was noted using this using this format (DD-MON-YYYY).	TESTDTC
10	TEPATT	How frequently did the event occur?	Event Frequency	text	Record how often the incident event occurred.	TEPATT			Single Event; Intermittent; Continuous		radio
11	TEACNDEV	What action was taken with the study device?	Action Taken With Device	text	Record what action was taken with the device tobacco product as a result of the incidentevent.	TEACNDEV		(DEACNDEV)	No change; Device replacedChange; Tobacco Product Replaced;		radio
12	TEAENO(n)	What was the identifier for the primary adverse event(s) associated with or related to this device event?	Related Adverse Event ID	text	Record the ID of the primary AE associated with the device event, if any.	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

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