Tobacco Product Events and Malfunctions (EM)

In tobacco studies, subjects may report problems or malfunctions with the device used to deliver the tobacco product, which may or may not result in adverse events. These may be called "events" or "malfunctions." Often the true cause of the issue cannot be determined until a cause analysis is performed. Theses device related issues or events may or may not be a concern for a given trial depending upon whether the device has already been approved by regulators. 

The Tobacco Product Events and Malfunctions (EM)) domain is based on the Events General Observation class and is used to represent device issues and/or events. 

There is more than one approach to identifying tobacco product devices involved with these events/incidents. The method chosen will depend upon the granularity at which the sponsor needs to track the tobacco product devices and will affect how the data are modeled. A tobacco product device can be identified as a single unit or its components can be separately identified. The level of granularity a sponsor chooses will be influenced by whether the components will be replaced and/or tracked, and how tobacco product device/adverse event relationships and actions taken will be assessed.

Example

This is an example of a study where the sponsor collected issues and events associated with the operation of the electronic cigarette product and any adverse events that a subject experienced as a result of the product issue or event.   

This form collects events and malfunctions associated with the operation of the tobacco product device.

CDASH EM Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	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
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 Terminology CodeList Name	Permissible Values	Pre-Populated Value
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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