Tobacco Product Device Events (PI) Example 1

This is an example of a study were the sponsor collected events associated with the operation of the electronic cigarette device.

	Tobacco Product Identifier SPTOBID Pre-populated	VAPE-Z01
Record a description of the event that occurred.	What was the event associated with this tobacco product? PITERM	_________________
Record the date that the event first occurred or was noted using this format (DD-MON-YYYY).	What was the start date when the event first occurred or was identified? PISTDAT PISTDTC	_________________
Record how often the event occurred.	How frequently did the event occur? PIEPATT PIPATT	Single Event Intermittent Continuous
Record what action was taken with the tobacco product as a result of the event.	What action was taken with the study device? PIACNDEV	No Change Tobacco Product Replaced <DEACNDEV codelist>
Record the ID of the primary AE associated with event, if any.	What was the identifier for the primary adverse event(s) associated with or related to this device event? PIAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC	_________________

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	PITERM	What was the event associated with this tobacco product?	Tobacco Product Event	text	Record a description of the event that occurred.	PITERM
7	PISTDAT	What was the start date when the event first occurred or was identified?	Start Date	text	Record the date that the event first occurred or was noted using this format (DD-MON-YYYY).	PISTDTC
10	PIEPATT	How frequently did the event occur?	Event Frequency	text	Record how often the event occurred.	PIPATT			Single Event; Intermittent; Continuous		radio
11	PIACNDEV	What action was taken with the study device?	Action Taken With Device	text	Record what action was taken with the tobacco product as a result of the event.	PIACNDEV		(DEACNDEV)	No Change; Tobacco Product Replaced;		radio
12	PIAENO(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 event, if any.	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco.

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Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOSTRESC
1	TB005	PL	VAPE-Z01	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)	ENDS (VAPES)
2	TB005	PL	VAPE-Z01	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Closed E-Cigarette	Closed E-Cigarette
3	TB005	PL	VAPE-Z01	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	XX Vapes USA	XXX Vapes USA

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Sponsor may use standardized or dictionary-derived text for the description of an product device event/problem. CDISC does not provided information on the what standardized or dictionary-derived text should be used.

This sponsor decided to use the International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. PIDECODE was the Level 3 IMDRF term. The coding of the problems/events may be done using other methods/dictionaries.

( NOTE: Meta Example to be confirmed with RM.

Example SUPPPI Variable Metadata

Variable	Label	Type	Codelist
PIIMDRCD	IMDRF Code	text	IMDRFANNEXA
PIIMDRFL2	IMDRF Level 2	text	IMDRFANNEXA
PIIMDRFL1	IMDRF Level 1	text	IMDRFANNEXA

Example External Dictionaries

Codelist	External Dictionary Name	Dictionary Version	Reference
IMDRFANNEXA	IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes : Annex A	Release Number: 2022	https://www.imdrf.org/consultations/imdrf-terminologies-categorized-adverse-event-reporting-aer-terms-terminology-structure-and-codes

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Row	STUDYID	DOMAIN	USUBJID	SPTOBID	PISEQ	PILNKID	PITERM	PIDECOD	PIMODIFY	PIACT	PISTDTC	PIIMDRCD	PIIMDRL2	PIIMDRL1
1	TB005	PI	2029	VAPE-Z01	1		Broken Heater	Mechanical Problem	Mechanical Problem	Device Replaced	2009-12-28	A05	Mechanical Problem	Mechanical Problem
2	TB005	PI	1059	VAPE-Z01	1		Won’t charge	Charging Problem	Charging Problem	Battery Replaced	2009-01-05	A0706	Charging Problem	Electrical /Electronic Property Problem
3	TB005	PI	3067	VAPE-Z01	1	1	Battery Malfunction	Battery Problem	Battery Problem	Battery Replaced	2009-01-05	A0705	Battery Problem	Electrical /Electronic Property Problem

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PI NSV Metadata

Variable	Label	Type	Role	Origin
PIIMDRCD	IMDR Code	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
PIIMDRL2	IMDR Level 2	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
PIIMDRL1	IMDR Level 1	Char	Non-standard Variable Qualifier of DEDECOD	Assigned

This example illustrates how the coding information for a product issue might be represented. The parent domain (RDOMAIN) is PI, and IDVAR is PISEQ. QNAM holds the name of the supplemental qualifier variable being defined. This only shows the data for subject 2029. The data recorded in QVAL applies to the subject’s records, where IDVAR (PISEQ) equals the value specified in IDVARVAL.

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supppi.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	1996001	PI	2029	PISEQ	1	PIIMDRCD	IMDR Code	AO5	ASSIGNED
2	1996001	PI	2029	PISEQ	1	PIIMDRL2	IMDR Level 2	Mechanical Problem	ASSIGNED
3	1996001	PI	2029	PISEQ	1	PIIMDRL1	IMDR Level 1	Mechanical Problem	ASSIGNED

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Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity.

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Row	STUDYID	DOMAIN	USUBJID	AESEQ	AELNKID	AETERM	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY
1	TB005	AE	3067	1	1	SKIN REDNESS	STUDY PRODUCT ADMINSISTRATION	2009-01-05	2009-01-07	14	18

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The RELREC dataset was used to record the relationship between the Product Events in PI and reported AE represented in AE dataset.

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	TB005	PI		PILNKID		ONE	AEPI1
2	TB005	AE		AELNKID		ONE	AEPI

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Tobacco Product Device Events (PI) Example 1