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These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-121

TO provides a mechanism for uniquely identifying a tobacco product and is the source of the SPTOBID variable. For more information on this domain, see Section 3.1.1, Tobacco Product Identifiers and Descriptors. Only 1 tobacco product was of interest in the study.

Dataset wrap

Name	TO

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOVAL
1	TB123	TO	VAPE-Z01	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)
2	TB123	TO	VAPE-Z01	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	CLOSED E-CIGARETTE
3	TB123	TO	VAPE-Z01	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	XXX VAPES USA

These product malfunctions and events are represented in EM. Events not specifically associated with the product device should not be represented in this domain.

The applicant used a standardized or dictionary-derived text for the description of an issue or events. (Note: CDISC does not prescribe what standardized or dictionary-derived text should be used.) The applicant decided to use the International Medical Device Regulators Forum (IMDRF) document terminologies for categorized adverse event reporting for the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element (see Section 2.10, Standards for Data Exchange).

EMDECOD was the Level 3 IMDRF term. NSVs were used to represent the various coding level variables defined in the dictionary.

Example SUPPEM Variable Metadata

Variable	Label	Type	Codelist
EMIMDRCD	IMDRF Code	text	IMDRFANNEXA
EMIMDRFL2	IMDRF Level 2	text	IMDRFANNEXA
EMIMDRFL1	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

The SDTM EM dataset is shown below.

Dataset wrap

Name	EM

This is an example of a study were a heated stick and the associate device were used. The sponsor collected device events for the device and the actual heated stick as a single entity.

Show the same 3

characteristics used to create a device identifier (SPDEVID) for a second CGM.

Xformpusher

Order

CDASHIG Variable

Question Text

Prompt

Data Type

CRF Completion Instructions

SDTMIG Target

SDTM Variable Mapping

Controlled Terminology Codelist Name

CRF Implementation Notes

Permissible Values

Pre-populated Value

Query Display

List Style

Hidden

1

SPDEVID

What device experienced the event?

Device Experienced Event

text

Indicate the device that was involved in the incident.

SPDEVID

.

HEATED STICK DEVICE

radio

2

DESPID

What is the device event identifier?

Device Event Identifier

text

DESPID

Sequential number usually populated by the system for use in associated the event with other CRFs, e.g,. AE

Sponsor-defined

Y

6

DETERM

Describe the device event.

Device Event

text

Record a description of the device event that occurred.

DETERM

7

DESTDAT

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 format (DD-MON-YYYY).

DESTDTC

10

DEPATT

How frequently did the event occur?

Event Frequency

text

Record how often the incident occurred.

DEPATT

Single Event; Intermittent; Continuous

radio

11

DEACNDEV

What action was taken with or to study device?

Action Taken With Device

text

Record what action was taken with the device as a result of the incident.

DEACNDEV

(DEACNDEV)

No change; Device modified/adjusted; Device replaced; Removed temporarily; Removed

radio

12

DEAENO(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

Dataset wrap

Name	di

Rowcaps

Rows 1-4:

Show the 3 characteristics chosen to create the device identifier SPDEVID for a CGM. The DEVTYPE is required for all devices in DI; the manufacturer, model, together identify the device to the degree of granularity required in the study.

Rows 5-8:

Dataset2

Row	STUDYID	DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

TOB07

DI

01-ABC

1

DEVTYPE

Device Type

Mouthpiece

2

TOB07

DI

01-ABC

2

MANUF

Manufacturer

Reliable Devices

3

TOB07

DI

01-ABC

3

MODEL

Model Number

700XYZ

5

TOB07

DI

02-ABC

1

DEVTYPE

Device Type

Cartridge

6

TOB07

DI

02-ABC

2

MANUF

Manufacturer

ManF A Device

7

TOB07

DI

02-ABC

3

MODEL

Model Number

900 Tob

	USUBJID	SPTOBID	EMSEQ	EMLNKID	EMTERM	EMDECOD	EMMODIFY	EMACNDEV	EMPATT	EMSTDTC
1	TB123	EM	2029	VAPE-Z01	1		Broken Heater	Mechanical Problem	Mechanical Problem	DEVICE REPLACED	SINGLE	2009-12-28
2	TB123	EM	1059	VAPE-Z01	1		Won’t charge	Charging Problem	Charging Problem	BATTERY REPLACED	SINGLE	2009-01-05
3	TB123	EM	3067	VAPE-Z01	1	1	Battery Malfunction	Battery Problem	Battery Problem	BATTERY REPLACED	INTERMITTENT	2009-01-05

The SUPPEM dataset is used to represent the NSVs used for coding the malfunction or event. The parent domain (RDOMAIN) is EM, and IDVAR is EMSEQ. 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 (EMSEQ) equals the value specified in IDVARVAL.

Dataset wrap

Name	suppem

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	TB123	EM	2029	EMSEQ	1	EMIMDRCD	IMDR Code	AO5	ASSIGNED
2	TB123	EM	2029	EMSEQ	1	EMIMDRL2	IMDR Level 2	Mechanical Problem	ASSIGNED
3	TB123	EM	2029	EMSEQ	1	EMIMDRL1	IMDR Level 1	Mechanical Problem	ASSIGNED

In this study, subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below for brevity.

Dataset wrap

2009-01-05

Rowcaps

Row 1:

Shows a malfunction of an MRI calibration affecting 1 subject. In this case the individual MRI unit is not under study (e.g., when the MRI is used to obtain study measurements), and the sponsor decided to use the site number in SPDEVID.

Row 2:

Shows a malfunction of the device under study where all subjects for the day were affected. If this single record is sufficient detail for the sponsor’s requirements, then no further records would be added; if there were a need to associate the malfunction with each subject (e.g., it led to several AEs), then a record could be added for each affected subject. USUBJID is null because this device malfunction was not specific to one subject.

Row 3:

Shows a malfunction for a specific device under study and the associated subject.

Dataset2

Row	STUDYID	DOMAIN	USUBJID

SPDEVID

DESEQ

DETERM

DEDECOD

DECAT

DESEV

DEDTC

DESTDTC

1

ABC-123

DE

2022

Site 22

1

First calibration failed

Calibration failed

Calibration Failure

Minor

2010-01-01

2009-12-28

2

ABC-456

DE

15033

1

Data Loss

Data failure

Data Storage Failure

Major

2009-01-06

2009-01-05

3

ABC-789

DE

2222

334-XRS-09

1

Alignment Failure

Calibration failed

Calibration Failure

Major

2009-01-05

SPTOBID	AESEQ	AELNKID	AETERM	AERLDEV	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY
1	TB123	AE	3067	VAPE-Z01	1	1	SKIN REDNESS	RELATED	PRODUCT EXPOSURE	2009-01-05	2009-01-07	14	17

The RELREC dataset was used to record the relationship between the EM dataset and any reported AE represented in the AE dataset.

Expand

title	relrec.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	RELTYPE	RELID
1	TB005	EM		EMLNKID		ONE	AEEM1
2	TB005	AE		AELNKID		ONE	AEEM1

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