SDTM Example. ENDS Design Parameters

THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset

https://www.sciencedirect.com/science/article/pii/S004060311930752X

This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

Rows 1-4:	Show the records for a tobacco product given SPTOBID of VAPE-Z27.
Rows 1-3:	Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:	Show the package type is a Box that contains 1 E-Cigarettes that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-12:	Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 13-15:	Show the attributes or characteristics of the heating element for the E-cigarette .

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU	TOSTRESC	TOSTRESN	TOSTRESU
1	TOB09	TO	VAPE-Z27	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)		ENDS (VAPES)
2	TOB09	TO	VAPE-Z27	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Closed E-Cigarette		Closed E-Cigarette
3	TOB09	TO	VAPE-Z27	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Vapes USA		Joes Vapes USA
4	TOB09	TO	VAPE-Z27	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Everyday Rich Tobacco		Everyday Rich Tobacco
5	TOB09	TO	VAPE-Z27	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	BOX		BOX
6	TOB09	TO	VAPE-Z27	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	1	E-CIGARETTE	1	1	E-CIGARETTE
7	TOB09	TO	VAPE-Z27	7	LENGTH	Length	PRODUCT DESCRIPTOR	107.2	mm	107.2	107.2	mm
8	TOB09	TO	VAPE-Z27	8	DIAMETER	Diameter	PRODUCT DESCRIPTOR	9	mm	9	9	mm
9	TOB09	TO	VAPE-Z27	9	NICTNCNC	Nicotine Concentration	PRODUCT DESCRIPTOR	2	mg/L	2	2	mg/L
10	TOB09	TO	VAPE-Z27	10	PGVGRT	PG/VG Ratio*	PRODUCT DESCRIPTOR	50/50		50/50	50/50
11	TOB09	TO	VAPE-Z27	11	CHTRFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	TOBACCO		TOBACCO	TOBACCO
12	TOB09	TO	VAPE-Z27	12	VOLUMEE	Volume, E-liquid	PRODUCT DESCRIPTOR	1	mL	1	1	mL
13	TOB09	TO	VAPE-Z27	13	WATT	Wattage	PRODUCT DESCRIPTOR	5.2	Watt	5.2	5.2	Watt
14	TOB09	TO	VAPE-Z27	14	BATTCAP	Battery Capacity	PRODUCT DESCRIPTOR	600	mAh	600	600	mAh
15	TOB09	TO	VAPE-Z27	15	DISPCRTG	Disposable Cartridge	PRODUCT DESCRIPTOR	Y		Y	Y

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The ~~Tobacco~~ Design Parameters (PD) is similar to the Device Properties (DO) domain represents properties of the tobacco product that do not vary over the life of the product. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TPTESTCD/TPTEST.

Rows 1-94:	Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 80-82:	Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU	PDCOLSRT
1	TOB09	PD	VAPE-Z27	1	DRWRST	Draw Resistance	90.0	80.0	120.0	mm H2O	TARGET
2	TOB09	PD	VAPE-Z27	4	PUFCNT	Puff count (for full tank/cartridge)	7	3	11	NUMBER COUNT	TARGET
3	TOB09	PD	VAPE-Z27	7	CRTVOL	Cartridge volume	3	1	5	mL	TARGET
4	TOB09	PD	VAPE-Z27	10	HTELNUM	Number of heating elements	1	1	1	NUMBER COUNT	TARGET
5	TOB09	PD	VAPE-Z27	13	HTELGTH	Heating element length	3	2	4	mm	TARGET
6	TOB09	PD	VAPE-Z27	16	HTEDIAM	Heating element diameter	3	2	5	mm	TARGET
7	TOB09	PD	VAPE-Z27	19	HTELRST	Heating element resistance	0.75	0.25	1.5	ohm	TARGET
8	TOB09	PD	VAPE-Z27	22	HTELRNG	Heating element range	175	100	250	C	TARGET
9	TOB09	PD	VAPE-Z27	25	HTELCFG	Heating element configuration	SPIRAL	SPIRAL	SPIRAL		TARGET
10	TOB09	PD	VAPE-Z27	26	BTVLTORG	Battery voltage operating range	4.5	3	6	V	TARGET
11	TOB09	PD	VAPE-Z27	29	BTCRTORG	Battery current operating range	1000	650	1600	mAh	TARGET
12	TOB09	PD	VAPE-Z27	32	BATCAPC	Battery capacity	1100	800	3000	mAh	TARGET
13	TOB09	PD	VAPE-Z27	35	BATNOMV	Battery nominal voltage	4.2	4.0	4.5	V	TARGET
14	TOB09	PD	VAPE-Z27	38	BTCRTRT	Battery Current Rating	2500	2000	2800	mA	TARGET
15	TOB09	PD	VAPE-Z27	41	BTCHTPL	Battery Charging Temperature Limits	200	100	315	C	TARGET
16	TOB09	PD	VAPE-Z27	44	BTDCTMPL	Battery Discharge Temperature Limits	20	-20	60	C	TARGET
17	TOB09	PD	VAPE-Z27	47	BTENDCV	Battery end of discharge voltage	3.0	2.0	3.5	V	TARGET
18	TOB09	PD	VAPE-Z27	50	BTMXCHC	Battery maximum charging current	24	20	30	mA	TARGET
19	TOB09	PD	VAPE-Z27	53	BTMXDCC	Battery maximum discharging current	2700	2400	3000	mA	TARGET
20	TOB09	PD	VAPE-Z27	56	BTULCHV	Battery upper limits charging voltage	4.2	4.1	4.3	V	TARGET
21	TOB09	PD	VAPE-Z27	59	PDUVOR	Power Delivery Unit (PDU) voltage operating range	3.7	3.2	4.2	V	TARGET
22	TOB09	PD	VAPE-Z27	62	PDUCOR	PDU current operating range	1200	850	1800	mA	TARGET
23	TOB09	PD	VAPE-Z27	65	PDUWTOR	PDU wattage operating range	75	70	80	W	TARGET
24	TOB09	PD	VAPE-Z27	68	PDUTCTOF	PDU temperature cut-off (if applicable)	70	55	65	C	TARGET
25	TOB09	PD	VAPE-Z27	71	AIRFLRT	Airflow rate				L/min	TARGET
26	TOB09	PD	VAPE-Z27	74	PDUCRCOF	PDU current cut-off (if applicable)				mA	TARGET
27	TOB09	PD	VAPE-Z27	77	INHAERT	Inhaled aerosol temperature				C	TARGET
28	TOB09	PD	VAPE-Z27	80	VENTLTN	Ventilation				%	TARGET
29	TOB09	PD	VAPE-Z27	83	ELQDVISC	E-Liquid viscosity					TARGET
30	TOB09	PD	VAPE-Z27	86	ELQDVOL	E-liquid volume				mL	TARGET
31	TOB09	PD	VAPE-Z27	89	PNUMCNC	Particle number concentration				#/cm³	TARGET
32	TOB09	PD	VAPE-Z27	92	CTMDDIAM	Count median diameter				nm	TARGET
33	TOB09	PD	VAPE-Z27	95	PM	PM 2.5				ug/m³	TARGET

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*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio

The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).

Rows 1-32:	Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:	Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTTSTCND	PTCAT	PTORRESU	PTSTRESU	PTREPNUM	PTTPT	PTTPTNUM
1	TOB09	PT	VAPE-Z27	1	DRWRST	Draw Resistance		DESIGN PARAMETER SPECIFICATION TEST RESULT	mm H2O	mm H2O	1	Week 0	1
2	TOB09	PT	VAPE-Z27	2	PUFCNT	Puff count (for full tank/cartridge)		DESIGN PARAMETER SPECIFICATION TEST RESULT	NUMBER COUNT	NUMBER COUNT	1	Week 0	1
3	TOB09	PT	VAPE-Z27	3	CRTVOL	Cartridge volume		DESIGN PARAMETER SPECIFICATION TEST RESULT	mL	mL	1	Week 0	1
4	TOB09	PT	VAPE-Z27	4	HTELNUM	Number of heating elements		DESIGN PARAMETER SPECIFICATION TEST RESULT	NUMBER COUNT	NUMBER COUNT	1	Week 0	1
5	TOB09	PT	VAPE-Z27	5	HTELGTH	Heating element length		DESIGN PARAMETER SPECIFICATION TEST RESULT	mm	mm	1	Week 0	1
6	TOB09	PT	VAPE-Z27	6	HTELRST	Heating element resistance		DESIGN PARAMETER SPECIFICATION TEST RESULT	ohm	ohm	1	Week 0	1
7	TOB09	PT	VAPE-Z27	7	HTELRNG	Heating element range		DESIGN PARAMETER SPECIFICATION TEST RESULT	C	C	1	Week 0	1
8	TOB09	PT	VAPE-Z27	8	HTELCFG	Heating element configuration		DESIGN PARAMETER SPECIFICATION TEST RESULT			1	Week 0	1
9	TOB09	PT	VAPE-Z27	9	BTVLTORG	Battery voltage operating range		DESIGN PARAMETER SPECIFICATION TEST RESULT	V	V	1	Week 0	1
10	TOB09	PT	VAPE-Z27	10	BTCRTORG	Battery current operating range		DESIGN PARAMETER SPECIFICATION TEST RESULT	mAh	mAh	1	Week 0	1
11	TOB09	PT	VAPE-Z27	11	BATCAPC	Battery capacity		DESIGN PARAMETER SPECIFICATION TEST RESULT	mAh	mAh	1	Week 0	1
12	TOB09	PT	VAPE-Z27	12	BATNOMV	Battery nominal voltage		DESIGN PARAMETER SPECIFICATION TEST RESULT	V	V	1	Week 0	1
13	TOB09	PT	VAPE-Z27	13	BTCRTRT	Battery Current Rating		DESIGN PARAMETER SPECIFICATION TEST RESULT	mA		1	Week 0	1
14	TOB09	PT	VAPE-Z27	14	BTCHTPL	Battery Charging Temperature Limits		DESIGN PARAMETER SPECIFICATION TEST RESULT	C		1	Week 0	1
15	TOB09	PT	VAPE-Z27	15	BTDCTMPL	Battery Discharge Temperature Limits		DESIGN PARAMETER SPECIFICATION TEST RESULT	C		1	Week 0	1
16	TOB09	PT	VAPE-Z27	16	BTENDCV	Battery end of discharge voltage		DESIGN PARAMETER SPECIFICATION TEST RESULT	V		1	Week 0	1
17	TOB09	PT	VAPE-Z27	17	BTMXCHC	Battery maximum charging current		DESIGN PARAMETER SPECIFICATION TEST RESULT	mA		1	Week 0	1
18	TOB09	PT	VAPE-Z27	18	BTMXDCC	Battery maximum discharging current		DESIGN PARAMETER SPECIFICATION TEST RESULT	mA		1	Week 0	1
19	TOB09	PT	VAPE-Z27	19	BTULCHV	Battery upper limits charging voltage		DESIGN PARAMETER SPECIFICATION TEST RESULT	V		1	Week 0	1
20	TOB09	PT	VAPE-Z27	20	PDUVOR	Power Delivery Unit (PDU) voltage operating range		DESIGN PARAMETER SPECIFICATION TEST RESULT	V		1	Week 0	1
21	TOB09	PT	VAPE-Z27	21	PDUCOR	PDU current operating range		DESIGN PARAMETER SPECIFICATION TEST RESULT	mA		1	Week 0	1
22	TOB09	PT	VAPE-Z27	22	PDUWTOR	PDU wattage operating range		DESIGN PARAMETER SPECIFICATION TEST RESULT	W		1	Week 0	1
23	TOB09	PT	VAPE-Z27	23	PDUTCTOF	PDU temperature cut-off (if applicable)		DESIGN PARAMETER SPECIFICATION TEST RESULT	C		1	Week 0	1
24	TOB09	PT	VAPE-Z27	24	AIRFLRT	Airflow rate		DESIGN PARAMETER SPECIFICATION TEST RESULT	L/min		1	Week 0	1
25	TOB09	PT	VAPE-Z27	25	PDUCRCOF	PDU current cut-off (if applicable)		DESIGN PARAMETER SPECIFICATION TEST RESULT	mA		1	Week 0	1
26	TOB09	PT	VAPE-Z27	26	INHAERT	Inhaled aerosol temperature		DESIGN PARAMETER SPECIFICATION TEST RESULT	C		1	Week 0	1
27	TOB09	PT	VAPE-Z27	27	VENTLTN	Ventilation		DESIGN PARAMETER SPECIFICATION TEST RESULT	%		1	Week 0	1
28	TOB09	PT	VAPE-Z27	28	ELQDVISC	E-Liquid viscosity	Test performed at 20 degrees Celsius	DESIGN PARAMETER SPECIFICATION TEST RESULT			1	Week 0	1
29	TOB09	PT	VAPE-Z27	29	ELQDVOL	E-liquid volume		DESIGN PARAMETER SPECIFICATION TEST RESULT	mL		1	Week 0	1
30	TOB09	PT	VAPE-Z27	30	PNUMCNC	Particle number concentration		DESIGN PARAMETER SPECIFICATION TEST RESULT	#/cm³		1	Week 0	1
31	TOB09	PT	VAPE-Z27	31	CTMDDIAM	Count median diameter		DESIGN PARAMETER SPECIFICATION TEST RESULT	nm		1	Week 0	1
32	TOB09	PT	VAPE-Z27	32	PM	PM 2.5		DESIGN PARAMETER SPECIFICATION TEST RESULT	ug/m³		1	Week 0	1

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SDTM Example. ENDS Design Parameters