SDTM Example. ENDS Design Parameters

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

The following example illustrates the representation of ENDS tobacco product identifiers and descriptors using the TO domain. Note that this example makes use of TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOVAL	TOVALU
1	TOB09	TO	VAPE-Z27	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)
2	TOB09	TO	VAPE-Z27	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Closed E-Cigarette
3	TOB09	TO	VAPE-Z27	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Vapes USA
4	TOB09	TO	VAPE-Z27	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Everyday Rich Tobacco
5	TOB09	TO	VAPE-Z27	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	BOX
6	TOB09	TO	VAPE-Z27	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	1	E-CIGARETTE
7	TOB09	TO	VAPE-Z27	7	LENGTH	Length	PRODUCT DESCRIPTOR	107.2	mm
8	TOB09	TO	VAPE-Z27	8	DIAMETER	Diameter	PRODUCT DESCRIPTOR	9	mm
9	TOB09	TO	VAPE-Z27	9	NICTNCNC	Nicotine Concentration	PRODUCT DESCRIPTOR	2	mg/L
10	TOB09	TO	VAPE-Z27	10	PG	Propylene Glycol	PRODUCT DESCRIPTOR	50	%
11	TOB09	TO	VAPE-Z27	11	VG	Vegetable Glycerin	PRODUCT DESCRIPTOR	50	%
12	TOB09	TO	VAPE-Z27	12	CHTRFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	TOBACCO
13	TOB09	TO	VAPE-Z27	13	VOLUMEE	Volume, E-liquid	PRODUCT DESCRIPTOR	1	mL
14	TOB09	TO	VAPE-Z27	14	WATT	Wattage	PRODUCT DESCRIPTOR	5.2	Watt
15	TOB09	TO	VAPE-Z27	15	BATTCAP	Battery Capacity	PRODUCT DESCRIPTOR	600	mAh
16	TOB09	TO	VAPE-Z27	16	DISPCRTG	Disposable Cartridge	PRODUCT DESCRIPTOR	Y

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The manufacturing parameter specifications of the ENDS product as intended for used are represented in the Product Design Parameters (PD) domain. The example below shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB09	PD	VAPE-Z27	1	DRWRST	Draw Resistance	90.0	80.0	120.0	mm H2O
2	TOB09	PD	VAPE-Z27	2	PUFCNT	Puff Count	300	290	310
3	TOB09	PD	VAPE-Z27	3	CRTVOL	Cartridge Volume	3	1	5	mL
4	TOB09	PD	VAPE-Z27	4	HTELNUM	Number of Heating Elements	1	1	1
5	TOB09	PD	VAPE-Z27	5	HTELGTH	Heating Element Length	3	2.7	3.3	mm
6	TOB09	PD	VAPE-Z27	6	HTEDIAM	Heating Element Diameter	3	2.9	3.2	mm
7	TOB09	PD	VAPE-Z27	7	HTELRST	Heating Element Resistance	0.75	0.25	1.5	ohm
8	TOB09	PD	VAPE-Z27	8	HTELRNG	Heating Element Range	175	100	250	C
9	TOB09	PD	VAPE-Z27	9	HTELCFG	Heating Element Configuration	SPIRAL	SPIRAL	SPIRAL
10	TOB09	PD	VAPE-Z27	10	BTVLTORG	Battery Voltage Operating Range	4.5	3	6	V
11	TOB09	PD	VAPE-Z27	11	BTCRTORG	Battery Current Operating Range	1000	650	1600	mAh
12	TOB09	PD	VAPE-Z27	12	BATCAPC	Battery Capacity	1100	800	3000	mAh
13	TOB09	PD	VAPE-Z27	13	BATNOMV	Battery Nominal Voltage	4.2	4.0	4.5	V
14	TOB09	PD	VAPE-Z27	14	BTCRTRT	Battery Current Rating	2500	2000	2800	mA
15	TOB09	PD	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits	200	100	315	C
16	TOB09	PD	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits	20	-20	60	C
17	TOB09	PD	VAPE-Z27	17	BTENDCV	Battery End of Discharge Voltage	3.0	2.0	3.5	V
18	TOB09	PD	VAPE-Z27	18	BTMXCHC	Battery Maximum Charging Current	24	20	30	mA
19	TOB09	PD	VAPE-Z27	19	BTMXDCC	Battery Maximum Discharging Current	2700	2400	3000	mA
20	TOB09	PD	VAPE-Z27	20	BTULCHV	Battery Upper Limits Charging Voltage	4.2	4.1	4.3	V
21	TOB09	PD	VAPE-Z27	21	PDUVOR	PDU Voltage Operating Range	3.7	3.2	4.2	V
22	TOB09	PD	VAPE-Z27	22	PDUCOR	PDU Current Operating Range	1200	850	1800	mA
23	TOB09	PD	VAPE-Z27	23	PDUWTOR	PDU Wattage Operating Range	75	70	80	W
24	TOB09	PD	VAPE-Z27	24	PDUTCTOF	PDU Temperature Cut-off	70	55	65	C
25	TOB09	PD	VAPE-Z27	25	AIRFLRT	Airflow Rate	720	700	740	L/min
26	TOB09	PD	VAPE-Z27	26	PDUCRCOF	PDU Current Cut-off	35	20	50	mA
27	TOB09	PD	VAPE-Z27	27	INHAERT	Inhaled Aerosol Temperature	37	35	40	C
28	TOB09	PD	VAPE-Z27	28	VENTLTN	Ventilation	50	40	60	%
29	TOB09	PD	VAPE-Z27	29	ELQDVISC	E-Liquid Viscosity	500	75	1130	mPa/s
30	TOB09	PD	VAPE-Z27	30	ELQDVOL	E-liquid Volume	60	10	120	mL
31	TOB09	PD	VAPE-Z27	31	PNUMCNC	Particle Number Concentration	500	108	1010	/cm3
32	TOB09	PD	VAPE-Z27	32	CTMDDIAM	Count Median Diameter	200	150	250	nm
33	TOB09	PD	VAPE-Z27	33	PM	PM 2.5	25	12	35	ug/m3

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Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTTSTCND	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM	PTTPT	PTTPTNUM
1	TOB09	PT	VAPE-Z27	1	DRWRST	Draw Resistance		DESIGN PARAMETER TESTING	91	mm H2O	91	91	mm H2O	1	Week 0	1
2	TOB09	PT	VAPE-Z27	2	PUFCNT	Puff Count		DESIGN PARAMETER TESTING	309		309	309		1	Week 0	1
3	TOB09	PT	VAPE-Z27	3	CRTVOL	Cartridge Volume		DESIGN PARAMETER TESTING	3.09	mL	3.09	3.09	mL	1	Week 0	1
4	TOB09	PT	VAPE-Z27	4	HTELNUM	Number of Heating Elements		DESIGN PARAMETER TESTING	1		1	1		1	Week 0	1
5	TOB09	PT	VAPE-Z27	5	HTELGTH	Heating Element Length		DESIGN PARAMETER TESTING	2.97	mm	2.97	2.97	mm	1	Week 0	1
6	TOB09	PT	VAPE-Z27	6	HTEDIAM	Heating Element Diameter		DESIGN PARAMETER TESTING	3.05	mm	3.05	3.05	mm
7	TOB09	PT	VAPE-Z27	7	HTELRST	Heating Element Resistance		DESIGN PARAMETER TESTING	0.77	ohm	0.77	0.77	ohm	1	Week 0	1
8	TOB09	PT	VAPE-Z27	8	HTELRNG	Heating Element Range		DESIGN PARAMETER TESTING	174	C	174	174	C	1	Week 0	1
9	TOB09	PT	VAPE-Z27	9	HTELCFG	Heating Element Configuration		DESIGN PARAMETER TESTING	SPIRAL		SPIRAL	SPIRAL		1	Week 0	1
10	TOB09	PT	VAPE-Z27	10	BTVLTORG	Battery Voltage Operating Range		DESIGN PARAMETER TESTING	4.6	V	4.6	4.6	V	1	Week 0	1
11	TOB09	PT	VAPE-Z27	11	BTCRTORG	Battery Current Operating Range		DESIGN PARAMETER TESTING	997	mAh	997	997	mAh	1	Week 0	1
12	TOB09	PT	VAPE-Z27	12	BATCAPC	Battery Capacity		DESIGN PARAMETER TESTING	1112	mAh	1112	1112	mAh	1	Week 0	1
13	TOB09	PT	VAPE-Z27	13	BATNOMV	Battery Nominal Voltage		DESIGN PARAMETER TESTING	4.18	V	4.18	4.18	V	1	Week 0	1
14	TOB09	PT	VAPE-Z27	14	BTCRTRT	Battery Current Rating		DESIGN PARAMETER TESTING	2488	mA	2488	2488	mA	1	Week 0	1
15	TOB09	PT	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits		DESIGN PARAMETER TESTING	198	C	198	198	C	1	Week 0	1
16	TOB09	PT	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits		DESIGN PARAMETER TESTING	19	C	19	19	C	1	Week 0	1
17	TOB09	PT	VAPE-Z27	17	BTENDCV	Battery End of Discharge Voltage		DESIGN PARAMETER TESTING	3.03	V	3.03	3.03	V	1	Week 0	1
18	TOB09	PT	VAPE-Z27	18	BTMXCHC	Battery Maximum Charging Current		DESIGN PARAMETER TESTING	23.5	mA	23.5	23.5	mA	1	Week 0	1
19	TOB09	PT	VAPE-Z27	19	BTMXDCC	Battery Maximum Discharging Current		DESIGN PARAMETER TESTING	2696	mA	2696	2696	mA	1	Week 0	1
20	TOB09	PT	VAPE-Z27	20	BTULCHV	Battery Upper Limits Charging Voltage		DESIGN PARAMETER TESTING	4.21	V	4.21	4.21	V	1	Week 0	1
21	TOB09	PT	VAPE-Z27	21	PDUVOR	PDU Voltage Operating Range		DESIGN PARAMETER TESTING	3.65	V	3.65	3.65	V	1	Week 0	1
22	TOB09	PT	VAPE-Z27	22	PDUCOR	PDU Current Operating Range		DESIGN PARAMETER TESTING	1202	mA	1202	1202	mA	1	Week 0	1
23	TOB09	PT	VAPE-Z27	23	PDUWTOR	PDU Wattage Operating Range		DESIGN PARAMETER TESTING	75	W	75	75	W	1	Week 0	1
24	TOB09	PT	VAPE-Z27	24	PDUTCTOF	PDU Temperature Cut-off		DESIGN PARAMETER TESTING	69.9	C	69.9	69.9	C	1	Week 0	1
25	TOB09	PT	VAPE-Z27	25	AIRFLRT	Airflow Rate		DESIGN PARAMETER TESTING	727	L/min	727	727	L/min	1	Week 0	1
26	TOB09	PT	VAPE-Z27	26	PDUCRCOF	PDU Current Cut-off		DESIGN PARAMETER TESTING	34.8	mA	34.8	34.8	mA	1	Week 0	1
27	TOB09	PT	VAPE-Z27	27	INHAERT	Inhaled Aerosol Temperature		DESIGN PARAMETER TESTING	36.9	C	36.9	36.9	C	1	Week 0	1
28	TOB09	PT	VAPE-Z27	28	VENTLTN	Ventilation		DESIGN PARAMETER TESTING	51	%	51	51	%	1	Week 0	1
29	TOB09	PT	VAPE-Z27	29	ELQDVISC	E-Liquid Viscosity	Test performed at 20 degrees Celsius	DESIGN PARAMETER TESTING	496	mPa/s	496	496	mPa/s	1	Week 0	1
30	TOB09	PT	VAPE-Z27	30	ELQDVOL	E-liquid Volume		DESIGN PARAMETER TESTING	60.1	mL	60.1	60.1	mL	1	Week 0	1
31	TOB09	PT	VAPE-Z27	31	PNUMCNC	Particle Number Concentration		DESIGN PARAMETER TESTING	511	/cm3	511	511	/cm3	1	Week 0	1
32	TOB09	PT	VAPE-Z27	32	CTMDDIAM	Count Median Diameter		DESIGN PARAMETER TESTING	202	nm	202	202	nm	1	Week 0	1
33	TOB09	PT	VAPE-Z27	33	PM	PM 2.5		DESIGN PARAMETER TESTING	24.4	ug/m3	24.4	24.4	ug/m3	1	Week 0	1

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SDTM Example. ENDS Design Parameters