SDTM Example.Product HPHC ENDS Testing

Tobacco product HPHC testing results are represented in the PT domain. This example assume testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Stability Studies section for more information and examples on handling those data.

HPHC testing is conducted on samples of the product of interest, and (if applicable) samples of comparison products. Each product tested would have its own unique sponsor-defined value for SPTOBID to identify the product.

This example only shows test results for each constituent for one replicate of one sample of one product that was tested. Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor or by regulatory requirement. Sponsors would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset.

The following references were used as guidance for the example below:
1. https://www.ecigstats.org/docs/research/CoA_1R6F.pdf
2. https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345

Rows 1-17:	Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition is represented in STOCONID.
Rows 5-6:	Show the same analyte from two different sources
Rows 14-16:	Show three analytes that were tested in smoke produced by a smoking machine. SPDEVID indicates the smoking machine identified in the DI dataset example below. The smoking regimen is shown in PTREFID. The parameters of the smoking regimen are represented in the DU domain (example below) and are matched by using the same value of DUREFID). Note that PTSPEC (Matrix Type) is "SMOKE" for these 3 records (vs "TOBACCO") for all other records in this dataset.
Rows 18-19:	Show the HPHC testing performed on one sample for two ingredients using the CANDIAN INTENSE test conditions. Row 18 Specimen is Smoke and Row 19 Specimen is Filler.

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pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	PTSEQ	PTREFID	PTCAS	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTMETHOD	PTREPNUM	PTTPT	PTTPTNUM	PTDTC
1	TOB07	PT	CIG01a		8		71-43-2	BENZN	Benzene	HPHC TESTING	HPHC	33	µg/cigarette	33	33	µg/cigarette	TOBACCO	ISO METHOD	1	Week 0	1	2022-09-30
2	TOB07	PT	CIG01a		9		50-32-8	BENZOAP	Benzo[a]pyrene	HPHC TESTING	HPHC	6.8	ng/cigarette	6.8	6.8	ng/cigarette	TOBACCO	ISO METHOD	1	Week 0	1	2022-09-30
3
4	TOB07	PT	CIG01a	PUFFMASTER3K	15	Medium Intensity Regimen	64091-91-4	NNK	Nicotine-Derived Nitrosamine Ketone	HPHC TESTING	HPHC	71	ng/cigarette	71	71	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
5	TOB07	PT	CIG01a	PUFFMASTER3K	16	Medium Intensity Regimen	16543-55-8	NNN	N-nitrosonornicotine	HPHC TESTING	HPHC	85	ng/cigarette	85	85	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
6
7	STUDYID	DOMAIN	SPTOBID		PTSEQ	PTREFID	PTCSREFID	PTTESTCD	PTTEST	PTCAT	HPHC vs other constituents	PTORRES	Unit	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTMETHOD	PTREPNUM	PTTPT	PTTPTNUM	PTDTC
8											PTSCAT		PTORRESU				PTMETHOD			Week 0	1
9							1954-11-05	NIC	Nicotine	HPHC TESTING		3	mg/mL	3	3	mg/mL	TL001 v3	-	1	Week 0	1	2022-09-30
10											HPHC
11	TOB08	PT	ENDS02a		1	Batch 101	75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	7.9	µg/mL	7.9	7.9	µg/mL	TL- 201 v4.2	-	1	Week 0	1	2022-09-30
12				PUFFMASTER3K			1954-11-05	NIC	Nicotine	HPHC TESTING	HPHC	53.5	µg/puff	53.5	53.5	µg/puff	TL -544 v 3.1	Non-intense	1	Week 0	1	2022-09-30
13	TOB08	PT	ENDS02a	PUFFMASTER3K	2	Batch 101	75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	34.7	ng/puff	34.7	34.7	ng/puff		Non-intense	1			2022-09-30
14				PUFFMASTER3K					Benzoic Acid	HPHC TESTING	Other	43.3	µg/puff	43.3	43.3	µg/puff		Non-intense	1			2022-09-30
15				PUFFMASTER3K			1954-11-05	NIC	Nicotine	HPHC TESTING	HPHC	105	µg/puff	105	105	µg/puff		Intense	1			2022-09-30
16	TOB08	PT	ENDS02a	PUFFMASTER3K	2	Batch 101	75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	43.5	ng/puff	43.5	43.5	ng/puff		Intense	1			2022-09-30
17				PUFFMASTER3K					Benzoic Acid	HPHC TESTING	Other	84.1	µg/puff	84.1	84.1	µg/puff		Intense	1			2022-09-30

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The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset.

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	Smoking Machine
2	TOB07	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme
3	TOB07	DI	PUFFMASTER3K	3	TRADENAM	Trade Name	PuffMaster 3000

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Details of the smoking regimen performed by the smoking machine are represented as device in-use properties, linked to the HPHC testing results in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen".

du.xpt

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	Medium Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	Medium Intensity Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	Medium Intensity Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	Medium Intensity Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	Medium Intensity Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	Medium Intensity Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	Medium Intensity Regimen		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	Medium Intensity Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	Medium Intensity Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

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SDTM Example.Product HPHC ENDS Testing