SDTM Example.Product HPHC Testing

Tobacco product HPHC testing study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. The details of the regimen and storage conditions are shown in separate datasets that follow this example.

The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.
PTCAT represents the type of testing such as HPHC Testing or Design Parameter Testing
PTSCAT represents HPHC vs other constituents

https://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.

This testing is conducted on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product.

https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345

This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset.

Question for team

Is it important to show the same analyte from two different plants? - See rows 5 and 6.

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 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.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	STOCONID	PTSEQ	PTREFID	PTCAS	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTMETHOD	PTREPNUM	PTTPT	PTTPTNUM	PTDTC
1	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	1		75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	522	µg/cigarette	522	522	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
2	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	2		107-02-8	ACROL	Acrolein	HPHC TESTING	HPHC	43	µg/cigarette	43	43	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
3	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	3		107-13-1	ACRLONI	Acrylonitrile	HPHC TESTING	HPHC	7	µg/cigarette	7	7	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
4	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	4		92-67-1	AMNPHEN4	4-Aminobiphenyl	HPHC TESTING	HPHC	1.2	ng/cigarette	1.2	1.2	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
5	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	5		134-32-7	AMNPHTH1	1-Aminonaphthalene	HPHC TESTING	HPHC	14	ng/cigarette	14	14	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
6	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	6		134-32-7	AMNPHTH2	2-Aminonaphthalene	HPHC TESTING	HPHC	8	ng/cigarette	8	8	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
7	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	7		7664-41-7	NH4	Ammonia	HPHC TESTING	HPHC	9	µg/cigarette	9	9	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
8	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	8		71-43-2	BENZ	Benzene	HPHC TESTING	HPHC	33	µg/cigarette	33	33	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
9	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	9		50-32-8	BENZAP	Benzo[a]pyrene	HPHC TESTING	HPHC	6.8	ng/cigarette	6.8	6.8	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
10	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	10		630-08-0	CO	Carbon monoxide	HPHC TESTING	HPHC	10.1	mg/cigarette	10.1	10.1	mg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
11	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	11		4170-30-3	CROTALD	Crotonaldehyde	HPHC TESTING	HPHC	11	µg/cigarette	11	11	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
12	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	12		50-00-0	FORMALD	Formaldehyde	HPHC TESTING	HPHC	27	µg/cigarette	27	27	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
13	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	13		78-79-5	ISOPRN	Isoprene	HPHC TESTING	HPHC	320	µg/cigarette	320	320	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
14	TOB07	PT	CIG01a	PUFFMASTER3K	E-Liquid Standard (Long Term) Condition	14	Medium Intensity Regimen	1954-11-05	NIC	Nicotine	HPHC TESTING	HPHC	0.721	mg/cigarette	0.721	0.721	mg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
15	TOB07	PT	CIG01a	PUFFMASTER3K	E-Liquid Standard (Long Term) Condition	15	Medium Intensity Regimen	64091-91-4	NNK	4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone	HPHC TESTING	HPHC	71	ng/cigarette	71	71	ng/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
16	TOB07	PT	CIG01a	PUFFMASTER3K	E-Liquid Standard (Long Term) Condition	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
17	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	17		108-88-3		Toluene	HPHC TESTING	HPHC	53	µg/cigarette	53	53	µg/cigarette	SMOKE	ISO METHOD	1	Week 0	1	2022-09-30
18	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	18		75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	1552	µg/cigarette	1552	1552	µg/cigarette	SMOKE	CANADIAN INTENSE METHOD	1	Week 0	1	2022-09-30
19	TOB07	PT	CIG01a		E-Liquid Standard (Long Term) Condition	19		7664-41-7	AMMONIA	Ammonia	HPHC TESTING	HPHC	956	µg/g	956	956	µg/cigarette	FILLER	CANADIAN INTENSE METHOD	1	Week 0	1	2022-09-30

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Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).

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 are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).

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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Finally, we assume we still need to parse out storage conditions of "E-Liquid Standard (Long Term) Condition". Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.

The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
These values were made up, but we assume they'd look something like this.

es.xpt

Row	STUDYID	DOMAIN	STOCONID	ESSEQ	ESPARMCD	ESPARM	ESVAL	ESVALU
1	TOB07	ES	E-Liquid Standard (Long Term) Condition	1	HUMID	Humidity	38	%
2	TOB07	ES	E-Liquid Standard (Long Term) Condition	2	TEMP	Temperature	25	C

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SDTM Example.Product HPHC Testing