SDTM Example.Product HPHC ENDS Testing

HPHC testing

Aerosol data used data from: https://www.mdpi.com/2297-8739/8/10/168/htm was from a 3% nicotine solution.

Data for acetaldehyde in solution from Chemical evaluation of electronic cigarettes | Tobacco Control (bmj.com), calculation below

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 1-2:	Show the HPHC testing performed for two constituents on Batch 1, Replication 1 for the liquid matrix. The CAS number of the constituent is provided in PTCAS.
Rows 3-5:	Shows the HPHC testing performed for three constituents using the NON-INTENSE SMOKING REGIME for BATCH 1 and Replicate 1.
Rows 6-7:	Shows the HPHC testing performed for three constituents using the INTENSE SMOKING REGIME for BATCH 1 and Replicate 1.

Row Captions Debug Message

Remember to keep number agreement between labels and captions.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	PTSEQ	PTREFID	PTSPID	PTCAS	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTMETHOD	PTREPNUM	PTDTC
1	TOB08	PT	ENDS02a		1	Batch 101	since we started with using PTREFID for the Smoking Regimen in the Cig. example, The batch number could go here. It seems like Smoking Regimen is a method though.	75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	7.9	µg/mL	7.9	7.9	µg/mL	E-LIQUID		1	2022-09-30
2	TOB08	PT	ENDS02a	PUFFMASTER3K	2	Batch 101		1954-11-05	NIC	Nicotine	HPHC TESTING	HPHC	53.5	µg/puff	53.5	53.5	µg/puff	AEROSOL	Non-intense	1	2022-09-30
3	TOB08	PT	ENDS02a	PUFFMASTER3K	3	Batch 101		75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	34.7	ng/puff	34.7	34.7	ng/puff	AEROSOL	Non-intense	1	2022-09-30
4	TOB08	PT	ENDS02a	PUFFMASTER3K	4	Batch 101				Benzoic Acid	HPHC TESTING	Other	43.3	µg/puff	43.3	43.3	µg/puff	AEROSOL	Non-intense	1	2022-09-30
5	TOB08	PT	ENDS02a	PUFFMASTER3K	5	Batch 101		1954-11-05	NIC	Nicotine	HPHC TESTING	HPHC	105	µg/puff	105	105	µg/puff	AEROSOL	Intense	2	2022-09-30
6	TOB08	PT	ENDS02a	PUFFMASTER3K	6	Batch 101		75-07-0	ACETALD	Acetaldehyde	HPHC TESTING	HPHC	43.5	ng/puff	43.5	43.5	ng/puff	AEROSOL	Intense	2	2022-09-30
7	TOB08	PT	ENDS02a	PUFFMASTER3K	7	Batch 101				Benzoic Acid	HPHC TESTING	Other	84.1	µg/puff	84.1	84.1	µg/puff	AEROSOL	Intense	2	2022-09-30

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 = "Non-intense Regimen".

du.xpt

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	Non-intense Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	Non-intense Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	Non-intense Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	Non-intense Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	Non-intense Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	Non-intense Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	Non-intense Regimen		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	Non-intense Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	Non-intense Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	TOB07	DU	PUFFMASTER3K	1	Intense Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	TOB07	DU	PUFFMASTER3K	2	Intense Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
12	TOB07	DU	PUFFMASTER3K	3	Intense Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
13	TOB07	DU	PUFFMASTER3K	4	Intense Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
14	TOB07	DU	PUFFMASTER3K	5	Intense Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
15	TOB07	DU	PUFFMASTER3K	6	Intense Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
16	TOB07	DU	PUFFMASTER3K	7	Intense Regimen		PUFFRNG	Puff Range	100-200		100-200
17	TOB07	DU	PUFFMASTER3K	8	Intense Regimen	1	PUFFPAUS	Puff Pause	10	s	10	10	s
18	TOB07	DU	PUFFMASTER3K	9	Intense Regimen	1	PUFFPINT	Puff Pause Interval	20	PUFF	20	20	PUFF

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SDTM Example.Product HPHC ENDS Testing