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Info

The first PT dataset shows 7 constituents/parameters, each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because they are tested separately in both tobacco "as-is" and dried tobacco (as indicated by PTSPEC and PTSPCCNDtheir results are reported two separate ways: once for the result as tested and once where the result is expressed as dry weight basis (the latter is indicated by PTTSTDTL = DRY WEIGHT BASIS). Note that the constituent/parameter names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

Note

STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the 2 PT dataset examples.
PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent/parameter when such methodology is too complex for the single PTMETHOD variable.

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Name	pt

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Row 1:	Shows the PTTEST of product moistureMoisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1). Product moisture Moisture Content is used in chemistry stability studies. For microbial stability studies, water activity Water Activity should be used, not product moisture Moisture Content (see row 3).
Rows 4, 6, 8:	Show the NNK , and NNN , and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH"results from the tobacco product as tested.
Rows 5, 7, 9:	Show the NNK , NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" and NNN test results as dry weight basis (DWB) using the PTSPCCND to show that the tobacco is "DRIED".. Note the use of PTTSTDTL = "DRY WEIGHT BASIS"
Rows 2-3, 8-119:	Show the other analytes used measured in testing (i.e., pH, water activity, NNK, NNN, TSNA) using the PTTEST and PTTESTCD variables.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTTESTCD	PTTEST	PTTSTDTL	PTCAT	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTXFN	PTNAM	PTSPEC	PTSPCCND	PTLLOQ	PTREPNUM	PTDTC	PTTPT	PTTPTNUM
1	TOB07	PT	Smokeless01	Condition 1	1	PRODMSTMOISTCTT	Product Moisture Content		STABILITY TESTING	52.0	%	0.1	52.0	52.0	%	TLT07_V1	TPT LABCO	TOBACCO	0.12	1	02-01-2023	Week 0	1
2	TOB07	PT	Smokeless01	Condition 1	2	PH	pH		STABILITY TESTING	8.06			8.06	8.06		TL009_V1	TPT LABCO	TOBACCO		1	02-01-2023	Week 0	1
3	TOB07	PT	Smokeless01	Condition 1	3	H2OACT	Water Activity		STABILITY TESTING	0.86		0.01	0.86	0.86		TLPH01_V1	TPT LABCO	TOBACCO	0.05	1	02-01-2023	Week 0	1
4	TOB07	PT	Smokeless01	Condition 1	4	NNK	Nicotine-Derived Nitrosamine Ketone		STABILITY TESTING	1.0225	ug/g	0.01	1.0225	1.0225	ug/g	TL026_V12.2	TPT LABCO	TOBACCOAS-IS	0.05	1	02-01-2023	Week 0	1
5	TOB07	PT	Smokeless01	Condition 1	5	NNK	Nicotine-Derived Nitrosamine Ketone	DRY WEIGHT BASIS	STABILITY TESTING	0.4908	ug/g	0.01	0.4908	0.4908	ug/g	TL026_V12.2	TPT LABCO	TOBACCO	DRIED	0.05	1	02-01-2023	Week 0	1
6	TOB07	PT	Smokeless01	Condition 1	6	NNN	N-Nitrosonornicotine		STABILITY TESTING	4.4633	ug/g	0.01	4.4633	4.4633	ug/g	TL026_V12.2	TPT LABCO	TOBACCOAS-IS	0.05	1	02-01-2023	Week 0	1
7	TOB07	PT	Smokeless01	Condition 1	7	NNN	N-Nitrosonornicotine	DRY WEIGHT BASIS	STABILITY TESTING	2.1424	ug/g	0.01	2.1424	2.1424	ug/g	TL026_V12.2	TPT LABCO	TOBACCO	DRIED	0.05	1	02-01-2023	Week 0	1
108	TOB07	PT	Smokeless01	Condition 1	8	AEBPLCTAEBCT	Aerobic Plate Colony Count		STABILITY TESTING	154000	CFU/g	1	154000	154000	CFU/g	TLMB_V1.1	TPT LABCO	TOBACCO	1	1	02-01-2023	Week 0	1
119	TOB07	PT	Smokeless01	Condition 1	9	TYMCYSTMLDCT	Total Yeast and/or Mold Colony Count		STABILITY TESTING	<10	CFU/g	1	<10		CFU/g	TLMB_V1.1	TPT LABCO	TOBACCO	1	1	02-01-2023	Week 0	1

Info

The second PT dataset shows testing for just 1 parameter (product moistureMoisture Content), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 2 sets of storage conditions (STOCONID), in samples of both dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study.

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Name	pt

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Rows 1-9:	Show the results of testing product moisture Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 1" (STOCONID).
Rows 10-18:	Show the results of testing product moisture Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID).

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTTESTCD	PTTEST	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTXFN	PTNAM	PTSPEC	PTSPCCND	PTLLOQ	PTREPNUM	PTDTC	PTTPT	PTTPTNUM
1	TOB07	PT	Smokeless01	Condition 1	111	PRODMSTMOISTCTT	Product Moisture Content	51.93	%	0.1	51.93	51.93	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	02-01-2023	Week 0	1
2	TOB07	PT	Smokeless01	Condition 1	112	PRODMSTMOISTCTT	Product Moisture Content	51.96	%	0.1	51.96	51.96	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	02-01-2023	Week 0	1
3	TOB07	PT	Smokeless01	Condition 1	113	PRODMSTMOISTCTT	Product Moisture Content	51.98	%	0.1	51.98	51.98	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	02-01-2023	Week 0	1
4	TOB07	PT	Smokeless01	Condition 1	114	PRODMSTMOISTCTT	Product Moisture Content	51.75	%	0.1	51.75	51.75	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	03-29-2023	Week 8	2
5	TOB07	PT	Smokeless01	Condition 1	115	PRODMSTMOISTCTT	Product Moisture Content	51.75	%	0.1	51.75	51.75	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	03-29-2023	Week 8	2
6	TOB07	PT	Smokeless01	Condition 1	116	PRODMSTMOISTCTT	Product Moisture Content	51.67	%	0.1	51.67	51.67	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	03-29-2023	Week 8	2
7	TOB07	PT	Smokeless01	Condition 1	117	PRODMSTMOISTCTT	Product Moisture Content	52.05	%	0.1	52.05	52.05	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	07-19-2023	Week 24	3
8	TOB07	PT	Smokeless01	Condition 1	118	PRODMSTMOISTCTT	Product Moisture Content	52.68	%	0.1	52.68	52.68	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	07-19-2023	Week 24	3
9	TOB07	PT	Smokeless01	Condition 1	119	PRODMSTMOISTCTT	Product Moisture Content	52.21	%	0.1	52.21	52.21	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	07-19-2023	Week 24	3
10	TOB07	PT	Smokeless01	Condition 2	120	PRODMSTMOISTCTT	Product Moisture Content	51.93	%	0.1	51.93	51.93	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	02-01-2023	Week 0	1
11	TOB07	PT	Smokeless01	Condition 2	121	PRODMSTMOISTCTT	Product Moisture Content	51.96	%	0.1	51.96	51.96	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	02-01-2023	Week 0	1
12	TOB07	PT	Smokeless01	Condition 2	122	PRODMSTMOISTCTT	Product Moisture Content	51.98	%	0.1	51.98	51.98	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	02-01-2023	Week 0	1
13	TOB07	PT	Smokeless01	Condition 2	123	PRODMSTMOISTCTT	Product Moisture Content	51.80	%	0.1	51.80	51.80	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	03-29-2023	Week 8	2
14	TOB07	PT	Smokeless01	Condition 2	124	PRODMSTMOISTCTT	Product Moisture Content	51.77	%	0.1	51.77	51.77	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	03-29-2023	Week 8	2
15	TOB07	PT	Smokeless01	Condition 2	125	PRODMSTMOISTCTT	Product Moisture Content	51.84	%	0.1	51.84	51.84	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	03-29-2023	Week 8	2
16	TOB07	PT	Smokeless01	Condition 2	126	PRODMSTMOISTCTT	Product Moisture Content	52.18	%	0.1	52.18	52.18	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	07-19-2023	Week 24	3
17	TOB07	PT	Smokeless01	Condition 2	127	PRODMSTMOISTCTT	Product Moisture Content	52.21	%	0.1	52.21	52.21	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	07-19-2023	Week 24	3
18	TOB07	PT	Smokeless01	Condition 2	128	PRODMSTMOISTCTT	Product Moisture Content	51.87	%	0.1	51.87	51.87	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	07-19-2023	Week 24	3

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