SDTM Example.Stability Study for E-Liquid Products

THIS EXAMPLE IS UNDER RE-CONSTRUCTION FOLLOWING THE TEAM CALL ON 17 JAN. See also example in the "sandbox' here, which demonstrates the current approach reviewed on that call.

NOTE TO TEAM REVIEWERS:

The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study.
The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study.

For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows:

First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated.

Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like.

Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group.

The example shown below is not an all inclusive comprehensive example. It is meant to be illustrative of the concepts.

Shelf life study has a protocol and provides the results of shelf life studies of Vapes products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc. The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for Vapes products for one testing condition at one timepoint and one replicate.

Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.

PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.

Rows 1-20:	Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition.
Rows 2, 12, 13:	Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable.
Rows 17, 18:	Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is E-Liquid Standard (Long Term) Condition.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	STOCONDID	PTSEQ	PTREFID	PTCAS	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	1	VAP77777.1	54-11-5	NIC	Nicotine	STABILITY STUDY		E-LIQUID	1	Week 0	1
2	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	2	VAP77777.1	54-11-5	NIC	Nicotine	STABILITY STUDY		AEROSOL	1	Week 0	1
3	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	3	VAP77777.1	494-97-3	XXXXX	Nornicotine	STABILITY STUDY	Nicotine Degradant	E-LIQUID	1	Week 0	1
4	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	4	VAP77777.1	494-52-0	XXXXX	Anabasine	STABILITY STUDY	Nicotine Degradant	E-LIQUID	1	Week 0	1
5	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	5	VAP77777.1	56-81-5	XXXXX	Glycerin	STABILITY STUDY	Primary Ingredient	E-LIQUID	1	Week 0	1
6	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	6	VAP77777.1	57-55-6	XXXXX	Propylene Glycol	STABILITY STUDY	Primary Ingredient	E-LIQUID	1	Week 0	1
7	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	7	VAP77777.1	65-85-0	XXXXX	Benzoic Acid	STABILITY STUDY	Acid	E-LIQUID	1	Week 0	1
8	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	8	VAP77777.1	89-78-1 confirm this one, there are two - the other is 1490-04-6	XXXXX	Menthol	STABILITY STUDY	Flavorant	E-LIQUID	1	Week 0	1
9	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	9	VAP77777.1		XXXXX	Vanillin	STABILITY STUDY	Flavorant	E-LIQUID	1	Week 0	1
10	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	10	VAP77777.1	64091-91-4	NNK	4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)	STABILITY STUDY	HPHC	E-LIQUID	1	Week 0	1
11	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	11	VAP77777.1	80508-23-2	NNN	N-nitrosonornicotine	STABILITY STUDY	HPHC	E-LIQUID	1	Week 0	1
12	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	12	VAP77777.1	64091-91-4	NNK	4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK)	STABILITY STUDY	HPHC	AEROSOL	1	Week 0	1
13	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	13	VAP77777.1	80508-23-2	NNN	N-nitrosonornicotine	STABILITY STUDY	HPHC	AEROSOL	1	Week 0	1
14	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	14	VAP77777.1		XXXXX	Metals - Nickel	STABILITY STUDY	Extractables / Leachables	E-LIQUID	1	Week 0	1
15	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	15	VAP77777.1		PH	pH	STABILITY STUDY		E-LIQUID	1	Week 0	1
16	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	16	VAP77777.1		XXXXX	Endotoxin	STABILITY STUDY	Toxins	E-LIQUID	1	Week 0	1
17	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	17	VAP77777.1		XXXXX	TAMC	STABILITY STUDY	Microbiological	E-LIQUID	1	Week 0	1
18	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	18	VAP77777.1		XXXXX	TYMC	STABILITY STUDY	Microbiological	E-LIQUID	1	Week 0	1
19	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	19	VAP77777.1	75-07-0	XXXXX	Acetaldehyde	STABILITY STUDY	Aldehyde	E-LIQUID	1	Week 0	1
20	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	20	VAP77777.1		XXXXX	Acetyl propionyl	STABILITY STUDY	Diketone	E-LIQUID	1	Week 0	1

Dataset Debug Messages

There is a leading, trailing, or non-breaking space in the dataset.
Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.

Rows 1-9:	Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-19:	Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:	Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTREFID	PTGRPID	PTTESTCD	PTTEST	PTORRESU	PTSTRESU	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	211	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 0	1
2	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	212	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 0	1
3	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	213	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 0	1
4	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	214	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 24	4
5	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	215	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 24	4
6	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	216	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 24	4
7	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	217	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 52	9
8	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	218	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 52	9
9	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	219	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 52	9
10	TOB07	PT	111	E-Vapor Standard Aerosol Condition	220	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 0	1
11	TOB07	PT	111	E-Vapor Standard Aerosol Condition	221	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 0	1
12	TOB07	PT	111	E-Vapor Standard Aerosol Condition	222	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 0	1
13	TOB07	PT	111	E-Vapor Standard Aerosol Condition	223	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 24	4
14	TOB07	PT	111	E-Vapor Standard Aerosol Condition	224	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 24	4
15	TOB07	PT	111	E-Vapor Standard Aerosol Condition	225	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 24	4
16	TOB07	PT	111	E-Vapor Standard Aerosol Condition	226	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 52	9
17	TOB07	PT	111	E-Vapor Standard Aerosol Condition	227	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 52	9
18	TOB07	PT	111	E-Vapor Standard Aerosol Condition	228	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 52	9
19	TOB07	PT	111	E-Vapor Standard Aerosol Condition	229	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 0	1
20	TOB07	PT	111	E-Vapor Intense Aerosol Condition	230	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 0	1
21	TOB07	PT		E-Vapor Intense Aerosol Condition	231	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 0	1
22	TOB07	PT		E-Vapor Intense Aerosol Condition	232	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 24	4
23	TOB07	PT		E-Vapor Intense Aerosol Condition	233	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 24	4
24	TOB07	PT		E-Vapor Intense Aerosol Condition	234	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 24	4
25	TOB07	PT		E-Vapor Intense Aerosol Condition	235	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 52	9
26	TOB07	PT		E-Vapor Intense Aerosol Condition	236	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 52	9
27	TOB07	PT		E-Vapor Intense Aerosol Condition	237	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 52	9

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Update the DI and DU. Check on the Aerosol Intense Condition.

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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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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es.xpt

Row	STUDYID	DOMAIN	STOCONID	ESSEQ	ESPARMCD	ESPARM	ESVAL	ESVALU
1	TOB07	ES	E-Liquid Standard (Long Term) Condition	1	HUMID	Humidity	37	%
2	TOB07	ES	E-Liquid Standard (Long Term) Condition	2	TEMP	Temperature	24	C
3	TOB07	ES	E-Vapor Standard Aerosol Condition	1	HUMID	Humidity	85	%
4	TOB07	ES	E-Vapor Standard Aerosol Condition	2	TEMP	Temperature	27	C
5	TOB07	ES	E-Vapor Intense Aerosol Condition	1	HUMID	Humidity	95	%
6	TOB07	ES	E-Vapor Intense Aerosol Condition	2	TEMP	Temperature	31	C

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SDTM Example.Stability Study for E-Liquid Products