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.

Question: For laboratory's limit of detection (LOD), limit of quantification (LOQ); Should we have --ORNRLO = Reference Range Lower Limit in Orig Unit; and --ORNRHI = Reference Range Upper Limit in Orig Unit? There is a variable --LLOD = Lower Limit of Detection. Added this for LOD. What should be used for LOQ? Thanks.

Rows 1-20:	Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is Condition 1.
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 PTSCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is Condition 1.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	STOCONDID	PTSEQ	PTREFID	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	Condition 1	1	VAP77777.1	NICOTINE	Nicotine	STABILITY STUDY		35.94	mg/g		35.94	35.94	mg/g	E-LIQUID	1	Week 0	1
2	TOB07	PT	111	Condition 1	2	VAP77777.1	NICOTINE	Nicotine	STABILITY STUDY		0.1039	mg/PUFF		0.1039	0.1039	mg/PUFF	AEROSOL	1	Week 0	1
3	TOB07	PT	111	Condition 1	3	VAP77777.1	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	25.76	ug/g		25.76	25.76	ug/g	E-LIQUID	1	Week 0	1
4	TOB07	PT	111	Condition 1	3	VAP77777.1	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	0.0392	ug/PUFF		0.0392	0.0392	ug/PUFF	AEROSOL	1	Week 0	1
5	TOB07	PT	111	Condition 1	5	VAP77777.1	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	615.68	mg/g		615.68	615.68	mg/g	E-LIQUID	1	Week 0	1
6	TOB07	PT	111	Condition 1	5	VAP77777.1	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	1.81	mg/PUFF	0.00144	1.81	1.81	mg/PUFF	AEROSOL	1	Week 0	1
7	TOB07	PT	111	Condition 1	6	VAP77777.1	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	218.21	mg/g		218.21	218.21	mg/g	E-LIQUID	1	Week 0	1
8	TOB07	PT	111	Condition 1	6	VAP77777.1	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	0.8565	mg/PUFF	0.00024	0.8565	0.8565	mg/PUFF	AEROSOL	1	Week 0	1
9	TOB07	PT	111	Condition 1	7	VAP77777.1	BNZOICAC	Benzoic Acid	STABILITY STUDY	Acid							E-LIQUID	1	Week 0	1
10	TOB07	PT	111	Condition 1	8	VAP77777.1	MENTHOL	Menthol	STABILITY STUDY	Flavorant	37.53	mg/g		37.53	37.53	mg/g	E-LIQUID	1	Week 0	1
11	TOB07	PT	111	Condition 1	8	VAP77777.1	MENTHOL	Menthol	STABILITY STUDY	Flavorant	0.5881	mg/PUFF	0.00024	0.5881	0.5881	mg/PUFF	AEROSOL	1	Week 0	1
12	TOB07	PT	111	Condition 1		VAP77777.1	GLYCDOL	Glycidol	STABILITY STUDY	Stabilizer	<Limit of Detection (LOD)		0.00011	<Limit of detection (LOD)			AEROSOL	1	Week 0	1
13	TOB07	PT	111	Condition 1		VAP77777.1	FRMLDHD	Formaldehyde	STABILITY STUDY		0.0728	ug/PUFF	0.00549	0.0728	0.0728	ug/PUFF	AEROSOL	1	Week 0	1
14	TOB07	PT	111	Condition 1		VAP77777.1	ACROLN	Acrolien	STABILITY STUDY		<Limit of Quantification (LOQ)		0.00928	Limit of Quantification (LOQ)			AEROSOL	1	Week 0	1
15	TOB07	PT	111	Condition 1		VAP77777.1	LACTICAC	Lactic Acid	STABILITY STUDY		40.44	ug/g		40.44	40.44	ug/g	E-LIQUID	1	Week 0	1
16	TOB07	PT	111	Condition 1		VAP77777.1	LACTICAC	Lactic Acid	STABILITY STUDY		29.71	ug/PUFF	0.284	29.71	29.71	ug/PUFF	AEROSOL	1	Week 0	1
17	TOB07	PT	111	Condition 1	9	VAP77777.1	VANLLN	Vanillin	STABILITY STUDY	Flavorant	1.12	ug/g		1.12	1.12	ug/g	E-LIQUID	1	Week 0	1
18	TOB07	PT	111	Condition 1	10	VAP77777.1	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0711	ug/g		0.0711	0.0711	ug/g	E-LIQUID	1	Week 0	1
19	TOB07	PT	111	Condition 1	11	VAP77777.1	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0852	ug/g		0.0852	0.0852	ug/g	E-LIQUID	1	Week 0	1
20	TOB07	PT	111	Condition 1	12	VAP77777.1	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0577	ug/PUFF		0.0577	0.0577	ug/PUFF	AEROSOL	1	Week 0	1
21	TOB07	PT	111	Condition 1	13	VAP77777.1	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0742	ug/PUFF		0.0742	0.0742	ug/PUFF	AEROSOL	1	Week 0	1
22	TOB07	PT	111	Condition 1	14	VAP77777.1	NICKEL	Nickel	STABILITY STUDY	Extractables / Leachables	0.0897	ug/g		0.0897	0.0897	ug/g	E-LIQUID	1	Week 0	1
23	TOB07	PT	111	Condition 1	14	VAP77777.1	MASS	Mass	STABILITY STUDY		3.87	mg/PUFF	0.0071	3.87	3.87	mg/PUFF	AEROSOL	1	Week 0	1
24	TOB07	PT	111	Condition 1	14	VAP77777.1	CHROMIUM	Chromium	STABILITY STUDY		NOT DETECTED			NOT DETECTED			E-LIQUID	1	Week 0	1
25	TOB07	PT	111	Condition 1	15	VAP77777.1	PH	pH	STABILITY STUDY		7.15			7.15	7.15		E-LIQUID	1	Week 0	1
26	TOB07	PT	111	Condition 1	15	VAP77777.1	PH	pH	STABILITY STUDY		7.24			7.24	7.24		AEROSOL	1	Week 0	1
27	TOB07	PT	111	Condition 1	16	VAP77777.1	ENDTXN	Endotoxin	STABILITY STUDY	Toxins							E-LIQUID	1	Week 0	1
28	TOB07	PT	111	Condition 1	17	VAP77777.1	AEBPLCT	Aerobic Plate Count	STABILITY STUDY	Microbiological	<1	CFU/mL		<1	<1	CFU/mL	E-LIQUID	1	Week 0	1
29	TOB07	PT	111	Condition 1	18	VAP77777.1	TYMC	Total Yeast and/or Mold Count	STABILITY STUDY	Microbiological	1	CFU/mL		1	1	CFU/mL	E-LIQUID	1	Week 0	1
30	TOB07	PT	111	Condition 1	19	VAP77777.1	ACTALD	Acetaldehyde	STABILITY STUDY	Aldehyde							E-LIQUID	1	Week 0	1
31	TOB07	PT	111	Condition 1	20	VAP77777.1	ACTPROPN	Acetyl Propionyl	STABILITY STUDY	Diketone							E-LIQUID	1	Week 0	1

Dataset Debug Messages

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Dataset Wrapper Debug Message

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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 Condition 1 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 Condition 2 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 Condition 3 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	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	Condition 1	211	VAP77777.1	1	NICOTINE	Nicotine	35.94	mg/g	35.94	35.94	mg/g	E-LIQUID	1	Week 0	1
2	TOB07	PT	111	Condition 1	212	VAP77777.1	1	NICOTINE	Nicotine	35.46	mg/g	35.46	35.46	mg/g	E-LIQUID	2	Week 0	1
3	TOB07	PT	111	Condition 1	213	VAP77777.1	1	NICOTINE	Nicotine	35.97	mg/g	35.97	35.97	mg/g	E-LIQUID	3	Week 0	1
4	TOB07	PT	111	Condition 1	214	VAP77777.1	1	NICOTINE	Nicotine	35.55	mg/g	35.55	35.55	mg/g	E-LIQUID	1	Week 24	4
5	TOB07	PT	111	Condition 1	215	VAP77777.1	1	NICOTINE	Nicotine	35.88	mg/g	35.88	35.88	mg/g	E-LIQUID	2	Week 24	4
6	TOB07	PT	111	Condition 1	216	VAP77777.1	1	NICOTINE	Nicotine	35.67	mg/g	35.67	35.67	mg/g	E-LIQUID	3	Week 24	4
7	TOB07	PT	111	Condition 1	217	VAP77777.1	1	NICOTINE	Nicotine	36.11	mg/g	36.11	36.11	mg/g	E-LIQUID	1	Week 52	9
8	TOB07	PT	111	Condition 1	218	VAP77777.1	1	NICOTINE	Nicotine	35.72	mg/g	35.72	35.72	mg/g	E-LIQUID	2	Week 52	9
9	TOB07	PT	111	Condition 1	219	VAP77777.1	1	NICOTINE	Nicotine	35.54	mg/g	35.54	35.54	mg/g	E-LIQUID	3	Week 52	9
10	TOB07	PT	111	Condition 2	220	VAP77777.1	3	NICOTINE	Nicotine	0.1039	mg/PUFF	0.1039	0.1039	mg/puff	AEROSOL	1	Week 0	1
11	TOB07	PT	111	Condition 2	221	VAP77777.1	3	NICOTINE	Nicotine	0.1142	mg/PUFF	0.1142	0.1142	mg/puff	AEROSOL	2	Week 0	1
12	TOB07	PT	111	Condition 2	222	VAP77777.1	3	NICOTINE	Nicotine	0.1282	mg/PUFF	0.1282	0.1282	mg/puff	AEROSOL	3	Week 0	1
13	TOB07	PT	111	Condition 2	223	VAP77777.1	3	NICOTINE	Nicotine	0.1242	mg/PUFF	0.1242	0.1242	mg/puff	AEROSOL	1	Week 24	4
14	TOB07	PT	111	Condition 2	224	VAP77777.1	3	NICOTINE	Nicotine	0.1084	mg/PUFF	0.1084	0.1084	mg/puff	AEROSOL	2	Week 24	4
15	TOB07	PT	111	Condition 2	225	VAP77777.1	3	NICOTINE	Nicotine	0.1174	mg/PUFF	0.1174	0.1174	mg/puff	AEROSOL	3	Week 24	4
16	TOB07	PT	111	Condition 2	226	VAP77777.1	3	NICOTINE	Nicotine	0.1374	mg/PUFF	0.1374	0.1374	mg/puff	AEROSOL	1	Week 52	9
17	TOB07	PT	111	Condition 2	227	VAP77777.1	3	NICOTINE	Nicotine	0.1364	mg/PUFF	0.1364	0.1364	mg/puff	AEROSOL	2	Week 52	9
18	TOB07	PT	111	Condition 2	228	VAP77777.1	3	NICOTINE	Nicotine	0.1264	mg/PUFF	0.1264	0.1264	mg/puff	AEROSOL	3	Week 52	9
19	TOB07	PT	111	Condition 2	229	VAP77777.1	3	NICOTINE	Nicotine	0.1256	mg/PUFF	0.1256	0.1256	mg/puff	AEROSOL	1	Week 0	1
20	TOB07	PT	111	Condition 3	230	VAP77777.1	4	NICOTINE	Nicotine	0.1236	mg/PUFF	0.1236	0.1236	mg/puff	AEROSOL	2	Week 0	1
21	TOB07	PT	111	Condition 3	231	VAP77777.1	4	NICOTINE	Nicotine	0.1126	mg/PUFF	0.1126	0.1126	mg/puff	AEROSOL	3	Week 0	1
22	TOB07	PT	111	Condition 3	232	VAP77777.1	4	NICOTINE	Nicotine	0.1334	mg/PUFF	0.1334	0.1334	mg/puff	AEROSOL	1	Week 24	4
23	TOB07	PT	111	Condition 3	233	VAP77777.1	4	NICOTINE	Nicotine	0.1134	mg/PUFF	0.1134	0.1134	mg/puff	AEROSOL	2	Week 24	4
24	TOB07	PT	111	Condition 3	234	VAP77777.1	4	NICOTINE	Nicotine	0.1125	mg/PUFF	0.1125	0.1125	mg/puff	AEROSOL	3	Week 24	4
25	TOB07	PT	111	Condition 3	235	VAP77777.1	4	NICOTINE	Nicotine	0.1156	mg/PUFF	0.1156	0.1156	mg/puff	AEROSOL	1	Week 52	9
26	TOB07	PT	111	Condition 3	236	VAP77777.1	4	NICOTINE	Nicotine	0.1145	mg/PUFF	0.1145	0.1145	mg/puff	AEROSOL	2	Week 52	9
27	TOB07	PT	111	Condition 3	237	VAP77777.1	4	NICOTINE	Nicotine	0.1157	mg/PUFF	0.1157	0.1157	mg/puff	AEROSOL	3	Week 52	9

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.

es.xpt

Row	STUDYID	DOMAIN	STOCONID	ESSEQ	ESPARMCD	ESPARM	ESVAL	ESVALU
1	TOB07	ES	Condition 1	1	HUMID	Humidity	37	%
2	TOB07	ES	Condition 1	2	TEMP	Temperature	24	C
3	TOB07	ES	Condition 2	1	HUMID	Humidity	60	%
4	TOB07	ES	Condition 2	2	TEMP	Temperature	27	C
5	TOB07	ES	Condition 3	1	HUMID	Humidity	95	%
6	TOB07	ES	Condition 3	2	TEMP	Temperature	31	C

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SDTM Example.Stability Study for E-Liquid Products