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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 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 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. |
Shelf life study has a protocol and provides the results of shelf life studies of tobacco 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 tobacco products for one testing condition at one timepoint and one replicate.
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construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because their 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. |
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- 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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Row 1: | TTTEST Product Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in TTTSTCND which is STOCONID (i.e., Condition 1 (X°C/ Z% RH Product is sometimes referred to as "Oven Volatiles"Content is used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Moisture Content (see row 3). | Rows 4, 6, 8: | Shows Show the NNK , and NNN , and TSN tests with the results from the tobacco product "as-is" using the TTSPCCND to show that the tobacco is "FRESH"as tested. | Rows 5, 7, 9: | Shows Show the NNK , NNN, and TSN tests with the tobacco product as "Dry and NNN test results as dry weight basis (DWB)" using the TTSPCCND to show that the tobacco is "DRIED".. Note the use of PTTSTDTL = "DRY WEIGHT BASIS" | Rows 2-123, 8-9: | used (pH, water activity, NNK, NNN, TSNA, etc) using the TTTEST and TTTESTCD variables. | |
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TTSEQ | TTREFID | TTTESTCD | TTTEST | TTTSTCND | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU | TTSPEC | TTSPCCND | TTMETHOD | TTLLOQ | TTREPNUM | TTTPT | TTTPTNUM | SPTOBID | STOCONID | PTSEQ | PTTESTCD | PTTEST | PTTSTDTL | PTCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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1 | TOB07 | TTTOB77777.PRODMSTProduct Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 1 | Moisture Content |
| STABILITY TESTING | 52.0 | % | 0.1 | 52.0 | 52.0 | % | | TPT LABCO | TOBACCO | 0.12 | 1 | 02-01-2023 | Week 0 | 1 | 2 | TOB07 | TT2TOB77777. |
| STABILITY TESTING | 8.06 |
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| 8.06 | 8.06 |
| TL009_V1 | TPT LABCO | Condition 1 (X°C/ Z% RH) | TOBACCO |
| 1 | 02-01-2023 | Week 0 | 1 | 3 | TOB07 | TT3TOB77777.Condition 1 | 3 | H2OACT | Water Activity |
Condition 1 (X°C/ Z% RH) | TOBACCO | |
| STABILITY TESTING | 0.86 |
| 0.01 | 0.86 | 0.86 |
| TLPH01_V1 | TPT LABCO | TOBACCO | 0.05 | 1 | 02-01-2023 | 1TT4TOB77777.4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | 1 | Nicotine-Derived Nitrosamine Ketone |
| STABILITY TESTING | 1.0225 | ug/g | 0.01 | 1.0225 | 1.0225 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO | 0.05 | 1 | 02-01-2023 | Week 0 | 1 | 5 | TOB07 | TT5TOB77777.4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | 1 | 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 | 0.05 | 1 | 02-01-2023 | Week 0 | 1 | 6 | TOB07 | TT6TOB77777.nitrosonornicotineCondition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | Nitrosonornicotine |
| STABILITY TESTING | 4.4633 | ug/g | 0.01 | 4.4633 | 4.4633 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO | 0.05 | 1 | 02-01-2023 | 1TT7TOB77777.nitrosonornicotineCondition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | 1 | Week 0 | 1 | 8 | TOB07 | TT | 8 | TOB77777.1 | TSNA | Tobacco-specific nitrosamines | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | Nitrosonornicotine | DRY WEIGHT BASIS | STABILITY TESTING | 2.1424 | ug/g | 0.01 | 2.1424 | 2.1424 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO | 0.05 | 1 | 02-01-2023 | 19TT9TOB77777.TSNA | Tobacco-specific nitrosamines | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | 1 | Week 0 | 1 | AEBCT | Aerobic Colony Count |
| STABILITY TESTING | 154000 | CFU/g | 1 | 154000 | 154000 | CFU/g | TLMB_V1.1 | TPT LABCO | TOBACCO | 1 | 1 | 02-01-2023 |
10 | TOB07 | TT | 10 | TOB77777.1 | AEBPLCT | Aerobic Plate Count | Condition 1 (X°C/ Z% RH) | TOBACCO | 111TT11TOB77777.MOLDMold | Condition 1 (X°C/ Z% RH) | TOBACCO | 1 | Week 0 | 1 | YSTMLDCT | 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 |
12 | TOB07 | TT | 12 | TOB77777.1 | YEAST | Yeast | Condition 1 (X°C/ Z% RH) | TOBACCO | 1 |
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*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
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The second PT dataset shows testing for just 1 parameter (Moisture 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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- Details of the storage conditions are represented in the ES dataset example that follows.
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Rows 1-9: | TTTEST Product Moisture for Condition 1 (X°C/ Z% RH) which is shown in TTTSTCND. The sample of various timepoints that may be used in the testing for product moisture is reflected in TTTPT. The TTTPTNUM 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.testing 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 TTTEST results of Product Moisture for Condition 2 Condition 2 (A °C/ B %RH) across the same timepoints shown for Condition 1. The TTGRPID is used to tie together a block of related records in a single domain.testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID). |
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Row | STUDYID | DOMAIN | TTSEQ | TTREFID | TTTESTCD | TTTEST | TTTSTCND | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU | TTSPEC | TTSPCCND | TTMETHOD | TTREPNUM | TTTPT | | SPTOBID | STOCONID | PTSEQ | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTSPCCND | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUMTTTPTNUM |
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1 | TOB07 | TTPT | 111Smokeless01 | TOB77777.Condition 1 | 111 | MOISTCTTPRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 1 | 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 | TTPT | 112Smokeless01 | TOB77777.Condition 1 | 112 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | Content | 51.96 | % | 0.1 | 51.96 | 51.96 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | 02-01-20232 | Week 0 | 1 | 3 | TOB07 | TTPT | 113Smokeless01 | TOB77777.Condition 1 | 113 | MOISTCTTPRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 3 | 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 | TTPT | 114Smokeless01 | TOB77777.Condition 1 | 114 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | Content | 51.75 | % | 0.1 | 51.75 | 51.75 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | 03-29-20231 | Week 8 | 42 | 5 | TOB07 | TTPT | 115Smokeless01 | TOB77777.Condition 1 | 115 | MOISTCTTPRODMST | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 2 | Week 8 | Content | 51.75 | % | 0.1 | 51.75 | 51.75 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | 03-29-2023 | Week 8 | 24 | 6 | TOB07 | TTPT | 116Smokeless01 | TOB77777.Condition 1 | 116 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | Content | 51.67 | % | 0.1 | 51.67 | 51.67 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | 03-29-20233 | Week 8 | 42 | 7 | TOB07 | TTPT | 117Smokeless01 | TOB77777.Condition 1 | 117 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 1 | Week 48 | Content | 52.05 | % | 0.1 | 52.05 | 52.05 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | 07-19-2023 | Week 24 | 39 | 8 | TOB07 | TTPT | 118Smokeless01 | TOB77777.Condition 1 | 118 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 2 | Week 48 | Content | 52.68 | % | 0.1 | 52.68 | 52.68 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | 07-19-2023 | Week 24 | 39 | 9 | TOB07 | TTPT | 119Smokeless01 | TOB77777.Condition 1 | 119 | PRODMSTMOISTCTT | Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | 3 | Week 48 | 9 | 10 | TOB07 | TT | 120 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 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 | MOISTCTT | Moisture Content | 51.93 | % | 0.1 | 51.93 | 51.93 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | 02-01-20231 | Week 0 | 1 | 11 | TOB07 | PT | Smokeless01 | Condition 2TT | 121 | MOISTCTT | Moisture Content | 51.96 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 2 | 51.96 | 51.96 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | 02-01-2023 | Week 0 | 1 | 12 | TOB07TT | PT | Smokeless01 | Condition 2 | 122 | MOISTCTT | Moisture Content | 51.98 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 51.98 | 51.98 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | 02-01-20233 | Week 0 | 1 | 13 | TOB07 | TT | 123 | | PT | Smokeless01 | Condition 2 | 123 | MOISTCTT | Moisture Content | 51.80 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 51.80 | 51.80 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | 03-29-20231 | Week 8 | 42 | 14 | TOB07 | PT | Smokeless01 | Condition 2TT | 124 | MOISTCTT | Moisture Content | 51.77 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 2 | Week 8 | 51.77 | 51.77 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | 03-29-2023 | Week 8 | 24 | 15 | TOB07TT | PT | Smokeless01 | Condition 2 | 125 | MOISTCTT | Moisture Content | 51.84 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 51.84 | 51.84 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | 03-29-20233 | Week 8 | 42 | 16 | TOB07TT | PT | Smokeless01 | Condition 2 | 126 | MOISTCTT | Moisture Content | 52.18 | % | 0TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 1 | Week 48 | 9 | 17 | TOB07 | TT | 127 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 2 | Week 48 | 9 | 18 | TOB07 | TT | 128 | TOB77777.1 | PRODMST | Product Moisture | Condition 2 (A °C/ B %RH) | % | % | TOBACCO | 3 | Week 48 | 952.18 | 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 | MOISTCTT | 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 | MOISTCTT | 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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Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The ES dataset shows both sets of storage conditions used across both of the PT dataset examples.
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Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
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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 | 85 | % | 4 | TOB07 | ES | Condition 2 | 2 | TEMP | Temperature | 27 | C |
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