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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 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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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.
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| Row 1: | LBTEST Product Moisture Content, which reflects the percentage of moisture in the substance for the condition noted in STOCONID (i.e., Condition 1). 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: | Show the NNK and NNN tests with the results from the tobacco product as tested. | | Rows 5, 7: | Show the NNK and NNN test results as dry weight basis (DWB). Note the use of PTTSTDTL = "DRY WEIGHT BASIS" | | Rows 2-3, 8-9Rows 2-12: | used | |
| Dataset2 |
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| LBSEQ | LBREFID | LBSPID | LBTESTCD | LBTEST | LBTSTCND | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBMETHOD | LBANMETH | LBTMTHSN | LBSTNRC | LBREPNUM | LBTPT | LBTPTNUM | 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 |
LB| PT | Smokeless01 | Condition 1 | 1 |
Product Moisture | Condition 1 (X°C/ Z% RH) | % | % | 1 | | MOISTCTT | Moisture Content |
| STABILITY TESTING | 52.0 | % | 0.1 | 52.0 | 52.0 | % | | TPT LABCO | TOBACCO | 0.12 | 1 | 02-01-2023 | Week 0 |
Week 1TOB08 | | TOB07 | PT | Smokeless01 | Condition 1 |
LBCondition 1 (X°C/ Z% RH) | 1 | |
| STABILITY TESTING | 8.06 |
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| 8.06 | 8.06 |
| TL009_V1 | TPT LABCO | TOBACCO |
| 1 | 02-01-2023 | Week 0 |
Week 1TOB09 | LBCondition 1 (X°C/ Z% RH) | 1 | |
| STABILITY TESTING | 0.86 |
| 0.01 | 0.86 | 0.86 |
| TLPH01_V1 | TPT LABCO | TOBACCO | 0.05 | 1 | 02-01-2023 | Week 0 |
Week 1TOB10 | | TOB07 | PT | Smokeless01 | Condition 1 |
LB-as isCondition 1 (X°C/ Z% RH) | ng/g | ng/g | 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 |
Week 1TOB11 | | TOB07 | PT | Smokeless01 | Condition 1 |
LB-DWB*Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 6 | TOB12 | LB | 6 | NNN-as is | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 7 | TOB13 | LB | 7 | NNK-DWB | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 8 | TOB14 | LB | 8 | TSNA -as is | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 9 | TOB15 | LB | 9 | TSNA -DWB | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 10 | TOB16 | LB | 10 | Aerobic Plate Count | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | 11 | TOB17 | LB | 11 | Mold | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | 12 | TOB18 | LB | 12 | Yeast | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | |
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*DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.
Make sure LOQ is in the dataset - it is important.
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| 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 | 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 | TOBACCO | 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 | 0.05 | 1 | 02-01-2023 | Week 0 | 1 | | 8 | TOB07 | PT | Smokeless01 | Condition 1 | 8 | 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 | Week 0 | 1 | | 9 | TOB07 | PT | Smokeless01 | Condition 1 | 9 | 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 | Week 0 | 1 |
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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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| Row Rows 1-9: | Shows LBTEST Product Moisture which reflects the percentage of moisture in the substance for the condition noted in LBTSTCND which is Condition 1 (X°C/ Z% RH). Product Moisture is sometimes referred to as "Oven Volatiles".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 results of testing Moisture Content in 3 replicates (PTREPNUM) at 3 timepoints (weeks 0, 8, and 24) under the storage "Condition 2" (STOCONID). | Rows 2-12: | Show the analytes used in testing. |
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| Row | STUDYID | DOMAIN | SPTOBID | STOCONID |
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LBSEQLBREFIDLBSPIDLBTESTCDLBTESTLBTSTCNDLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBMETHODLBANMETHLBTMTHSNLBSTNRCLBREPNUMLBTPTLBTPTNUMLB| PT | Smokeless01 | Condition 1 | 111 | MOISTCTT |
Product Condition 1 (X°C/ Z% RH) | % | % | 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 |
Week 1TOB08LB2pH | Condition 1 (X°C/ Z% RH) | 1 | | Condition 1 | 112 | MOISTCTT | 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 |
Week 1TOB09| TOB07 | PT | Smokeless01 | Condition 1 | 113 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | MOISTCTT | 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 | 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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| Dataset2 |
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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 |
LB | 3 | Water Activity | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | 4 | TOB10 | LB | 4 | NNK-as is | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 5 | TOB11 | LB | 5 | NNK-DWB* | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 6 | TOB12 | LB | 6 | NNN-as is | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 7 | TOB13 | LB | 7 | NNK-DWB | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 8 | TOB14 | LB | 8 | TSNA -as is | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 9 | TOB15 | LB | 9 | TSNA -DWB | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | 1 | Week 1 | 1 | 10 | TOB16 | LB | 10 | Aerobic Plate Count | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | 11 | TOB17 | LB | 11 | Mold | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 | 12 | TOB18 | LB | 12 | Yeast | Condition 1 (X°C/ Z% RH) | 1 | Week 1 | 1 |
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