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The first pt.xpt dataset shows 7 constituents / parameters, each as a single replicate (PTREPNUM=1), at one time point (PTTPT=Week 0 / PTTPTNUM=1) and from one 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 / PTSPECCND). Note that the constituent 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 two 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 when such methodology is too complex for the single PTMETHOD variable.
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| Row 1: | Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in STOCONID which is Condition 1. Product Moisture is sometimes referred to as "Oven Volatiles". | | Rows 4, 6, 8: | Show the NNK, NNN, and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH". | | Rows 5, 7, 9: | Show the NNK, NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" (DWB) using the PTSPCCND to show that the tobacco is "DRIED". | | Rows 2-11: | Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables. | |
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| Row | STUDYID | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTTESTCD | PTTEST | PTCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTSPCCND | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | Smokeless01 | Condition 1 | 1 | PRODMST | Product Moisture | STABILITY STUDY | 52.0 | % | 0.1 | 52.0 | 52.0 | % | TLT07_V1 | TPT LABCO | TOBACCO |
| 0.12 | 1 | Week 0 | 1 | | 2 | TOB07 | PT | Smokeless01 | Condition 1 | 2 | PH | pH | STABILITY STUDY | 8.06 |
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| 8.06 | 8.06 |
| TL009_V1 | TPT LABCO | TOBACCO |
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| 1 | Week 0 | 1 | | 3 | TOB07 | PT | Smokeless01 | Condition 1 | 3 | H2OACT | Water Activity | STABILITY STUDY | 0.86 |
| 0.01 | 0.86 | 0.86 |
| TLPH01_V1 | TPT LABCO | TOBACCO |
| 0.05 | 1 | Week 0 | 1 | | 4 | TOB07 | PT | Smokeless01 | Condition 1 | 4 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | 1.0225 | ug/g | 0.01 | 1.0225 | 1.0225 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO, FRESH | AS-IS | 0.05 | 1 | Week 0 | 1 | | 5 | TOB07 | PT | Smokeless01 | Condition 1 | 5 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | 0.4908 | ug/g | 0.01 | 0.4908 | 0.4908 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO, DRIED | DRIED | 0.05DRY WEIGHT | 1 | Week 0 | 1 | | 6 | TOB07 | PT | Smokeless01 | Condition 1 | 6 | NNN | N-Nitrosonornicotine | STABILITY STUDY | 4.4633 | ug/g | 0.01 | 4.4633 | 4.4633 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO, FRESH | AS-IS | 0.05 | 1 | Week 0 | 1 | | 7 | TOB07 | PT | Smokeless01 | Condition 1 | 7 | NNN | N-Nitrosonornicotine | STABILITY STUDY | 2.1424 | ug/g | 0.01 | 2.1424 | 2.1424 | ug/g | TL026_V12.2 | TPT LABCO | TOBACCO | , DRIEDDRY | WEIGHT0.05 | 1 | Week 0 | 1 | | 10 | TOB07 | PT | Smokeless01 | Condition 1 | 8 | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | 154000 | CFU/g | 1 | 154000 | 154000 | CFU/g | TLMB_V1.1 | TPT LABCO | TOBACCO |
| 1 | 1 | Week 0 | 1 | | 11 | TOB07 | PT | Smokeless01 | Condition 1 | 9 | TYMC | Total Yeast and/or Mold Count | STABILITY STUDY | <10 | CFU/g | <101 | <10 |
| CFU/g | TLMB_V1.1 | TPT LABCO | TOBACCO |
| 1 | 1 | Week 0 | 1 |
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The second pt.xpt dataset shows testing for just one constituent, nicotine, performed in three replicates (note the values of PTREPNUM), at three time points (as shown in PTTPT / PTTPTNUM), from three sets of storage conditions (STOCONID), in samples of e-liquid and aerosol )PTSPEC) in order to illustrate how those variables are used to represent their associated concepts in a stability study. |
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| Rows 1-93: | Show the PTTEST results of testing Product Moisture for Condition 1 which is shown in STOCONID. The sample of various timepoints that may be used in the testing for product moisture 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.in three replicates (PTREPNUM =1,2,3, respectively) at Week 0, which is the first timepoint in the study (PTTPT, PTTPTNUM) , under the storage conditions indicated in STOCONID. | | Rows 10-18: | Show the PTTEST of Product Moisture for Condition 2 across the same timepoints shown for Condition 1. | |
| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTSPCCND | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | Smokeless01 | Condition 1 | 111 | PRODMST | Product Moisture | 51.93 | % | 0.1 | 51.93 | 51.93 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 0 | 1 | | 2 | TOB07 | PT | Smokeless01 | Condition 1 | 112 | PRODMST | Product Moisture | 51.96 | % | 0.1 | 51.96 | 51.96 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 0 | 1 | | 3 | TOB07 | PT | Smokeless01 | Condition 1 | 113 | PRODMST | Product Moisture | 51.98 | % | 0.1 | 51.98 | 51.98 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 0 | 1 | | 4 | TOB07 | PT | Smokeless01 | Condition 1 | 114 | PRODMST | Product Moisture | 51.75 | % | 0.1 | 51.75 | 51.75 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 8 | 42 | | 5 | TOB07 | PT | Smokeless01 | Condition 1 | 115 | PRODMST | Product Moisture | 51.75 | % | 0.1 | 51.75 | 51.75 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 8 | 42 | | 6 | TOB07 | PT | Smokeless01 | Condition 1 | 116 | PRODMST | Product Moisture | 51.67 | % | 0.1 | 51.67 | 51.67 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 8 | 42 | | 7 | TOB07 | PT | Smokeless01 | Condition 1 | 117 | PRODMST | Product Moisture | 52.05 | % | 0.1 | 52.05 | 52.05 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 4824 | 93 | | 8 | TOB07 | PT | Smokeless01 | Condition 1 | 118 | PRODMST | Product Moisture | 52.68 | % | 0.1 | 52.68 | 52.68 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 4824 | 93 | | 9 | TOB07 | PT | Smokeless01 | Condition 1 | 119 | PRODMST | Product Moisture | 52.21 | % | 0.1 | 52.21 | 52.21 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 4824 | 93 | | 10 | TOB07 | PT | Smokeless01 | Condition 2 | 120 | PRODMST | Product Moisture | 51.93 | % | 0.1 | 51.93 | 51.93 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 0 | 1 | | 11 | TOB07 | PT | Smokeless01 | Condition 2 | 121 | PRODMST | Product Moisture | 51.96 | % | 0.1 | 51.96 | 51.96 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 0 | 1 | | 12 | TOB07 | PT | Smokeless01 | Condition 2 | 122 | PRODMST | Product Moisture | 51.98 | % | 0.1 | 51.98 | 51.98 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 0 | 1 | | 13 | TOB07 | PT | Smokeless01 | Condition 2 | 123 | PRODMST | Product Moisture | 51.80 | % | 0.1 | 51.80 | 51.80 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 8 | 42 | | 14 | TOB07 | PT | Smokeless01 | Condition 2 | 124 | PRODMST | Product Moisture | 51.77 | % | 0.1 | 51.77 | 51.77 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 8 | 42 | | 15 | TOB07 | PT | Smokeless01 | Condition 2 | 125 | PRODMST | Product Moisture | 51.84 | % | 0.1 | 51.84 | 51.84 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 8 | 42 | | 16 | TOB07 | PT | Smokeless01 | Condition 2 | 126 | PRODMST | Product Moisture | 52.18 | % | 0.1 | 52.18 | 52.18 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 1 | Week 4824 | 93 | | 17 | TOB07 | PT | Smokeless01 | Condition 2 | 127 | PRODMST | Product Moisture | 52.21 | % | 0.1 | 52.21 | 52.21 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 2 | Week 4824 | 93 | | 18 | TOB07 | PT | Smokeless01 | Condition 2 | 128 | PRODMST | Product Moisture | 51.87 | % | 0.1 | 51.87 | 51.87 | % | TLT07_V1 | TPT LABCO | TOBACCO | AS-IS | 0.12 | 3 | Week 4824 | 93 |
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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 above 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.xpt dataset below shows all three sets of storage conditions used across both pt.xpt dataset examples above..
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