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 and PTSPCCND). 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.
- 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 / parameter when such methodology is too complex for the single PTMETHOD variable.
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Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.
| 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 used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Product Moisture (see Row 3). |
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| 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. |
Dataset Wrapper Debug Message
Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.
| 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 used in chemistry stability studies. For microbial stability studies, Water Activity should be used, not Product Moisture (see Row 3). |
|---|---|
| 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. |
Unable to render dataset table
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TOBA-255 - Getting issue details... STATUS
| Row | STUDYID | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTTESTCD | PTTEST | PTCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTXFN | PTNAM | PTSPEC | PTSPCCND | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 8.06 | 8.06 | TL009_V1 | TPT LABCO | TOBACCO | 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 | 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 | 0.05 | 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 | 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 | DRIED | 0.05 | 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 | 1 | <10 | CFU/g | TLMB_V1.1 | TPT LABCO | TOBACCO | 1 | 1 | Week 0 | 1 |
The second pt.xpt dataset shows testing for just one parameter, product moisture, TOBA-157 - Getting issue details... STATUS performed in three replicates (note the values of PTREPNUM), at the first three time points of the study (as shown in PTTPT / PTTPTNUM), from two 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.
- Details of the storage conditions are represented in the ES dataset example that follows below.
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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 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 both sets of storage conditions used across both pt.xpt dataset examples above.
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