This example will need to be udated following the ENDS stability study approach, which was created to reflect recent developments and consultation with CDISC ISMT
The following example illustrates calculation of some of the statistics typically calculated on product stability measures.
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | PT.STUDYID | |
| USUBJID | Unique Subject Identifier | Char | Req | N/A | |
| TRTP | Planned Treatment | Char | Cond | N/A | |
| TRTA | Actual Treatment | Char | Cond | N/A | |
| PARQUAL | |||||
| PARAM | Parameter | Char | Req | ||
| PARAMCD | Parameter Code | text | Req | ||
| PARCAT1 | Parameter Category 1 | Char | Perm | PT.PTCAT | |
| AVAL | Analysis Value | Num | Cond | see parameter level metadata | |
| PTSEQ | Sequence Number | Num | Perm | PT.PTSEQ |
ADPT
| STUDYID | SPTOBID | PTREFID | PARQUAL | PARAM | PARAMCD | AVAL | PTTSTCND | PTSEQ |
|---|---|---|---|---|---|---|---|---|
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 1 | |
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | S.D. | STD | Condition 1 (X°C/ Z% RH) | 1 | |
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 1 | |
| TOB07 | Smokeless01 | TOB77777.1 | pH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 2 | |
| TOB07 | Smokeless01 | TOB77777.1 | pH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 2 | |
| TOB07 | Smokeless01 | TOB77777.1 | pH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 2 | |
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 3 | |
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | S.D. | STD | Condition 1 (X°C/ Z% RH) | 3 | |
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 3 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 4 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 4 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 4 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 5 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 5 | |
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 5 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 6 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 6 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 6 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 7 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 7 | |
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 7 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 8 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 8 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 8 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 9 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 9 | |
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 9 | |
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 10 | |
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | S.D. | STD | Condition 1 (X°C/ Z% RH) | 10 | |
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 10 | |
| TOB07 | Smokeless01 | TOB77777.1 | Mold | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 11 | |
| TOB07 | Smokeless01 | TOB77777.1 | Mold | S.D. | STD | Condition 1 (X°C/ Z% RH) | 11 | |
| TOB07 | Smokeless01 | TOB77777.1 | Mold | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 11 | |
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 12 | |
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | S.D. | STD | Condition 1 (X°C/ Z% RH) | 12 | |
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 12 |
| param1 | paramval1 | param2 | paramval2 | colvar1 | colvar2 | colvaltyp | colval | colvalu | colord |
shelf life factor | Product Moisture | statistic | Average | Condition 1 (X°C/ Z% RH) | Week 0 | text? | xxx.x | % | 1 |
shelf life factor | Product Moisture | statistic | S.D. | Condition 1 (X°C/ Z% RH) | Week 0 | xxx.xx | % | 1 | |
shelf life factor | Product Moisture | statistic | % RSD | Condition 1 (X°C/ Z% RH) | Week 0 | xxx.x | % | 1 | |
shelf life factor | Product Moisture | statistic | Average | Condition 2 (A °C/ B %RH) | Week 0 | xxx.x | % | 10 | |
shelf life factor | Product Moisture | statistic | S.D. | Condition 2 (A °C/ B %RH) | Week 0 | xxx.xx | % | 10 | |
shelf life factor | Product Moisture | statistic | % RSD | Condition 2 (A °C/ B %RH) | Week 0 | xxx.x | % | 10 |
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