Page History
| Warning |
|---|
This example will need to be updated 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 | |||||||||||||||
| PRODSTID | Product Stability Identifier | Char | Req | Concatenate SPTOBID with STOCONID separated with '/' | |||||||||||||||
| SPTOBIDUSUBJID | Unique Subject Identifier | Char | Req | N/A | Perm | PT.SPTOBID | |||||||||||||
| STOCONIDTRTP | Planned Treatment | Char | Cond | N/A | Perm | PT.STOCONID | |||||||||||||
| PTREFIDTRTA | Actual Treatment | Char | Cond | Perm | PT.PTREFIDN/A | ||||||||||||||
| PARQUAL | Parameter Qualifier | Char | Cond | Set to the item being tested | |||||||||||||||
| PARAM | Parameter | Char | Req | Set to the parameter being captured | |||||||||||||||
| PARAMCD | Parameter Code | textChar | 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
| Set to the parameter code associated with the parameter | |||||
| AVAL | Analysis Value | Num | Req | Calculated statistic | |
| ATPT | Analysis Timepoint | Char | Cond | PT.PTTPT | |
| ATPTN | Analysis Timepoint (N) | Num | Cond | PT.PTTPTNUM |
ADPT
| STUDYID | PRODSTID | SPTOBID | STOCONID | STUDYID | SPTOBID | PTREFID | PARQUAL | PARAM | PARAMCD | AVAL | PTTSTCNDATPT | PTSEQATPTN | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | 51.95667 | Week 0Condition 1 (X°C/ Z% RH) | 1 | |||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.025166 | Week 0Condition 1 (X°C/ Z% RH) | 1 | |||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.048437 | Week 0Condition 1 (X°C/ Z% RH) | 1 | |||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01TOB77777./Condition 1 | pH | Average | AVERAGESmokeless01 | 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 | Product Moisture (%) | Average | AVERAGE | 51.72333 | Week 8 | 4 | |||||||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | 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 | 0.046188 | Week 8 | 4 | |||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESHProduct Moisture (%) | % RSD | PCTRSDCondition | 0.089298 | Week 8 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 | /Condition 1 | Smokeless01 | Condition 1Smokeless01 | 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 | Product Moisture (%) | Average | AVERAGE | 52.31333 | Week 48 | 9 | ||||||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | 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) | 0.327465 | Week 48 | 96 | ||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 1 | Smokeless01 | Condition 1 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESHProduct Moisture (%) | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 0.625969 | Week 48 | 96 | ||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 2 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIEDProduct Moisture (%) | Average | AVERAGE | 51.95667 | Week 0 | Condition 1 (X°C/ Z% RH) | 7 | TOB07 | |||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 2Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIEDProduct Moisture (%) | S.D. | STD | 0.025166 | Week 0 | Condition 1 (X°C/ Z% RH) | 7 | TOB07 | |||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIEDProduct Moisture (%) | % 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) | 0.048437 | Week 0 | 18 | ||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 8 | /Condition 2 | Smokeless01 | Condition 1 | 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 | Product Moisture (%) | Average | AVERAGE | 51.80333 | Week 8 | 4 | ||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIEDProduct Moisture (%) | S.D. | STD | Condition 1 (X°C/ Z% RH) | 0.035119 | Week 8 | 49 | ||||||||||||||||||||||||||||||||||||||||||||
| 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 | Condition 2 | Smokeless01 | Condition 1Smokeless01 | TOB77777.1 | Aerobic Plate Count | S.D. | STD | Condition 1 (X°C/ Z% RH) | 10 | Product Moisture (%) | TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 0.067793 | Week 8 | 410 | |||||||||||||||||||
| 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 | /Condition 2 | Smokeless01 | Condition 1 | TOB07 | Smokeless01 | TOB77777.1 | Mold | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 11 | TOB07 | Smokeless01 | TOB77777.1 | YeastProduct Moisture (%) | 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 | ||||||||||||||||||||||||||||||||||||||||||||||
| 52.08667 | Week 48 | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | S.D. | STD | 0.188237 | Week 48 | 9 | |||||||||||||||||||||||||||||||||||||||||||||
| TOB07 | Smokeless01/Condition 2 | Smokeless01 | Condition 1 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | 0.361393 | Week 48 | 9 | 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 |
Overview
Content Tools