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 | PTSEQ | PTREFID | PARQUAL | PARAM | PARAMCD | AVAL | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTLLOQ | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOB07 | Smokeless01 | 1 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | % | % | TOBACCO | |||||||
| S.D. | STD | |||||||||||||||||
| % RSD | PCTRSD | |||||||||||||||||
| TOB07 | Smokeless01 | 2 | TOB77777.1 | pH | S.D. | pH | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | TOBACCO | |||||||||
| TOB07 | Smokeless01 | 3 | TOB77777.1 | Water Activity | Water Activity | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | TOBACCO | ||||||||||
| TOB07 | Smokeless01 | 4 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | ||||||
| TOB07 | Smokeless01 | 5 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | ||||||
| TOB07 | Smokeless01 | 6 | TOB77777.1 | N-nitrosonornicotine | NNN | N-nitrosonornicotine | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | ||||||
| TOB07 | Smokeless01 | 7 | TOB77777.1 | N-nitrosonornicotine | NNN | N-nitrosonornicotine | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | ||||||
| TOB07 | Smokeless01 | 8 | TOB77777.1 | Tobacco-specific nitrosamines | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | FRESH | ||||||
| TOB07 | Smokeless01 | 9 | TOB77777.1 | Tobacco-specific nitrosamines | TSNA | Tobacco-specific nitrosamines | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | ng/g | ng/g | TOBACCO | DRIED | ||||||
| TOB07 | Smokeless01 | 10 | TOB77777.1 | Aerobic Plate Count | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | TOBACCO | |||||||||
| TOB07 | Smokeless01 | 11 | TOB77777.1 | Mold | MOLD | Mold | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | TOBACCO | |||||||||
| TOB07 | Smokeless01 | 12 | TOB77777.1 | Yeast | YEAST | Yeast | STABILITY STUDY | Condition 1 (X°C/ Z% RH) | TOBACCO |
| 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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