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NOTE: THIS SECTION MAY CHANGE . DEVICE DOMAIN MAY BE USED TO REPRESENT THE SMOKING MACHINE PARAMETERS Fix MATRIX variable |
Tobacco product stability study results are represented in PT. These are just the data that show the testing results under specific storage conditions and smoking regimens. The details of the regimen and storage conditions are shown in separate datasets that follow this example.
- The smoking regimen is carried out by the smoking machine/device shown in SPDEVID (sponsor-defined device identifier).
- The storage condition is represented in STOCONID (Storage condition identifier- this variable as created after consultation with our internal standards modeling team).
- The smoking regimen is represented in PTREFID (we made up a value; we can update with something realistic)
- We got buy-in on using a new variable, "PTMATRIX" (for the sample matrix), since the existing SDTM "specimen type" variable was not appropriate.
https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
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| Dataset2 |
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| Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
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| 1 | TOB07 | ES | Condition 1 | 1 | ISOSTNUM | ISO Standard Number | ISO 3308 |
| | 2 | TOB07 | ES | Condition 1 | 2 | PUFFVOL | Puff Duration | PT2S |
| | 3 | TOB07 | ES | Condition 1 | 3 | PUFFVOL | Puff Volume | 35 | mg | | 4 | TOB07 | ES | Condition 2 | 1 | PUFFDUR | Puff Duration | PT2S |
| | 5 | TOB07 | ES | Condition 2 | 2 | SMOKMAC | Smoking Machine | Big |
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Next ,we use DU (device-in use properties/settings) for smoking regimen. Note that the separate DI (device identifiers) dataset is needed to show identifying parameters of the "PUFFMASTER3K" smoking machine. We cannot have DU without also including DI).
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | Smoking Machine |
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| 2 | TOB07 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme |
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| 3 | TOB07 | DI | PUFFMASTER3K | 3 | TRADENAM | Trade Name | PuffMaster 3000 |
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Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
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| Dataset2 |
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| STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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| 1 | TOB07 | DU | PUFFMASTER3K | 1 | Medium Intensity Regimen |
| PUFFPROF | Puff Profile | SQUARE |
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| | 2 | TOB07 | DU | PUFFMASTER3K | 2 | Medium Intensity Regimen |
| PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | | 3 | TOB07 | DU | PUFFMASTER3K | 3 | Medium Intensity Regimen |
| PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | | 4 | TOB07 | DU | PUFFMASTER3K | 4 | Medium Intensity Regimen |
| PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | | 5 | TOB07 | DU | PUFFMASTER3K | 5 | Medium Intensity Regimen |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | | 6 | TOB07 | DU | PUFFMASTER3K | 6 | Medium Intensity Regimen |
| PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | | 7 | TOB07 | DU | PUFFMASTER3K | 7 | Medium Intensity Regimen |
| PUFFRNG | Puff Range | 100-200 |
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| | 8 | TOB07 | DU | PUFFMASTER3K | 8 | Medium Intensity Regimen | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | | 9 | TOB07 | DU | PUFFMASTER3K | 9 | Medium Intensity Regimen | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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Finally, we assume we still need to parse out storage conditions of "E-Liquid Standard (Long Term) Condition". Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset.
- The variable STOCONID (Storage Condition ID) = "E-Liquid Standard (Long Term) Condition". Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
- These values were made up, but we assume they'd look something like this.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
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| 1 | TOB07 | ES | E-Liquid Standard (Long Term) Condition | 1 | HUMID | Humidity | 38 | % | | 2 | TOB07 | ES | E-Liquid Standard (Long Term) Condition | 2 | TEMP | Temperature | 25 | C |
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