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- 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://www.ecigstats.org/docs/research/CoA_1R6F.pdf - This is a sample Smoking Regime that was used as the basis of the example.
https://open.canada.ca/data/en/dataset/71394df3-aee8-4117-92cb-a035360972a2/resource/7e6b0457-051e-4620-befc-8e4f50b75345
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This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sponsor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset. These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.
Dataset wrap |
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Rowcaps |
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Rows 1-15: | Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. | Row 16: | Shows the HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. |
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Dataset2 |
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Row | STUDYID |
| DOMAIN |
| SPTOBID | SPDEVID | STOCONID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM | PTDTC |
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1 | Row |
| STUDYID |
| DOMAIN | SPTOBID | PTSEQ | PTREFID | PTCSREFID | PTTESTCD | Analyte | PTTSTDTL | PTCAT | HPHC vs other constituents | PTORRES | Unit | Result | PTSTRESN | PTSTRESU | Method | Smoking Regime | Lab | Limit of Quantitation | PTREPNUM | PTDTC |
| 2 |
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| PTTEST |
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| PTSCAT |
| PTORRESU | PTSTRESC |
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| PTMETHOD | PTNAM | PTLLOQ |
|
| MATRIX | 3 | 1 |
| TOB07 |
| PT | CIG01a | 1 | Batch 101 | 75-07-0 | ACETALD | Acetaldehyde | QUANTITY | HPHC TESTING | HPHC | 522 | µg/cigarette |
|
| µg/cigarette | TL001 | ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 4 | 2 |
| TOB07 |
| PT | CIG01a | 2 | Batch 101 | 107-02-8 | ACROL | Acrolein | QUANTITY | HPHC TESTING | HPHC | 43 | µg/cigarette |
|
| µg/cigarette | TL002 | ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 5 | 3 |
| TOB07 |
| PT | CIG01a | 3 | Batch 101 | 107-13-1 | ACRLONI | Acrylonitrile | QUANTITY | HPHC TESTING | HPHC | 7 | µg/cigarette |
|
| µg/cigarette | TL006 | ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 6 | 4 |
| TOB07 |
| PT | CIG01a | 4 | Batch 101 | 92-67-1 | AMNPHEN4 | 4-Aminobiphenyl | QUANTITY | HPHC TESTING | HPHC | 1.2 | ng/cigarette |
|
| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 7 | 5 |
| TOB07 |
| PT | CIG01a | 5 | Batch 101 | 134-32-7 | AMNPHTH1 | 1-Aminonaphthalene | QUANTITY | HPHC TESTING | HPHC | 14 | ng/cigarette |
|
| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 8 |
|
| TOB07 |
| PT | CIG01a | 6 | Batch 101 | 134-32-7 | AMNPHTH2 | 2-Aminonaphthalene | QUANTITY | HPHC TESTING | HPHC | 8 | ng/cigarette |
|
| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 | | 1 | 2022-09-30 | SMOKE | 9 | 6 |
| TOB07 |
| PT | CIG01a | 7 | Batch 101 | 7664-41-7 | NH4 | Ammonia | QUANTITY | HPHC TESTING | HPHC | 9 | µg/cigarette |
|
| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 10 | 7 |
| TOB07 |
| PT | CIG01a | 8 | Batch 101 | 71-43-2 | BENZ | Benzene | QUANTITY | HPHC TESTING | HPHC | 33 | µg/cigarette |
|
| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 11 | 8 |
| TOB07 |
| PT | CIG01a | 9 | Batch 101 | 50-32-8 | BENZAP | Benzo[a]pyrene | QUANTITY | HPHC TESTING | HPHC | 6.8 | ng/cigarette |
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| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 12 | 9 |
| TOB07 |
| PT | CIG01a | 10 | Batch 101 | 630-08-0 | CO | Carbon monoxide | QUANTITY | HPHC TESTING | HPHC | 10.1 | mg/cigarette |
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| mg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 13 | 10 |
| TOB07 |
| PT | CIG01a | 11 | Batch 101 | 4170-30-3 | CROTALD | Crotonaldehyde | QUANTITY | HPHC TESTING | HPHC | 11 | µg/cigarette |
|
| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 14 | 11 |
| TOB07 |
| PT | CIG01a | 12 | Batch 101 | 50-00-0 | FORMALD | Formaldehyde | QUANTITY | HPHC TESTING | HPHC | 27 | µg/cigarette |
|
| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 15 | 12 |
| TOB07 |
| PT | CIG01a | 13 | Batch 101 | 78-79-5 | ISOPRN | Isoprene | QUANTITY | HPHC TESTING | HPHC | 320 | µg/cigarette |
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| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 16 | 13 |
| TOB07 |
| PT | CIG01a | 14 | Batch 101 | 1954-11-05 | NIC | Nicotine | QUANITY | HPHC TESTING | HPHC | 0.721 | mg/cigarette |
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| mg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 17 | 14 |
| TOB07 |
| PT | CIG01a | 15 | Batch 101 | 64091-91-4 | NNK | 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone | QUANTITY | HPHC TESTING | HPHC | 71 | ng/cigarette |
|
| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 18 | 15 |
| TOB07 |
| PT | CIG01a | 16 | Batch 101 | 16543-55-8 | NNN | N-nitrosonornicotine | QUANTITY | HPHC TESTING | HPHC | 85 | ng/cigarette |
|
| ng/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 19 |
|
| TOB07 |
| PT | CIG01a | 17 | Batch 101 | 108-88-3 |
| Toluene | QUANTITY | HPHC TESTING | HPHC | 53 | µg/cigarette |
|
| µg/cigarette |
| ISO METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 20 | 16 |
| TOB07 |
| PT | CIG01a | 18 | Batch 101 | 75-07-0 | ACETALD | Acetaldehyde | QUANTITY | HPHC TESTING | HPHC | 1552 | µg/cigarette |
|
| µg/cigarette |
| CANADIAN INTENSE METHOD | TOBACCO LAB 1 |
| 1 | 2022-09-30 | SMOKE | 21 | 17 |
| TOB07 |
| PT | CIG01a | 19 | Batch 101 | 7664-41-7 | AMMONIA | Ammonia | Quantity | HPHC TESTING | HPHC | 956 | µg/g |
| 612 | µg/cigarette |
| - |
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| 1 | 2022-09-30 | FILLER |
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the old example - from the original HPHC (as opposed to the one with the device and smoking regimen)
Dataset wrap |
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Rowcaps |
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Rows 1-15: | Show the HPHC testing performed on one sample of the product with SPTOBID CIG01a. The test condition are represented in PTTSTCND. | Row 16: | Shows the HPHC testing performed on one sample for one ingredient using the CANDIAN INTENSE test conditions. |
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM | PTDTC |
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1 | TOB07 | PT | CIG01a | | E-Liquid Standard (Long Term) Condition | |
| | | Sample 1 | ACETALD | | | HPHC | 1639 | ug/cigarette | 1639 | 1639 | ug/cigarette | SMOKE | ISO INTENSE METHOD | 1 | Week 0 | 1 | 2022-09-30 | 2 | TOB07 | PT | CIG01a | 2 |
| E-Liquid Standard (Long Term) Condition | 2 |
| 107-02-8Sample 1 | ACROL | Acrolein | HPHC TESTING | HPHC | 154 | ug/cigarette | 154 | 154 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
|
| 2022-09-30 | 3 | TOB07 | PT | CIG01a |
| E-Liquid Standard (Long Term) Condition | 3 |
| Sample 107-13-1 | ACRLONI | Acrylonitrile | | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 4 | TOB07 | PT | CIG01a |
| E-Liquid Standard (Long Term) Condition | 4 |
| Sample 92-67-1 | AMNPHEN4 | 4-Aminobiphenyl | HPHC TESTING | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 5 | TOB07 | PT | CIG01a | 5 |
| E-Liquid Standard (Long Term) Condition | 5 |
| 134-32-7Sample 1 | AMNPHTH1 | 1-Aminonaphthalene | | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 6 | TOB07 | PT | CIG01a |
| E-Liquid Standard (Long Term) Condition | 6Sample 1 |
| | NH4 | Ammonia | HPHC TESTING | HPHC | 29.2 | ug/cigarette | 29.2 | 29.2 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 7 | TOB07 | PT | CIG01a | 7 |
| E-Liquid Standard (Long Term) Condition | 7 |
| 71-43-2Sample 1 | BENZ | Benzene | | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 8 | TOB07 | PT | CIG01a |
| E-Liquid Standard (Long Term) Condition | 8Sample 1 |
| 50-32-8 | BENZAP | Benzo[a]pyrene | HPHC TESTING | HPHC | 30.5 | ug/cigarette | 30.5 | 30.5 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 9 | TOB07 | PT | CIG01a | 9 |
| E-Liquid Standard (Long Term) Condition | 9 |
| 630-08-0Sample 1 | CO | Carbon monoxide | | HPHC | 28.2 | ug/cigarette | 28.2 | 28.2 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 10 | TOB07 | PT | CIG01a | 10 |
| E-Liquid Standard (Long Term) Condition | 10 |
| 4170-30-3Sample 1 | CROTALD | Crotonaldehyde | HPHC TESTING | HPHC | 0.01 |
| 0.01 | 0.01 |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 11 | TOB07 | PT | CIG01a | 11 |
| E-Liquid Standard (Long Term) Condition | 11 |
| 50-00-0Sample 1 | FORMALD | Formaldehyde | | HPHC | 83.2 | ug/cigarette | 83.2 | 83.2 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 12 | TOB07 | PT | CIG01a |
| E-Liquid Standard (Long Term) Condition | 12Sample 1 |
| 78-79-5 | ISOPRN | Isoprene | HPHC TESTING | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 13 | TOB07 | PT | CIG01a | PUFFMASTER3K | E-Liquid Standard (Long Term) Condition | 13Sample 1 | Medium Intensity Regimen | 1954-11-05 | NIC | Nicotine | | HPHC | 1.71 | ug/cigarette | 1.71 | 1.71 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 14 | TOB07 | PT | CIG01a | PUFFMASTER3K | E-Liquid Standard (Long Term) Condition | 14Sample 1 | Medium Intensity Regimen | 64091-91-4 | NNK | Nicotine-derived Nitrosamine Ketone | HPHC TESTING | HPHC |
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| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 15 | TOB07 | PT | CIG01a | PUFFMASTER3K | E-Liquid Standard (Long Term) Condition | 15Sample 1 | Medium Intensity Regimen | | NNN | N-nitrosonornicotine | | HPHC | 284 | ug/cigarette | 284 | 284 | ug/cigarette |
| ISO INTENSE METHOD | 1 |
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| 2022-09-30 | 16 | TOB07 | PT | CIG01a | | | E-Liquid Standard (Long Term) Condition | |
| Sample 1 | ACETALD | | | HPHC | 1569 | ug/cigarette | 1569 | 1569 | ug/cigarette |
| CANADIAN INTENSE METHOD | 1 |
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| 2022-09-30 |
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The Environmental Storage Conditions (ES) dataset can be used to provide additional details on any test conditions or methods used to perform the testing.
Dataset wrap |
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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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