- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct
sponsor applicant designations as specified in the trial design. - During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
- Smoke fraction? is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
- Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
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Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | NRU | TX | CSC-50 | CSC-50 | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 |
2 | 123 | NRU | TX | CSC-50 | CSC-50 | 2 | WELLNUM (e.g., 1-A through 10-H) | Number representing the location of the well in a multiple-well plate | 2-B |
3 | 123 | NRU | TX | CSC-50 | CSC-50 | 4 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | PRODUCT |
123 | NRU | TX | CSC-50 | CSC-50 | 5 | ITVCONC | intervention concentration | 50 | 123 | NRU | TX | CSC-50 | CSC-50 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | CSC-50 | CSC-50 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | CSC-50 | CSC-50 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | CSC-50 | CSC-50 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | CSC-50 | CSC-50 | 10 | RUN | Assay run number | 1 | 123 | NRU | TX | CSC-50 | CSC-50 | 11 | SMPLID | Sample ID | 030001 | 123 | NRU | TX | CSC-50 | CSC-50 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 123 | NRU | TX | CSC-50 | CSC-50 | 13 | REPNUM | Replicate Number | 1 | 123 | NRU | TX | CSC-50 | CSC-50 | 14 | TRTDMIN | Treatment Duration Min | 47.5 | 123 | NRU | TX | CSC-50 | CSC-50 | 15 | TRTDTRG | Treatment Duration Target | 48 | 123 | NRU | TX | CSC-50 | CSC-50 | 16 | TRTDMAX | Treatment Duration Max | 48.5 | 123 | NRU | TX | CSC-50 | CSC-50 | 17 | TRTDU | Treatment Duration Unit | HOURS | 123 | NRU | TX | CSC-50 | CSC-50 | 18 | INCBTMP | Incubation Temperature | 37 | 123 | NRU | TX | CSC-50 | CSC-50 | 19 | INCBTMPU | Incubation Temperature Unit | C
| WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 | 123 | NRU | TX | CSC-50 | CSC-50 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 | 123 | NRU | TX | CSC-50 | CSC-50 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | NRU | TX | CSC-50 | CSC-50 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | CSC-50 | CSC-50 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 123 | NRU | TX | CSC-50 | CSC-50 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | 123 | NRU | TX | CSC-50 | CSC-50 | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 | 123 | NRU | TX | CSC-50 | CSC-50 | 2 | WELLNUM (e.g., 1-A through 10-H) | Number representing the location of the well in the 96-well plate | 1-A | 123 | NRU | TX | CSC-50 | CSC-50 | 3 | INTRVN | name of the intervention article | Cigarette Smoke Condensate | 123 | NRU | TX | CSC-50 | CSC-50 | 4 | ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT | 123 | NRU | TX | CSC-50 | CSC-50 | 5 | ITVCONC | intervention concentration | 10 | 123 | NRU | TX | CSC-50 | CSC-50 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | CSC-50 | CSC-50 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | CSC-50 | CSC-50 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | CSC-50 | CSC-50 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | CSC-50 | CSC-50 | 10 | RUN | Assay run number | 1 | 123 | NRU | Dataset2 |
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ROW | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | TX | NRU | NRU_ASSAY | 1 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 2 | 123 | TX | NRU | NRU_ASSAY | 2 | IVTDTRG | In vitro Treatment Duration Target | 48 | 3 | 123 | TX | NRU | NRU_ASSAY | 3 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 4 | 123 | TX | NRU | NRU_ASSAY | 4 | IVTDU | In vitro Treatment Duration Unit | HOURS | 5 | 123 | TX | NRU | NRU_ASSAY | 5 | INCBTMP | Incubation Temperature | 37 | 6 | 123 | TX | NRU | NRU_ASSAY | 6 | INCBTMPU | Incubation Temperature Unit | C | 7 | 123 | TX | NRU | NRU_ASSAY | 7 | SWAVENM | Spectrophotometer Wavelength | 540 | 8 | 123 | TX | NRU | NRU_ASSAY | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 9 | 123 | TX | NRU | NRU_ASSAY | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | 10 | 123 | TX | NRU | NRU_ASSAY | 10 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 11 | 123 | TX | NRU | NRU_ASSAY | 11 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 12 | 123 | TX | NRU | NRU_ASSAY | 12 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 13 | 123 | TX | CSC-50b | CSC-50-blank | 13 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 14 | 123 | TX | CSC-50b | CSC-50-blank | 14 | IVTDTRG | In vitro Treatment Duration Target | 48 | 15 | 123 | TX | CSC-50b | CSC-50-blank | 15 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 16 | 123 | TX | CSC-50b | CSC-50-blank | 16 | IVTDU | In vitro Treatment Duration Unit | HOURS | 17 | 123 | TX | CSC-50b | CSC-50-blank | 17 | INCBTMP | Incubation Temperature | 37 | 18 | 123 | TX | CSC-50b | CSC-50-blank | 18 | INCBTMPU | Incubation Temperature Unit | C | 19 | 123 | TX | CSC-50b | CSC-50-blank | 19 | SWAVENM | Spectrophotometer Wavelength | 540 | 20 | 123 | TX | CSC-50b | CSC-50-blank | 20 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 21 | 123 | TX | CSC-50b | CSC-50-blank | 21 | ATMCO2P | Atmospheric CO2 Percent | 5 | 22 | 123 | TX | CSC-50b | CSC-50-blank | 22 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 23 | 123 | TX | CSC-50b | CSC-50-blank | 23 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 24 | 123 | TX | CSC-50b | CSC-50-blank | 24 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 25 | 123 | TX | CSC-50b | CSC-50-blank | 25 | EXPTYP | Exposure Type | Air Liquid Interface | 26 | 123 | TX | CSC-50b | CSC-50-blank | 26 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | 27 | 123 | TX | CSC-50b | CSC-50-blank | 27 | ITVNAM | Name of the Intervention Article | Tobacco ProdA | 28 | 123 | TX | CSC-50b | CSC-50-blank | 28 | ITVTYPE | Intervention Article Type | PRODUCT | 29 | 123 | TX | CSC-50b | CSC-50-blank | 29 | ITVCONC | Intervention Article Concentration | 50 | 30 | 123 | TX | CSC-50b | CSC-50-blank | 30 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 31 | 123 | TX | CSC-50b | CSC-50-blank | 31 | CELLLN | Cell Line | NOT APPLICABLE | 32 | 123 |
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11SMPLID | Sample ID | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 33 |
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030001NRU | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 33 | IVTDTRG | In vitro Treatment Duration Target | 48 | 34 | 123 |
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123 | NRU13 | REPNUM | Replicate Number | 1 | 123 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 35 | 123 |
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NRU14TRTDMINIVTDU | In vitro Treatment Duration |
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Min47.5NRU | 15TRTDTRG | Treatment Duration Target | INCBTMP | Incubation Temperature | 37 | 37 |
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48NRU | 16 | TRTDMAX | Treatment Duration Max | 37 | INCBTMPU | Incubation Temperature Unit | C | 38 |
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48.5NRU | 17 | TRTDU | Treatment Duration Unit | HOURS | 38 | SWAVENM | Spectrophotometer Wavelength | 540 | 39 | 123 |
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123 | NRU18 | INCBTMP | Incubation Temperature | 39 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 40 |
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37NRU | 19INCBTMPU | Incubation Temperature Unit | Atmospheric CO2 Percent | 5 | 41 |
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CNRU123 | NRU | TX | 20 | MEDIA | Composition of Media | Sartorius HEK293 | 21 | HUMID | Atmospheric Relative Humidity Percent | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 42 |
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90NRU | 22ATMCO2 | Atmospheric CO2 Percent | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 43 |
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5NRU | 23Sponsor Applicant-defined tobacco identifier | CIG01a | 44 | 123 |
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NRU | 2444 | EXPTYP | Exposure Type | Air Liquid Interface | 45 | 123 |
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NRU | 25123 | NRU | TX | SLS-110 | SLS-110 | 3 | INTRVN | name of the intervention article | sodium laurel sulfate | 123 | NRU | TX | SLS-110 | SLS-110 | 4 | ITVTYPE | type of intervention article | POSITIVE CONTROL | 123 | NRU | TX | SLS-110 | SLS-110 | 5 | ITVCONC | intervention concentration | 200 | 123 | NRU | 45 | SAMTYP | Sample Type | Whole Smoke Conditioned Media |
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... | ... | 123 | NRU | TX | SLS-110 | SLS-110 | 1 | PLATENUM | Plate number | 1 | 123 | NRU | TX | SLS-110 | SLS-110 | 2 | WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | 46 | 123 | TX | CSC-50 | CSC-50 | 46 | ITVNAM | Intervention Article Name | Tobacco ProdA | 47 | 123 | TX | CSC-50 | CSC-50 | 47 | ITVTYPE | Intervention Article Type | PRODUCT | 48 | 123 | TX | CSC-50 | CSC-50 | 48 | ITVCONC | Intervention Article Concentration | 50 | 49 | 123 | TX | CSC-50 | CSC-50 | 49 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 50 | 123 | TX | CSC-50 | CSC-50 | 50 | CELLLN | Cell Line | NHK | 51 | 123 |
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6ITVCONCU | intervention unit | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 52 |
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ug/mlNRU | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 52 | IVTDTRG | In vitro Treatment Duration Target | 48 | 53 | 123 |
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123 | NRU8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 54 | 123 |
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123 | NRU9 | DUREFID | Smoking Regime | 54 | IVTDU | In vitro Treatment Duration Unit | HOURS | 55 |
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Medium Intensity RegimenNRUTX | 10RUN | Assay run number | Incubation Temperature | 37 | 56 |
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1NRU11SMPLID | Sample ID | Incubation Temperature Unit | C | 57 |
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030001NRU | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO57 | SWAVENM | Spectrophotometer Wavelength | 540 | 58 | 123 |
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NRU | 13 | REPNUM | Replicate Number | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 59 |
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1NRU | 1447.TRTDMIN | Treatment Duration Min | ATMCO2P | Atmospheric CO2 Percent |
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NRU | 15 | TRTDTRG | Treatment Duration Target | 60 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 61 |
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48NRU | 16 | TRTDMAX | Treatment Duration Max | 61 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 62 |
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48.5NRU | 17 | TRTDU | Treatment Duration Unit | HOURS | 62 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 63 | 123 |
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123 | NRU18INCBTMPIncubation Temperature | 37 | Exposure Type | Air Liquid Interface | 64 | 123 |
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NRU | 19INCBTMPU | Incubation Temperature Unit | CNRU20MEDIA | Composition of Media | Sartorius HEK293 | Intervention Article Name | Sodium Laurel Sulfate | 66 | 123 |
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123 | NRU21HUMID | Atmospheric Relative Humidity Percent | 90 | Intervention Article Type | POSITIVE CONTROL | 67 | 123 |
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123 | NRU22ATMCO2 | Atmospheric CO2 Percent | Intervention Article Concentration | | 68 |
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5NRU | 23SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | SLS-110 | SLS-110 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 123 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 69 | 123 |
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NRU25SAMTYPSample Type | Whole Smoke Conditioned Media | ... | 123 | NRU | TX | SLS-110 | SLS-110 | 1 | PLATENUM | Plate number | 2 | 123 | NRU | TX | SLS-110 | SLS-110 | 2 | WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | 123 | NRU | TX | SLS-110 | SLS-110 | 3 | INTRVN | name of the intervention article | sodium laurel sulfate | 123 | NRU | TX | SLS-110 | SLS-110 | 4 | ITVTYPE | type of intervention article | POSITIVE CONTROL | 123 | NRU | TX | SLS-110 | SLS-110 | 5 | ITVCONC | intervention concentration | 200 | 123 | NRU | TX | SLS-110 | SLS-110 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | SLS-110 | SLS-110 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | SLS-110 | SLS-110 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | SLS-110 | SLS-110 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | SLS-110 | SLS-110 | 10 | RUN | Assay run number | 1 | 123 | NRU | TX | SLS-110 | SLS-110 | 11 | SMPLID | Sample ID | 030001 | 123 | NRU | TX | SLS-110 | SLS-110 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 123 | NRU | TX | SLS-110 | SLS-110 | 13 | REPNUM | Replicate Number | 1 | 123 | NRU | TX | SLS-110 | SLS-110 | 14 | TRTDMIN | Treatment Duration Min | 47.5 | 123 | NRU | TX | SLS-110 | SLS-110 | 15 | TRTDTRG | Treatment Duration Target | 48 | 123 | NRU | TX | SLS-110 | SLS-110 | 16 | TRTDMAX | Treatment Duration Max | 48.5 | 123 | NRU | TX | SLS-110 | SLS-110 | 17 | TRTDU | Treatment Duration Unit | HOURS | 123 | NRU | TX | SLS-110 | SLS-110 | 18 | INCBTMP | Incubation Temperature | 37 | 123 | NRU | TX | SLS-110 | SLS-110 | 19 | INCBTMPU | Incubation Temperature Unit | C
| 123 | NRU | TX | SLS-110 | SLS-110 | 20 | MEDIA | Composition of Media | Sartorius HEK293 | 123 | NRU | TX | SLS-110 | SLS-110 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 | 123 | NRU | TX | SLS-110 | SLS-110 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | NRU | TX | SLS-110 | SLS-110 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | SLS-110 | SLS-110 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 123 | NRU | TX | SLS-110 | SLS-110 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | ... |