- 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 | 1-2-B(plate-col-row in the 96-well plate) | CSC-50(through SLS-200) | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 |
2 | 123 | NRU | TX | 1-2-B | 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 | 1-2-B | CSC-50 | 4 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | PRODUCT |
123 | NRU | TX | 1-2-B | CSC-50 | 5 | ITVCONC | intervention concentration | 50 | 123 | NRU | TX | 1-2-B | CSC-50 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | 1-2-B | CSC-50 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | 1-2-B | CSC-50 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | 1-2-B | CSC-50 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | 1-2-B | CSC-50 | 10 | RUN | Assay run number | 1 | 123 | NRU | TX | 1-2-B | CSC-50 | 11 | SMPLID | Sample ID | 030001 | 123 | NRU | TX | 1-2-B | CSC-50 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 123 | NRU | TX | 1-2-B | CSC-50 | 13 | REPNUM | Replicate Number | 1 | 123 | NRU | TX | 1-2-B | CSC-50 | 14 | TRTDMIN | Treatment Duration Min | 47.5 | 123 | NRU | TX | 1-2-B | CSC-50 | 15 | TRTDTRG | Treatment Duration Target | 48 | 123 | NRU | TX | 1-2-B | CSC-50 | 16 | TRTDMAX | Treatment Duration Max | 48.5 | 123 | NRU | TX | 1-2-B | CSC-50 | 17 | TRTDU | Treatment Duration Unit | HOURS | 123 | NRU | TX | 1-2-B | CSC-50 | 18 | INCBTMP | Incubation Temperature | 37 | 123 | NRU | TX | 1-2-B | CSC-50 | 19 | INCBTMPU | Incubation Temperature Unit | C
| 123 | NRU | TX | 1-2-B | CSC-50 | 20 | MEDIA | Composition of Media | Sartorius HEK293 | WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 | 123 | NRU | TX | 1-2-B | CSC-50 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 | 123 | NRU | TX | 1-2-B | CSC-50 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | NRU | TX | 1-2-B | CSC-50 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | 1-2-B | CSC-50 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 123 | NRU | TX | 1-2-B | CSC-50 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | 123 | NRU | TX | 1-2-C | CSC-50 | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 | 123 | NRU | TX | 1-2-C | 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 | 1-2-C | CSC-50 | 3 | INTRVN | name of the intervention article | Cigarette Smoke Condensate | 123 | NRU | TX | 1-2-C | CSC-50 | 4 | ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT | 123 | NRU | TX | 1-2-C | CSC-50 | 5 | ITVCONC | intervention concentration | 10 | 123 | NRU | TX | 1-2-C | CSC-50 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | 1-2-C | CSC-50 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | 1-2-C | CSC-50 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | 1-2-C | CSC-50 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | 1-2-C | CSC-50 | 10 | RUN | Assay run number | 1 | 123 | NRU | TX | 1-2-C | CSC-50 | 11 | SMPLID | Sample ID | 030001 | 123 | NRU | TX | 1-2-C | CSC-50 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 123 | NRU | TX | 1-2-C | CSC-50 | 13 | REPNUM | Replicate Number | 1 | 123 | NRU | TX | 1-2-C | CSC-50 | 14 | TRTDMIN | Treatment Duration Min | 47.5 | 123 | NRU | TX | 1-2-C | CSC-50 | 15 | TRTDTRG | Treatment Duration Target | 48 | 123 | NRU | TX | 1-2-C | CSC-50 | 16 | TRTDMAX | Treatment Duration Max | 48.5 | 123 | NRU | TX | 1-2-C | CSC-50 | 17 | TRTDU | Treatment Duration Unit | HOURS | 123 | NRU | TX | 1-2-C | CSC-50 | 18 | INCBTMP | Incubation Temperature | 37 | 123 | NRU | TX | 1-2-C | CSC-50 | 19 | INCBTMPU | Incubation Temperature Unit | C
| 123 | NRU | TX | 1-2-C | 20 | MEDIA | Composition of Media | Sartorius HEK293 | 123 | NRU | TX | 1-2-C | CSC-50 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 | 123 | NRU | TX | 1-2-C | CSC-50 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | NRU | TX | 1-2-C | CSC-50 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | 1-10-H | CSC-50 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 45 | 123 |
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NRU | 110-H2545 | SAMTYP | Sample Type | Whole Smoke Conditioned Media |
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... | ...NRU110HSLS-1101PLATENUM | Plate number | 1 Intervention Article Name | Tobacco ProdA | 47 | 123 |
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NRU110HSLS-1102WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | Intervention Article Type | PRODUCT | 48 | 123 |
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123 | NRU110-HSLS1103INTRVN | name of the intervention article | sodium laurel sulfateITVCONC | Intervention Article Concentration | 50 | 49 | 123 |
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NRU | 110HSLS-1104 | ITVTYPE | type of intervention article | POSITIVE CONTROL | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 50 | 123 |
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123 | NRU110HSLS-1105ITVCONCintervention concentration200NRU110-H6 | ITVCONCU | intervention unit | ug/ml | 123 | 51 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 52 | 123 |
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NRU110-H7 | STRAIN | Strain/Substrain | 52 | IVTDTRG | In vitro Treatment Duration Target | 48 | 53 |
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Salmonella enterica entericaNRU | 110-H8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 53 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 54 | 123 |
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123 | NRU110-H9 | DUREFID | Smoking Regime | Medium Intensity Regimen | IVTDU | In vitro Treatment Duration Unit | HOURS | 55 | 123 |
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123 | NRU110-H10 | RUN | Assay run number | 1 | 55 | INCBTMP | Incubation Temperature | 37 | 56 | 123 |
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123 | NRU110-H11 | SMPLID | Sample ID | 030001 | 123 | 56 | INCBTMPU | Incubation Temperature Unit | C | 57 | 123 |
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NRU110-H12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 57 | SWAVENM | Spectrophotometer Wavelength | 540 | 58 | 123 |
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123 | NRU110-H13 | REPNUM | Replicate Number | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 59 |
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1NRU | 110-H1447.TRTDMIN | Treatment Duration Min | ATMCO2P | Atmospheric CO2 Percent |
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NRU | 110-H15TRTDTRG | Treatment Duration Target | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 61 |
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48NRU | 110-H16TRTDMAX | Treatment Duration Max | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 62 |
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48.5NRU | 110-H17 | TRTDU | Treatment Duration Unit | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 63 |
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HOURSNRU | 110-H18INCBTMPIncubation Temperature | 37 | 123 | Exposure Type | Air Liquid Interface | 64 | 123 |
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NRU110-H19 | INCBTMPU | Incubation Temperature Unit | 64 | SAMTYP | Sample Type | Liquid | 65 |
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CNRU | 110-H20 | MEDIA | Composition of Media | 65 | ITVNAM | Intervention Article Name | Sodium Laurel Sulfate | 66 |
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Sartorius HEK293NRU | 110-H21 | HUMID | Atmospheric Relative Humidity Percent | 66 | ITVTYPE | Intervention Article Type | POSITIVE CONTROL | 67 |
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90NRU1-10-HTX | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | 67 | ITVCONC | Intervention Article Concentration | | 68 | 123 |
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NRU110-H23 | SPTOBID | Sponsor defined tobacco identifier | 68 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 69 |
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CIG01aNRU | 110-H24EXPTYPExposure Type | Air Liquid Interface | 123 | NRU | TX | 1-10-H | SLS-110 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | ... | ... | 123 | NRU | TX | 2-10-H | SLS-110 | 1 | PLATENUM | Plate number | 2 | 123 | NRU | TX | 2-10-H | SLS-110 | 2 | WELLNUM | Number representing the location of the well in the 96-well plate | 10-H | 123 | NRU | TX | 2-10-H | SLS-110 | 3 | INTRVN | name of the intervention article | sodium laurel sulfate | 123 | NRU | TX | 2-10-H | SLS-110 | 4 | ITVTYPE | type of intervention article | POSITIVE CONTROL | 123 | NRU | TX | 2-10-H | SLS-110 | 5 | ITVCONC | intervention concentration | 200 | 123 | NRU | TX | 2-10-H | SLS-110 | 6 | ITVCONCU | intervention unit | ug/ml | 123 | NRU | TX | 2-10-H | SLS-110 | 7 | STRAIN | Strain/Substrain | Salmonella enterica enterica | 123 | NRU | TX | 2-10-H | SLS-110 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | 123 | NRU | TX | 2-10-H | SLS-110 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen | 123 | NRU | TX | 2-10-H | SLS-110 | 10 | RUN | Assay run number | 1 | 123 | NRU | TX | 2-10-H | SLS-110 | 11 | SMPLID | Sample ID | 030001 | 123 | NRU | TX | 2-10-H | SLS-110 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO | 123 | NRU | TX | 2-10-H | SLS-110 | 13 | REPNUM | Replicate Number | 1 | 123 | NRU | TX | 2-10-H | SLS-110 | 14 | TRTDMIN | Treatment Duration Min | 47.5 | 123 | NRU | TX | 2-10-H | SLS-110 | 15 | TRTDTRG | Treatment Duration Target | 48 | 123 | NRU | TX | 2-10-H | SLS-110 | 16 | TRTDMAX | Treatment Duration Max | 48.5 | 123 | NRU | TX | 2-10-H | SLS-110 | 17 | TRTDU | Treatment Duration Unit | HOURS | 123 | NRU | TX | 2-10-H | SLS-110 | 18 | INCBTMP | Incubation Temperature | 37 | 123 | NRU | TX | 2-10-H | SLS-110 | 19 | INCBTMPU | Incubation Temperature Unit | C
| 123 | NRU | TX | 2-10-H | SLS-110 | 20 | MEDIA | Composition of Media | Sartorius HEK293 | 123 | NRU | TX | 2-10-H | SLS-110 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 | 123 | NRU | TX | 2-10-H | SLS-110 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 | 123 | NRU | TX | 2-10-H | SLS-110 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | 123 | NRU | TX | 2-10-H | SLS-110 | 24 | EXPTYP | Exposure Type | Air Liquid Interface | 123 | NRU | TX | 2-10-H | SLS-110 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | ... |