- 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?
Rows 1-20: Show the values for the |
Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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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 |
|
1TRTDMIN | Treatment Duration Minimum | 47.5 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 23 | 123 |
|
2 | 123 | NRU2TRTDTRG | Treatment Duration Target | 48 | 3 | 123 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 24 | 123 |
|
NRU3TRTDMAX | Treatment Duration Maximum | 48.5 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 25 | 123 |
|
4 | 123 | NRU4TRTDU | Treatment Duration Unit | HOURS | EXPTYP | Exposure Type | Air Liquid Interface | 26 |
|
5NRU | 5INCBTMPIncubation Temperature | 37 | 6 | 123 | Sample Type | Whole Smoke Conditioned Media | 27 | 123 |
|
NRU6INCBTMPU | Incubation Temperature Unit | C
| 7 | 123 | ITVNAM | Name of the Intervention Article | Tobacco ProdA | 28 | 123 |
|
NRU7WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 | ITVTYPE | Intervention Article Type | PRODUCT | 29 | 123 |
|
8 | 123 | NRU8HUMID | Atmospheric Relative Humidity Percent | 90 | ITVCONC | Intervention Article Concentration | 50 | 30 | 123 |
|
9 | 123 | NRU9ATMCO2 | Atmospheric CO2 Percent | 5 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 31 |
|
10NRU | 10SPTOBID | Sponsor defined tobacco identifier | CIG01a | CELLLN | Cell Line | NOT APPLICABLE | 32 |
|
11NRU | 50b-blank11EXPTYP | Exposure Type | Air Liquid Interface | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 33 |
|
12NRU | 50b-blank12SAMTYP | Sample Type | Whole Smoke Conditioned Media | 13 | 123 | IVTDTRG | In vitro Treatment Duration Target | 48 | 34 | 123 |
|
NRU50b-blank13INTRVN | Name of the Intervention Article | Tobacco ProdA | 14 | 123 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 35 | 123 |
|
NRU50b-blank15 | 123 | NRU | 14 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | PRODUCT | 35 | IVTDU | In vitro Treatment Duration Unit | HOURS | 36 | 123 |
|
50b-blank15ITVCONCintervention concentration5016NRU | 50b-blank16ITVCONCU | intervention unit | ug/ml | INCBTMPU | Incubation Temperature Unit | C | 38 | 123 |
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17 | 123 | NRU50b-blank17STRAIN | Strain/Substrain | NO STRAIN | SWAVENM | Spectrophotometer Wavelength | 540 | 39 | 123 |
|
18 | 123 | NRU50b-blank18SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 40 |
|
19NRU | 50b-blank19DUREFID | Smoking Regime | Medium Intensity Regimen | ATMCO2P | Atmospheric CO2 Percent | 5 | 41 | 123 |
|
20 | 123 | NRU50b-blank20SPTOBIDSponsor tobacco CIG01a1NRU1TRTDMIN | Treatment Duration Minimum | 47.5 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 43 |
|
2NRU | 2TRTDTRG | Treatment Duration Target | 48 | 3 | 123 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 44 | 123 |
|
NRU3TRTDMAX | Treatment Duration Maximum | 48.5 | EXPTYP | Exposure Type | Air Liquid Interface | 45 | 123 |
|
4 | 123 | NRU4TRTDU | Treatment Duration Unit | HOURS | SAMTYP | Sample Type | Whole Smoke Conditioned Media | 46 | 123 |
|
5 | 123 | NRU5INCBTMP | Incubation Temperature | 37 | 6 | 123 | ITVNAM | Intervention Article Name | Tobacco ProdA | 47 | 123 |
|
NRU6INCBTMPU | Incubation Temperature Unit | C
| ITVTYPE | Intervention Article Type | PRODUCT | 48 |
|
7NRU | 7WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 | ITVCONC | Intervention Article Concentration | 50 | 49 |
|
8NRU | 8HUMID | Atmospheric Relative Humidity Percent | 90 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 50 |
|
9NRU | 9ATMCO2 | Atmospheric CO2 Percent | 5 | 10 | 123 | NRUCSC50CSC5010SPTOBID | Sponsor defined tobacco identifier | CIG01a | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | 52 |
|
11NRU | CSC50CSC5011EXPTYP | Exposure Type | Air Liquid Interface | IVTDTRG | In vitro Treatment Duration Target | 48 | 53 |
|
12NRU | CSC50CSC5013 | 123 | NRU | TX | CSC-50 | CSC-50 | 13 | INTRVN | Name of the Intervention Article | Tobacco ProdA |
14 | 123 | NRU | TX | CSC-50 | CSC-50 | 14 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | PRODUCT |
15 | 123 | NRU | TX | CSC-50 | CSC-50 | 15 | ITVCONC | intervention concentration | 50 |
16 | 123 | NRU | TX | CSC-50 | CSC-50 | 16 | ITVCONCU | intervention unit | ug/ml |
17 | 123 | NRU | TX | CSC-50 | CSC-50 | 17 | STRAIN | Strain/Substrain | CHO |
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18 | 123 | NRU | TX | CSC-50 | CSC-50 | 18 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
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19 | 123 | NRU | TX | CSC-50 | CSC-50 | 19 | DUREFID | Smoking Regime | Medium Intensity Regimen |
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20 | 123 | NRU | TX | CSC-50 | CSC-50 | 20 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
21 | 123 | NRU | 12 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | 54 | 123 | TX | SLS-110 | SLS-110 | 54 | IVTDU | In vitro Treatment Duration Unit | HOURS | 55 | 123 | TX | SLS-110 | SLS-110 | 55 | INCBTMP | Incubation Temperature | 37 | 56 | 123 | TX | SLS-110 | SLS-110 | 56 | INCBTMPU | Incubation Temperature Unit | C | 57 | 123 | TX | SLS-110 | SLS-110 | 57 | SWAVENM | Spectrophotometer Wavelength | 540 | 58 | 123 | TX | SLS-110 | SLS-110 | 58 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | 59 | 123 | TX | SLS-110 | SLS-110 | 59 | ATMCO2P | Atmospheric CO2 Percent | 5 | 60 | 123 | TX | SLS-110 | SLS-110 | 60 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | 61 | 123 | TX | SLS-110 | SLS-110 | 61 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | 62 | 123 |
|
1TRTDMIN | Treatment Duration Minimum | 47.5 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 63 |
|
22NRU | 2TRTDTRG | Treatment Duration Target | 48 | EXPTYP | Exposure Type | Air Liquid Interface | 64 |
|
23NRU | 3TRTDMAX | Treatment Duration Maximum | 48.5 | SAMTYP | Sample Type | Liquid | 65 |
|
24NRU | 4TRTDU | Treatment Duration Unit | HOURS | ITVNAM | Intervention Article Name | Sodium Laurel Sulfate | 66 |
|
25NRU | 5INCBTMP | Incubation Temperature | 37 | 26 | 123 | ITVTYPE | Intervention Article Type | POSITIVE CONTROL | 67 | 123 |
|
NRU6INCBTMPU | Incubation Temperature Unit | C
| ITVCONC | Intervention Article Concentration | | 68 |
|
27NRU | 7WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 69 | 123 |
|
28 | 123 | NRU8HUMID | Atmospheric Relative Humidity Percent | 90 | 29 | 123 | NRU | TX | SLS-110 | SLS-110 | 9 | ATMCO2 | Atmospheric CO2 Percent | 5 |
30 | 123 | NRU | TX | SLS-110 | SLS-110 | 10 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
31 | 123 | NRU | TX | SLS-110 | SLS-110 | 11 | EXPTYP | Exposure Type | Air Liquid Interface |
32 | 123 | NRU | TX | SLS-110 | SLS-110 | 12 | SAMTYP | Sample Type | Liquid |
33 | 123 | NRU | TX | SLS-110 | SLS-110 | 13 | INTRVN | Name of the Intervention Article | Sodium Laurel Sulfate |
34 | 123 | NRU | TX | SLS-110 | SLS-110 | 14 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | POSITIVE CONTROL |
35 | 123 | NRU | TX | SLS-110 | SLS-110 | 15 | ITVCONC | intervention concentration | 200 |
36 | 123 | NRU | TX | SLS-110 | SLS-110 | 16 | ITVCONCU | intervention unit | ug/ml |
37 | 123 | NRU | TX | SLS-110 | SLS-110 | 17 | STRAIN | Strain/Substrain | CHO |
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38 | 123 | NRU | TX | SLS-110 | SLS-110 | 18 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
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39 | 123 | NRU | TX | SLS-110 | SLS-110 | 19 | DUREFID | Smoking Regime | Medium Intensity Regimen |
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40 | 123 | NRU | TX | SLS-110 | SLS-110 | 20 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |