- 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?
Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
---|
1 | 123 | NRU | TX | 1-2-B(plate-col-row in the 96-well plate) | CSC- | 1050(through SLS-200) | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 | 2 | 123 | NRU | TX | 1-2-B | CSC- | 1050 | 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- | 1050 | 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- | 1050 | 5 | ITVCONC | intervention concentration | 50 |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 6 | ITVCONCU | intervention unit | ug/ml |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
101050 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 10 | RUN | Assay run number | 1 |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 11 | SMPLID | Sample ID | 030001 |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 13 | REPNUM | Replicate Number | 1 |
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 14 | TRTDMIN | Treatment Duration Min | 47.5 |
---|
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 15 | TRTDTRG | Treatment Duration Target | 48 |
---|
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 16 | TRTDMAX | Treatment Duration Max | 48.5 |
---|
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 17 | TRTDU | Treatment Duration Unit | HOURS |
---|
| 123 | NRU | TX | 1-2-B | CSC- |
---|
1050 | 18 | INCBTMP | Incubation Temperature | 37 |
---|
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 19 | INCBTMPU | Incubation Temperature Unit | C
|
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 20 | MEDIA | Composition of Media | Sartorius HEK293 |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 24 | EXPTYP | Exposure Type | Air Liquid Interface |
| 123 | NRU | TX | 1-2-B | CSC- | 1050 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 1 | PLATENUM. (e.g., 1 or 2) | 1 | 1 |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 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- | 1BC | CSC-10 | 3 | INTRVN | name of the intervention article | Cigarette Smoke Condensate |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 4 | ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 5 | ITVCONC | intervention concentration | 10 |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 6 | ITVCONCU | intervention unit | ug/ml |
| 123 | NRU | TX | 1- |
---|
1B1BC | CSC-10 | 8 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 9 | DUREFID | Smoking Regime | Medium Intensity Regimen |
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 10 | RUN | Assay run number | 1 |
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 11 | SMPLID | Sample ID | 030001 |
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 12 | SMKEXSYS | Smoke Exposure System | Cambridge filter pad, eluted in DMSO |
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 13 | REPNUM | Replicate Number | 1 |
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 14 | TRTDMIN | Treatment Duration Min | 47.5 |
---|
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 15 | TRTDTRG | Treatment Duration Target | 48 |
---|
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 16 | TRTDMAX | Treatment Duration Max | 48.5 |
---|
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 17 | TRTDU | Treatment Duration Unit | HOURS |
---|
| 123 | NRU | TX | 1- |
---|
1BC | CSC-10 | 18 | INCBTMP | Incubation Temperature | 37 |
---|
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 19 | INCBTMPU | Incubation Temperature Unit | C
|
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 20 | MEDIA | Composition of Media | Sartorius HEK293 |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 21 | HUMID | Atmospheric Relative Humidity Percent | 90 |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 22 | ATMCO2 | Atmospheric CO2 Percent | 5 |
| 123 | NRU | TX | 1- | 1BC | CSC-10 | 23 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | ... |
|
|
| ... |
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|
| 123 | NRU | TX | 1-10-H | SLS-10 |
| PLATENUM | Plate number | 1 |
| 123 | NRU | TX | 1-10-H | SLS-10 |
| WELLNUM | Number representing the location of the well in the 96-well plate | 10-H |
| 123 | NRU | TX | 1-10-H | SLS-10 |
| INTRVN | name of the intervention article | sodium laurel sulfate |
| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVTYPE | type of intervention article | POSITIVE CONTROL |
| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVCONC | intervention concentration | 200 |
| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVCONCU | intervention unit | ug/ml |
| 123 | NRU | TX | 1-10-H | SLS-10 | 24 | EXPTYP | Exposure Type | Air Liquid Interface |
| 123 | NRU | TX | 1-10-H | SLS-10 | 25 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | ... |
|
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| ... |
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|
| 123 | NRU | TX | 2-10-H | SLS-10 |
| PLATENUM | Plate number | 2 |
| 123 | NRU | TX | 2-10-H | SLS-10 |
| WELLNUM | Number representing the location of the well in the 96-well plate | 10-H |
| 123 | NRU | TX | 2-10-H | SLS-10 |
| INTRVN | name of the intervention article | sodium laurel sulfate |
| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVTYPE | type of intervention article | POSITIVE CONTROL |
| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVCONC | intervention concentration | 200 |
| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVCONCU | intervention unit | ug/ml | ... |
|
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| ... |
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