This example shows trial design and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.
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Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)- red font - indicates potential for CT code lists
- green font - links to other domains
- purple font - remaining questions to resolve
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- 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.)
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL | Definitions |
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| 1 | 123 | NRU | TX | 1-1-A(plate-col-row in the 96-well plate) | CSC-10(through SLS-200) |
| PLATENUM. (e.g., 1 or 2) | 1 | 1 |
| | 2 | 123 | NRU | TX | 1-1-A | CSC-10 |
| WELLNUM (e.g., 1-A through 10-H) | Number representing the location of the well in the 96-well plate | 1-A |
| | 3 | 123 | NRU | TX | 1-1-A | CSC-10 |
| INTRVN | name of the intervention article | Cigarette Smoke Condensate |
| | 4 | 123 | NRU | TX | 1-1-A | CSC-10 |
| ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT |
| | 5 | 123 | NRU | TX | 1-1-A | CSC-10 |
| ITVCONC | intervention concentration | 10 |
| | 6 | 123 | NRU | TX | 1-1-A | CSC-10 |
| ITVCONCU | intervention unit | ug/ml |
| | 7 | 123 | NRU | TX | 1-1-A | CSC-10 |
| STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| 8 | 123 | NRU | TX | 1-1-A | CSC-10 |
| REGIME | Smoking Regime | Traditional combustible |
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| 9 | 123 | NRU | TX | 1-1-A | CSC-10 |
| RUN | Assay run number | 1 |
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10 | 123 | NRU | TX | 1-1-A | CSC-10 |
| PORT | Port ID | 1 |
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| 11 | 123 | NRU | TX | 1-1-A | CSC-10 |
| SMPLID | Sample ID | 030001 |
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| 12 | 123 | NRU | TX | 1-1-A | CSC-10 |
| SMKFRC | Smoke Fraction | A |
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| 13 | 123 | NRU | TX | 1-1-A | CSC-10 |
| REPNUM | Replicate Number | 1 |
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| 1 | 123 | NRU | TX | 1-1-B | CSC-10 |
| PLATENUM. (e.g., 1 or 2) | 1 | 1 |
| | 2 | 123 | NRU | TX | 1-1-B | CSC-10 |
| WELLNUM (e.g., 1-A through 10-H) | Number representing the location of the well in the 96-well plate | 1-A |
| | 3 | 123 | NRU | TX | 1-1-B | CSC-10 |
| INTRVN | name of the intervention article | Cigarette Smoke Condensate |
| | 4 | 123 | NRU | TX | 1-1-B | CSC-10 |
| ITVTYPE(CT e.g, Product, positive control, negative control) | type of intervention article | PRODUCT |
| | 5 | 123 | NRU | TX | 1-1-B | CSC-10 |
| ITVCONC | intervention concentration | 10 |
| | 6 | 123 | NRU | TX | 1-1-B | CSC-10 |
| ITVCONCU | intervention unit | ug/ml |
| | 7 | 123 | NRU | TX | 1-1-B | CSC-10 |
| STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| 8 | 123 | NRU | TX | 1-1-B | CSC-10 |
| REGIME | Smoking Regime | Traditional combustible |
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| 9 | 123 | NRU | TX | 1-1-B | CSC-10 |
| RUN (Test Result, use to analyze for biases, group of replicates over time frame and lab condition) | Assay run number | 1 | Identified at result level, |
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10 | 123 | NRU | TX | 1-1-B | CSC-10 |
| PORT | Port ID | 1 |
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| 11 | 123 | NRU | TX | 1-1-B | CSC-10 |
| SMPLID | Sample ID | 030001 |
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| 12 | 123 | NRU | TX | 1-1-B | CSC-10 |
| SMKFRC | Smoke Fraction | A |
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| 13 | 123 | NRU | TX | 1-1-B | CSC-10 |
| REPNUM (Replicated independent separate samples prepared and run the same vs. duplicates across wells, running the same replicate across many wells) | Replicate Number | 1 |
Trial = Sample preps (creating test material) vs. Replicates = different plates Col/Row = testing of an individual sample multiple times |
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| - Preparing test material ( different materials in different flasks,
- Applying test material to plate/well
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| | 14 | 123 | NRU | TX | 1-1-B | CSC-10 |
| ITVCONC | intervention concentration | 10 |
| | 15 | 123 | NRU | TX | 1-1-B | CSC-10 |
| ITVCONCU | intervention unit | ug/ml |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| PLATENUM | Plate number | 1 |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| WELLNUM | Number representing the location of the well in the 96-well plate | 10-H |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| INTRVN | name of the intervention article | sodium laurel sulfate |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVTYPE | type of intervention article | POSITIVE CONTROL |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVCONC | intervention concentration | 200 |
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| 123 | NRU | TX | 1-10-H | SLS-10 |
| ITVCONCU | intervention unit | ug/ml |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| PLATENUM | Plate number | 2 |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| WELLNUM | Number representing the location of the well in the 96-well plate | 10-H |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| INTRVN | name of the intervention article | sodium laurel sulfate |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVTYPE | type of intervention article | POSITIVE CONTROL |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVCONC | intervention concentration | 200 |
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| 123 | NRU | TX | 2-10-H | SLS-10 |
| ITVCONCU | intervention unit | ug/ml |
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