This example shows trial design and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.
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Neutral Red Uptake Assay for Mainstream Tobacco Smoke: The neutral red uptake assay provides a quantitative estimation of the number of viable cells in a culture. It is one of the most used cytotoxicity tests with many biomedical and environmental applications. It is based on the ability of viable cells to incorporate and bind the supravital dye neutral red in the lysosomes. Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)Red Font = has/should have CTGrey-shaded cells = ignore for now (until we model other tests)Because a study contains one or more Assays, we have both: STUDYID and ASSAYID |
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title | ts.xpt (trial summary, study level parameters) |
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- Assumption: Study can have more than one assay type
- Assumption: ASSAYID value of ALL means it applies to all assays in the study
- Replaced the ASSAYID values of MNT with MNvit (term used in OECD #487) - is this better? This is not a controlled term so we can use anything but what we use in our IG examples are often used in industry implementations so we should use realistic and best practice values as much as possible.
- BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
- Where is TK6 cell type? is this test system (see below)
Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | NRU | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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2 | 123 | NRU | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
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3 | 123 | NRU | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
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4 | 123 | NRU | TS | 1 |
| STITLE | Study Title | Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake |
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5 | 123 | NRU | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
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6 | 123 | NRU | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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7 | 123 | NRU | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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8 | 123 | NRU | TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
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9 | 123 | NRU | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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10 | 123 | NRU | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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11 | 123 | NRU | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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... | 123 | NRU | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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| 123 | NRU | TS | 1 |
| GLPFL | GLP Flag | Y |
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| 123 | NRU | TS | 1 |
| ASTD | Assay Standard | NIH Publication No. 07-4519 |
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| 123 | NRU | TS | 1 |
| ASTDV | Assay Standard Version | 2006-11 |
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| 123 | NRU | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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| 123 | NRU | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
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| 123 | NRU | TS | 1 |
| SPECIES | Species | Salmonella enterica |
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| 123 | NRU | TS | 1 |
| STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| 123 | NRU | TS | 1 |
| ?? | Test System?? | Normal Human Keratinocyte |
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| 123 | NRU | TS | 1 |
| REGIME | Smoking Regime | Traditional combustible |
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| 123 | NRU | TS | 1 |
| RUNPRT | run-port number?? (always same for whole assay?) | 1-1 |
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| 123 | NRU | TS | 1 |
| SMPLID | Sample ID | 030001 |
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| 123 | NRU | TS | 1 |
| SMKFRC | Smoke Fraction | A |
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| 123 |
| TS | 1 |
| REPNUM | Replicate Number | 1 |
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