This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
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| Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | MNT | TX | A | METACT | Metabolic Activation | +S9 | MNT | A | TRTDUR | Treatment Duration | Short Term | MNT | A | PRDCONC | Concentration of product | 1250 | A | PRDCONCU | Concentration Unit | ug/ml | A | Product | Product Name | A | Smoking Regime | A | Smoke Fraction | METACT | Metabolic Activation | -S9 | TRTDUR | Treatment Duration | Short Term | TRTDUR | Treatment Duration | Long Term (or 2 parm codes, # and unit) | PRDCONC | Concentration of product | 0 | PRDCONCU | Concentration Unit | ug/ml | Product | Product Name | Smoking Regime | Smoke Fraction | | Expand |
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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
Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 123 | ALL | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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| 11 | 123 | ALL | TS | 1 |
| STSTDTC | Study Start Date | 2007-12-30 |
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| 13 | 123 | ALL | TS | 1 |
| STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods |
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| 14 | 123 | ALL | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | Tobacco IMPLEMENTATION GUIDE VERSION 1.0 |
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| 15 | 123 | ALL | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 |
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| 17 | 123 | ALL | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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| 18 | 123 | ALL | TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
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| 19 | 123 | ALL | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
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| 20 | 123 | ALL | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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| 21 | 123 | ALL | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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| 24 | 123 | ALL | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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| 25 | 123 |
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| TRT | Investigational Therapy or Treatment | Drug A |
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| 26 | 123 |
| TS | 1 | 2 | TRTV | Treatment Vehicle | Saline |
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| 27 | 123 |
| TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} |
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| 28 | 123 | ALL | TS | 1 |
| GLPFL | GLP Flag | Y |
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| 29 | 123 | MNT | TS | 1 |
| ASTD | Assay Standard | OECD Test No. 487 |
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| 30 | 123 | MNT | TS | 1 |
| ASTDV | Assay Standard Version | 2016-07-29 |
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| 31 | 123 | MNT | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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| 32 | 123 | MNT | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Micronucleus |
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| 33 | 123 | MNT | TS | 1 |
| SPECIES | Species | Homo Sapiens |
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| 34 | 123 | MNT | TS | 1 |
| ?? | Test System? | TK6 Lymphoblastoid Suspension Cells |
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| 35 | 123 | NRU | TS | 1 |
| ASTD | Assay Standard | NIH Publication No. 07-4519 |
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| 36 | 123 | NRU | TS | 1 |
| ASTDV | Assay Standard Version | 2006-11 |
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| 37 | 123 | NRU | TS | 1 |
| SSTYP | Study Type |
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| 38 | 123 | NRU | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
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| 39 | 123 | NRU | TS | 1 |
| SPECIES | Species | Homo Sapiens |
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40 | 123 | NRU | TS | 1 |
| ?? | Test System?? | Normal Human Keratinocyte |
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| Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | MNT | TX | A |
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| METACT | Metabolic Activation | +S9 |
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| TRTDUR | Treatment Duration | Short Term |
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| PRDCONC | Concentration of product | 1250 |
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| PRDCONCU | Concentration Unit | ug/ml |
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| Product | Product Name |
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| Smoking Regime |
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| Smoke Fraction |
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| METACT | Metabolic Activation | -S9 |
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| TRTDUR | Treatment Duration | Short Term |
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| TRTDUR | Treatment Duration | Long Term (or 2 parm codes, # and unit) |
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| PRDCONC | Concentration of product | 0 |
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| PRDCONCU | Concentration Unit | ug/ml |
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| Product | Product Name |
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| Smoking Regime |
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| Smoke Fraction |
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| title | gt.xpt (similar to LB) |
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| Row | STUDYID | ASSAYID | DOMAIN | TXCD | GTSEQ | GTTESTCD | GTTEST | GTCELLEV
(cells evaluated) | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC | GTNOMDY | GTELTM | GTTPTREF |
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| 1 | 123 | MNT | GT | A | 1 | RICC |
| 134 | 15.7 | % | 15.7 | 15.7 | % | 2022-05-25 |
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| | 2 | 123 | MNT | GT | A | 2 | RCC |
| 134 | 13.0 | % | 13.0 | 13.0 | % | 2022-05-25 |
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| | 3 | 123 | MNT | GT | A | 3 | RPD |
| 134 | 7.9 | % | 7.9 | 7.9 | % | 2022-05-25 |
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| | 4 | 123 | MNT | GT | A | 4 | MNCELLS | Micronucleated Cells | 3266 | 20 | Cells | 20 | 20 | Cells | 2022-05-25 |
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| | 5 | 123 | MNT | GT | A | 5 | MNCELLS | Micronucleated Cells | 2190 | 17 | Cells | 17 | 17 | Cells | 2022-05-25 |
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| | 6 | 123 | MNT | GT | A | 6 | MNCELLS | Micronucleated Cells | 7258 | 13 | Cells | 13 | 13 | Cells | 2022-05-25 |
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| | 7 | 123 | MNT | GT | A | 7 | AVGREL | Average Relative MN Frequency |
| 0.66 | % | 0.66 | 0.66 | % | 2022-05-25 |
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| | 8 | 123 | NRU | GT |
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