TRIAL ELEMENTS | Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
|---|
|
|
| TE | TREATMT | Treatment |
Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc. https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null One study (Original sample of TK6 cells); (6 rows in GT) Assay (MNT) (ran on 10 tobacco products)
3 assay/test conditions;
Treatment duration (2: ST, LT);
Presence of metabolic activation (2: presence, type) Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
CytoTox % (3 different percentages from testing 1 portion of the original sample)
4 MN counts conducted (on 4 different portions of original sample?) EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes Cytotox: RICC, RIC, RPD, #cells Assumption: ASSAYID value of ALL means it applies to all assays in the study Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
|---|
| 1 | 123 |
| TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
|
|---|
| 11 | 123 |
| TS | 1 |
| STSTDTC | Study Start Date | 2007-12-30 |
|
|---|
| 13 | 123 |
| TS | 1 |
| STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods |
|
|---|
| 14 | 123 |
| TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | Tobacco IMPLEMENTATION GUIDE VERSION 1.0 |
|
|---|
| 15 | 123 |
| TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 |
|
|---|
| 17 | 123 |
| TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
|
|---|
| 18 | 123 |
| TS | 1 |
| SPREFID | Sponsor's Study Reference ID |
| NOT APPLICABLE |
|---|
| 19 | 123 |
| TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
|
|---|
| 20 | 123 |
| TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
|
|---|
| 21 | 123 |
| TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
|
|---|
| 24 | 123 |
| TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
|
|---|
| 25 | 123 |
| TS | 1 |
| TRT | Investigational Therapy or Treatment | Drug A |
|
|---|
| 26 | 123 |
| TS | 1 | 2 | TRTV | Treatment Vehicle | Saline |
|
|---|
| 27 | 123 |
| TS | 1 | 2 | TRTVDESC | Treatment Vehicle Structured Description | 100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W} |
|
|---|
| 28 | 123 |
| TS | 1 |
| GLPFL | GLP Flag | Y |
|
|---|
| 29 | 123 | MNT | TS | 1 |
| ASTD | Assay Standard | OECD Test No. 487 |
|
|---|
| 30 | 123 | MNT | TS | 1 |
| ASTDV | Assay Standard Version | 2016-07-29 |
|
|---|
| 31 | 123 | MNT | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
|
|---|
| 32 | 123 | MNT | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Micronucleus |
|
|---|
| 33 | 123 | MNT | TS | 1 |
| SPECIES | Species | Homo Sapiens |
|
|---|
| 123 | MNT | TS | 1 |
| ?? | Test System? | TK6 Lymphoblastoid Suspension Cells |
|
|---|
| 123 | NRU | TS | 1 |
| ASTD | Assay Standard | NIH Publication No. 07-4519 |
|
|---|
| 123 | NRU | TS | 1 |
| ASTDV | Assay Standard Version | 2006-11 |
|
|---|
| 123 | NRU | TS | 1 |
| SSTYP | Study Type |
|
|
|---|
| 123 | NRU | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
|
|---|
| 123 | NRU | TS | 1 |
| SPECIES | Species | Homo Sapiens |
|
|---|
| 123 | NRU | TS | 1 |
| ?? | Test System?? | Normal Human Keratinocyte |
|
|---|
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
|---|
| 1 | 123 | 1MNT | TX | A |
|
| METACT | Metabolic Activation | +S9 |
|
| 1MNT |
| A |
|
| TRTDUR | Treatment Duration | Short Term |
|
| 1MNT |
| A |
|
| PRDCONC | Concentration of product | 1250 |
|
|
|
| 1 | A |
|
| PRDCONCU | Concentration Unit | ug/ml |
|
|
|
| 1 | A | 1 |
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| A |
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| METACT | Metabolic Activation | -S9 |
|
|
|
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|
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| TRTDUR | Treatment Duration | Short Term |
|
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|
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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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