- Created by Lou Ann Kramer, last modified on Aug 01, 2022
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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
- 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 |
---|---|---|---|---|---|---|---|---|---|
1 | 123 | ALL | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | ||
11 | 123 | ALL | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | ||
13 | 123 | ALL | TS | 1 | STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods | ||
14 | 123 | ALL | TS | 1 | SNDIGVER | SEND Implementation Guide Version | Tobacco IMPLEMENTATION GUIDE VERSION 1.0 | ||
15 | 123 | ALL | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-03-26 | ||
17 | 123 | ALL | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | ||
18 | 123 | ALL | TS | 1 | SPREFID | Sponsor's Study Reference ID | NOT APPLICABLE | ||
19 | 123 | ALL | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | |
20 | 123 | ALL | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | |
21 | 123 | ALL | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | |
24 | 123 | ALL | 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 | ALL | 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 | ||
34 | 123 | MNT | TS | 1 | ?? | Test System? | TK6 Lymphoblastoid Suspension Cells | ||
35 | 123 | NRU | TS | 1 | ASTD | Assay Standard | NIH Publication No. 07-4519 | ||
36 | 123 | NRU | TS | 1 | ASTDV | Assay Standard Version | 2006-11 | ||
37 | 123 | NRU | TS | 1 | SSTYP | Study Type | |||
38 | 123 | NRU | TS | 1 | SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake | ||
39 | 123 | NRU | TS | 1 | SPECIES | Species | Homo Sapiens | ||
40 | 123 | NRU | TS | 1 | ?? | Test System?? | Normal Human Keratinocyte |
Treatment Duration will be controlled? During CT definition/revies will need to decide appropriate Treatment duration values; If not, what are best example values to show?
Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
---|---|---|---|---|---|---|---|---|---|
1 | 123 | MNT | TX | A1 | METACT | Metabolic Activation | +S9 | ||
2 | 123 | MNT | TX | A1 | TRTDUR | Treatment Duration | Short Term | ||
3 | 123 | MNT | TX | A1 | PRDCONC | Concentration of product | 0 | ||
4 | 123 | MNT | TX | A1 | PRDCONCU | Concentration Unit | ug/ml | ||
5 | 123 | MNT | TX | A1 | Product | Product Name | |||
6 | 123 | MNT | TX | A1 | Smoking Regime | ||||
7 | 123 | MNT | TX | A1 | Smoke Fraction | ||||
123 | MNT | TX | A2 | METACT | Metabolic Activation | +S9 | |||
123 | MNT | TX | A2 | TRTDUR | Treatment Duration | Short Term | |||
123 | MNT | TX | A2 | PRDCONC | Concentration of product | 1250 | |||
123 | MNT | TX | A2 | PRDCONCU | Concentration Unit | ug/ml | |||
123 | MNT | TX | A2 | Product | Product Name | ||||
123 | MNT | TX | A2 | Smoking Regime | |||||
123 | MNT | TX | A2 | Smoke Fraction | |||||
8 | 123 | MNT | TX | B | METACT | Metabolic Activation | -S9 | ||
9 | 123 | MNT | TX | B | TRTDUR | Treatment Duration | Short Term | ||
10 | 123 | MNT | TX | B | TRTDUR | Treatment Duration | Long Term (or 2 parm codes, # and unit) | ||
11 | 123 | MNT | TX | B | PRDCONC | Concentration of product | 0 | ||
12 | 123 | MNT | TX | B | PRDCONCU | Concentration Unit | ug/ml | ||
13 | 123 | MNT | TX | B | Product | Product Name | |||
14 | 123 | MNT | TX | B | Smoking Regime | ||||
15 | 123 | MNT | TX | B | Smoke Fraction | ||||
8 | 123 | MNT | TX | C | METACT | Metabolic Activation | -S9 | ||
9 | 123 | MNT | TX | C | TRTDUR | Treatment Duration | Long Term | ||
10 | 123 | MNT | TX | C | TRTDUR | Treatment Duration | Long Term (or 2 parm codes, # and unit) | ||
11 | 123 | MNT | TX | C | PRDCONC | Concentration of product | 0 | ||
12 | 123 | MNT | TX | C | PRDCONCU | Concentration Unit | ug/ml | ||
13 | 123 | MNT | TX | C | Product | Product Name | |||
14 | 123 | MNT | TX | C | Smoking Regime | ||||
15 | 123 | MNT | TX | C | Smoke Fraction |
BLEO & CPA - positive controls?
Row | STUDYID | ASSAYID | DOMAIN | TXCD | GTSEQ | GTTESTCD | GTTEST | GTCELLEV (cells evaluated) | GTORRES | GTORRESU | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC | GTNOMDY | GTELTM | GTTPTREF |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 123 | MNT | GT | A2 | 1 | RICC | 134 | 15.7 | % | 15.7 | 15.7 | % | 2022-05-25 | ||||
2 | 123 | MNT | GT | A2 | 2 | RCC | 134 | 13.0 | % | 13.0 | 13.0 | % | 2022-05-25 | ||||
3 | 123 | MNT | GT | A2 | 3 | RPD | 134 | 7.9 | % | 7.9 | 7.9 | % | 2022-05-25 | ||||
4 | 123 | MNT | GT | A2 | 4 | MNCELLS | Micronucleated Cells | 3266 | 20 | Cells | 20 | 20 | Cells | 2022-05-25 | |||
5 | 123 | MNT | GT | A2 | 5 | MNCELLS | Micronucleated Cells | 2190 | 17 | Cells | 17 | 17 | Cells | 2022-05-25 | |||
6 | 123 | MNT | GT | A2 | 6 | MNCELLS | Micronucleated Cells | 2758 | 13 | Cells | 13 | 13 | Cells | 2022-05-25 | |||
7 | 123 | MNT | GT | A2 | 7 | MNCELLS | Micronucleated Cells | 2714 | 21 | Cells | 21 | 21 | Cells | 2022-05-25 | |||
8 | 123 | MNT | GT | A2 | 8 | AVGREL | Average Relative MN Frequency | 0.66 | % | 0.66 | 0.66 | % | 2022-05-25 | ||||
9 | 123 | MNT | GT | A1 | 1 | RICC | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | ||||
10 | 123 | MNT | GT | A1 | 2 | RCC | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | ||||
11 | 123 | MNT | GT | A1 | 3 | RPD | 154 | 0 | % | 0 | 0 | % | 2022-05-25 | ||||
12 | 123 | MNT | GT | A1 | 4 | MNCELLS | Micronucleated Cells | 3266 | 15 | Cells | 15 | 15 | Cells | 2022-05-25 | |||
13 | 123 | MNT | GT | A1 | 5 | MNCELLS | Micronucleated Cells | 2190 | 13 | Cells | 13 | 13 | Cells | 2022-05-25 | |||
14 | 123 | MNT | GT | A1 | 6 | MNCELLS | Micronucleated Cells | 2758 | 17 | Cells | 17 | 17 | Cells | 2022-05-25 | |||
15 | 123 | MNT | GT | A1 | 7 | MNCELLS | Micronucleated Cells | 2714 | 12 | Cells | 12 | 12 | Cells | 2022-05-25 | |||
16 | 123 | MNT | GT | A1 | 8 | AVGREL | Average Relative MN Frequency | 0.57 | % | 0.57 | 0.57 | % | 2022-05-25 | ||||
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??
(also see Gentox notes on how to approach modeling, to apply that here?)
(Do we need this? a single element (treatment)?)
Row | STUDYID | ASSAYID | DOMAIN | ETCD | ELEMENT |
---|
(Do we need this? one arm for each trial set?)
Row | STUDYID | ASSAYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT |
---|
Row | STUDYID | DOMAIN | ENID (Entity ID) | RICC | RCC | RPD | Sum of cell ev. | Cells with MN | SMKFID (Smoke Fraction) | REPLCTID (Replicate Number) | PLATEID (Plate ID) | COLID (Column number) | ROWID (Row number) | SETCD (Set Code, TX) | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFCSTDTC | RFCENDTC | ARMCD |
---|
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