This example shows a report table, trial design
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-78 |
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, and results data for the in vitro
Neutral Red Uptake Cytotoxicity Assay| Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-333 |
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in example study 123.neutral red uptake (NRU) cytotoxicity assay in example study 123.| Expand |
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| title | Sample from Report Table |
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The following shows example data |
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| title | Sample from Report Table |
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Image Removed The following shows example data for study 123 in a report table. This report includes summary statistics (i.e.g. Average, Standard Deviation, Coeff. Var., average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. The grey cells in In the table below, the light grey shading for plate 1 are cells values from wells that do not contain the NHK cells. the NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset. For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use.
Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data |
Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data) |
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| Sample ID | Smoke Regime | Replicate Number | Plate Number |
Well Number |
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| Relative Assay Plate Absorbance Readings |
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| Cigarette Smoke Condensate (µg/mL) | SLS (µg/mL) |
| EC50 (µg/ml) | Well Column: | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
| Well
Row: | 0 | 10 | 50 | 75 | 100 | 120 | 140 | 160 | 200 | 110 | 200 | 0 |
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| 030001 | Medium | 1 | 1 |
1A | 0.046*
| 0.046* | 0.039* | 0.012* | 0.030* | 0.003* | 0.057* | 0.032* | 0.003* | 0.050* | 0.044* | 0.040* |
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| 030001 | Medium | 1 | 1 |
2B | 0.048* | 107 | 77.7 | 65.7 | 30.2 | 15.6 | 9.79 | 5.41 | 2.49 | 8.09 | 0.791 | 0.014* |
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| 030001 | Medium | 1 | 1 |
3C | 0.005* | 98.6 | 77.4 | 57.7 | 35.8 | 8.09 | 7.36 | 3.22 | 0.791 | 6.38 | 0.061 | 0.050* |
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| 030001 | Medium | 1 | 1 |
4D | 0.049* | 94.9 | 81.5 | 38.2 | 31.2 | 7.60 | 5.17 | 3.22 | 0.791 | 5.17 | 0.304 | 0.017* |
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| 030001 | Medium | 1 | 1 |
5E | 0.047* | 111 | 78.1 | 64.5 | 32.9 | 8.82 | 5.90 | 2.74 | 1.28 | 10.3 | 0.547 | 0.011* |
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| 030001 | Medium | 1 | 1 |
6F | 0.032* | 96.6 | 76.2 | 48.0 | 26.8 | 7.84 | 4.20 | 2.74 | 1.52 | 8.09 | 4.93 | 0.022* |
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| 030001 | Medium | 1 | 1 |
7G | 0.044* | 105 | 77.9 | 58.2 | 28.3 | 8.09 | 4.68 | 1.76 | 0.547 | 8.57 | 1.76 | 0.056* |
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| 030001 | Medium | 1 | 1 |
8H | 0.056* | 0.013* | 0.040* | 0.008* | 0.013* | 0.002* | 0.029* | 0.018* | 0.006* | 0.016* | 0.024* | 0.046* |
| Average |
| 101 | 78.2 | 54.5 | 29.9 | 9.70 | 6.17 | 3.37 | 1.19 | 8.94 | 1.22 |
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| Std. Dev. |
| 6 | 2.9 | 9.4 | 3.6 | 2.95 | 2.19 | 1.12 | 0.72 | 2.72 | 1.58 |
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| Coeff. Var. |
| 5.8 | 3.6 | 17.2 | 11.9 | 30.4 | 35.5 | 33.1 | 61.0 | 30.5 | 129.9 |
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| *media without cells |
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| 030001 | Medium | 1 | 2 |
1A |
| 93.4 | 74.0 | 56.0 | 35.1 | 11.8 | 8.70 | 5.10 | 1.98 | 5.34 | 1.02 |
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| 030001 | Medium | 1 | 2 |
2B |
| 102 | 75.2 | 53.3 | 35.1 | 11.8 | 7.74 | 5.58 | 3.66 | 5.34 | 1.02 |
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| 030001 | Medium | 1 | 2 |
3C |
| 107 | 79.0 | 55.0 | 26.5 | 10.1 | 6.06 | 3.66 | 1.74 | 7.02 | 0.780 |
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| 030001 | Medium | 1 | 2 |
4D |
| 104 | 80.2 | 55.3 | 29.8 | 8.94 | 3.90 | 3.66 | 1.50 | 6.30 | 0.780 |
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| 030001 | Medium | 1 | 2 |
5E |
| 101 | 75.7 | 54.1 | 26.7 | 4.86 | 4.38 | 1.26 | 1.02 | 6.30 | 1.02 |
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| 030001 | Medium | 1 | 2 |
6F |
| 110 | 85.7 | 67.7 | 26.0 | 5.34 | 4.62 | 3.42 | 1.50 | 6.30 | 0.540 |
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| 030001 | Medium | 1 | 2 |
7G |
| 104 | 77.8 | 64.9 | 27.7 | 8.22 | 3.18 | 2.46 | 1.02 | 6.30 | 0.780 |
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| 030001 | Medium | 1 | 2 |
8H |
| 103 | 71.6 | 58.9 | 25.5 | 9.42 | 4.14 | 3.90 | 1.26 | 4.38 | 0.780 |
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| Average |
| 103 | 77.4 | 58.1 | 29.0 | 8.82 | 5.34 | 3.63 | 1.71 | 5.91 | 0.840 |
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| Std. Dev. |
| 5 | 4.4 | 5.3 | 4.0 | 2.63 | 1.97 | 1.37 | 0.86 | 0.83 | 0.170 |
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| Coeff. Var. |
| 4.6 | 5.6 | 9.2 | 13.6 | 29.8 | 36.9 | 37.6 | 50.0 | 14.1 | 20.2 |
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| EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model). |
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| 123 |
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| Rows 1-2: | Show | two | 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP | Types | types apply for this example study. | | Row | 8| 3: | Shows that | the sponsor's | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-356 |
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| this study was conducted as a GLP study. | | Rows 4-5: | Show the study start date and study title. | | Rows 6-7: | Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study. | | Row 8: | Shows the applicant's organization. | | Row 9: | Shows that the applicant's study reference ID is not applicable. | | Rows | 9| 10- | 12| 13: | Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The | Study Director | study director is associated with the | Test Facility| test facility. | | Rows 14-16: | Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). | | Shows the study type for this study. | | Shows that this study includes a Neutral Red Uptake Assay. | | Rows 19-20: | Show that the species is human and the cell line is NHK in this study. |
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| Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 123 |
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Row | STUDYID | GNTXAID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | NRU | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
| | 2 | 123 |
NRU | | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
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NRU | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
4NRU | | TS | 1 |
| STITLE | Study Title | Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay |
5NRU | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
6NRU | | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
7NRUSSPONSORSponsor Organization Sponsor 8NRUSPREFIDSponsor | Applicant Study Reference ID |
| NOT APPLICABLE |
9NRU | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Test Lab Name |
10NRU | | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
11NRU | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
12NRU | | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
13NRUGLPFLGLP Flag | Y | 14 | 123 | NRU | TS | 1 | ASTD | Assay Standard | NIH | TSTGDNAM | Testing Guideline Name |
| Publication No. 07-4519 |
| | 15 | 123 |
NRUASTDVAssay Standard Version | | TSTGDORG | Testing Guideline Organization | NIH |
2006-11 | TS | 1 | 4 | TSTGDVER | Testing Guideline Version | 2006-11 |
| | 17 | 123 |
NRU | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
17NRUSSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
| GNTXAID | Genetic Toxicology Assay Identifier | NRU |
| | 19 | 123 |
18 | 123 | NRUHuman19NRU |
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| Rows 1-12: | Show the test conditions for the |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-279 |
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| Rows 1-12: | Show the test conditions for the set with a short name or SETCD value of ALLNRU. The sponsor applicant chose this value to represent test conditions for the entire assay. | | Rows 13-2031: | Show the test conditions for the set with a short name or SETCD value of CSC-50b. The sponsor applicant chose this value to represent plate number 1, well number 1row A, well column 3, with a concentration of 50µg/mLof Cigarette Smoke Condensate cigarette smoke condensate as shown in the report table for study 123. | Row 20: | Shows the The value for Cell Line , (CELLLN, ) is NOT APPLICABLE not applicable because the well is a media-only well, having no NHK cells. | Rows 2132-2850: | Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, with a , well rows A-H, well column 3. These all have the concentration of 50µg/mLof Cigarette Smoke Condensate cigarette smoke condensate as shown in the report table for study 123. | | Rows 2951-3669: | Show the test conditions for the set with a short name or SETCD value of SLS-110. The sponsor applicant chose this value to represent both wells numbered 7 in plate number 1, well rows B-G, well column 10, and plate number 2, with a concentration of 110µg/mLof Sodium Laurel Sulfate as shown in the report table for study 123.well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123. |
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| Dataset2 |
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| Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | NRU | TX | ALL | ALL_ASSAY | 1 | TRTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 2 | 123 | NRU | TX | ALL | ALL_ASSAY | | TRTDTRG | In vitro Treatment Duration Target | 48 |
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| 3 | 123 | NRU | TX | ALL | ALL_ASSAY | 3 | TRTDMAX | In vitro Treatment Duration Maximum | 48.5 |
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| 4 | 123 | NRU | TX | ALL | ALL_ASSAY | 4 | TRTDU | In vitro Treatment Duration Unit | HOURS |
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| 5 | 123 | NRU | TX | ALL | ALL_ASSAY | 5 | INCBTMP | Incubation Temperature | 37 |
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| 6 | 123 | NRU | TX | ALL | ALL_ASSAY | 6 | INCBTMPU | Incubation Temperature Unit | C | | 7 | 123 | NRU | TX | ALL | ALL_ASSAY | 7 | WAVELGTH | Spectrophotometer wavelength in nanometers | 540 | | 8 | 123 | NRU | TX | ALL | ALL_ASSAY | 8 | HUMID | Atmospheric Relative Humidity Percent | 90 | | 9 | 123 | NRU | TX | ALL | ALL_ASSAY | 9 | ATMCO2 | Atmospheric CO2 Percent | 5 | | 10 | 123 | NRU | TX | ALL | ALL_ASSAY | 10 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k | | 11 | 123 | NRU | TX | ALL | ALL_ASSAY | 11 | DUREFID | Smoking Regime | Medium Intensity Regimen | | 12 | 123 | NRU | TX | ALL | ALL_ASSAY | 12 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 13 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 13 | PSETCD | Parent Set Code | ALL | | 14 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 14 | EXPTYP | Exposure Type | Air Liquid Interface | | 15 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 15 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 16 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 16 | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 17 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 17 | ITVTYPE | Type of intervention article | PRODUCT | | 18 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 18 | ITVCONC | Concentration of intervention article | 50 | | 19 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 19 | ITVCONCU | | ug/ml |
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| 20 | 123 | NRU | TX | CSC-50b | CSC-50-blank | 20 | CELLLN | Cell Line | NOT APPLICABLE | | 21 | 123 | NRU | TX | CSC-50 | CSC-50 | 21 | PSETCD | Parent Set Code | ALL | | 22 | 123 | NRU | TX | CSC-50 | CSC-50 | 22 | EXPTYP | Exposure Type | Air Liquid Interface | | 23 | 123 | NRU | TX | CSC-50 | CSC-50 | 23 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 24 | 123 | NRU | TX | CSC-50 | CSC-50 | 24 | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 25 | 123 | NRU | TX | CSC-50 | CSC-50 | 25 | ITVTYPE | Type of intervention article | PRODUCT | | 26 | 123 | NRU | TX | CSC-50 | CSC-50 | 26 | ITVCONC | Concentration of intervention article | 50 |
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| 27 | 123 | NRU | TX | CSC-50 | CSC-50 | 27 | ITVCONCU | Concentration Unit | ug/ml | | 28 | 123 | NRU | TX | CSC-50 | CSC-50 | 28 | CELLLN | Cell Line | NHK | 29 | 123 | NRU | | ROW | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | TX | NRU | NRU_ASSAY | 1 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 2 | 123 | TX | NRU | NRU_ASSAY | 2 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 3 | 123 | TX | NRU | NRU_ASSAY | 3 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 4 | 123 | TX | NRU | NRU_ASSAY | 4 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 5 | 123 | TX | NRU | NRU_ASSAY | 5 | INCBTMP | Incubation Temperature | 37 | | 6 | 123 | TX | NRU | NRU_ASSAY | 6 | INCBTMPU | Incubation Temperature Unit | C | | 7 | 123 | TX | NRU | NRU_ASSAY | 7 | SWAVENM | Spectrophotometer Wavelength | 540 | | 8 | 123 | TX | NRU | NRU_ASSAY | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 9 | 123 | TX | NRU | NRU_ASSAY | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 10 | 123 | TX | NRU | NRU_ASSAY | 10 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 11 | 123 | TX | NRU | NRU_ASSAY | 11 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 12 | 123 | TX | NRU | NRU_ASSAY | 12 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 13 | 123 | TX | CSC-50b | CSC-50-blank | 13 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 14 | 123 | TX | CSC-50b | CSC-50-blank | 14 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 15 | 123 | TX | CSC-50b | CSC-50-blank | 15 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 16 | 123 | TX | CSC-50b | CSC-50-blank | 16 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 17 | 123 | TX | CSC-50b | CSC-50-blank | 17 | INCBTMP | Incubation Temperature | 37 | | 18 | 123 | TX | CSC-50b | CSC-50-blank | 18 | INCBTMPU | Incubation Temperature Unit | C | | 19 | 123 | TX | CSC-50b | CSC-50-blank | 19 | SWAVENM | Spectrophotometer Wavelength | 540 | | 20 | 123 | TX | CSC-50b | CSC-50-blank | 20 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 21 | 123 | TX | CSC-50b | CSC-50-blank | 21 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 22 | 123 | TX | CSC-50b | CSC-50-blank | 22 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 23 | 123 | TX | CSC-50b | CSC-50-blank | 23 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 24 | 123 | TX | CSC-50b | CSC-50-blank | 24 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 25 | 123 | TX | CSC-50b | CSC-50-blank | 25 | EXPTYP | Exposure Type | Air Liquid Interface | | 26 | 123 | TX | CSC-50b | CSC-50-blank | 26 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 27 | 123 | TX | CSC-50b | CSC-50-blank | 27 | ITVNAM | Name of the Intervention Article | Tobacco ProdA | | 28 | 123 | TX | CSC-50b | CSC-50-blank | 28 | ITVTYPE | Intervention Article Type | PRODUCT | | 29 | 123 | TX | CSC-50b | CSC-50-blank | 29 | ITVCONC | Intervention Article Concentration | 50 | | 30 | 123 | TX | CSC-50b | CSC-50-blank | 30 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 31 | 123 | TX | CSC-50b | CSC-50-blank | 31 | CELLLN | Cell Line | NOT APPLICABLE | | 32 | 123 | TX | CSC-50 | CSC-50 | 32 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 33 | 123 | TX | CSC-50 | CSC-50 | 33 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 34 | 123 | TX | CSC-50 | CSC-50 | 34 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 35 | 123 | TX | CSC-50 | CSC-50 | 35 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 36 | 123 | TX | CSC-50 | CSC-50 | 36 | INCBTMP | Incubation Temperature | 37 | | 37 | 123 | TX | CSC-50 | CSC-50 | 37 | INCBTMPU | Incubation Temperature Unit | C | | 38 | 123 | TX | CSC-50 | CSC-50 | 38 | SWAVENM | Spectrophotometer Wavelength | 540 | | 39 | 123 | TX | CSC-50 | CSC-50 | 39 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 40 | 123 | TX | CSC-50 | CSC-50 | 40 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 41 | 123 | TX | CSC-50 | CSC-50 | 41 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 42 | 123 | TX | CSC-50 | CSC-50 | 42 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 43 | 123 | TX | CSC-50 | CSC-50 | 43 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 44 | 123 | TX | CSC-50 | CSC-50 | 44 | EXPTYP | Exposure Type | Air Liquid Interface | | 45 | 123 | TX | CSC-50 | CSC-50 | 45 | SAMTYP | Sample Type | Whole Smoke Conditioned Media | | 46 | 123 | TX | CSC-50 | CSC-50 | 46 | ITVNAM | Intervention Article Name | Tobacco ProdA | | 47 | 123 | TX | CSC-50 | CSC-50 | 47 | ITVTYPE | Intervention Article Type | PRODUCT | | 48 | 123 | TX | CSC-50 | CSC-50 | 48 | ITVCONC | Intervention Article Concentration | 50 | | 49 | 123 | TX | CSC-50 | CSC-50 | 49 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 50 | 123 | TX | CSC-50 | CSC-50 | 50 | CELLLN | Cell Line | NHK | | 51 | 123 | TX | SLS-110 | SLS-110 | 51 | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 | | 52 | 123 | TX | SLS-110 | SLS-110 | 52 | IVTDTRG | In vitro Treatment Duration Target | 48 | | 53 | 123 | TX | SLS-110 | SLS-110 | 53 | IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 54 | 123 | TX | SLS-110 | SLS-110 | 54 | IVTDU | In vitro Treatment Duration Unit | HOURS | | 55 | 123 | TX | SLS-110 | SLS-110 | 55 | INCBTMP | Incubation Temperature | 37 | | 56 | 123 | TX | SLS-110 | SLS-110 | 56 | INCBTMPU | Incubation Temperature Unit | C | | 57 | 123 | TX | SLS-110 | SLS-110 | 57 | SWAVENM | Spectrophotometer Wavelength | 540 | | 58 | 123 | TX | SLS-110 | SLS-110 | 58 | ATMRHP | Atmospheric Relative Humidity Percent | 90 | | 59 | 123 | TX | SLS-110 | SLS-110 | 59 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 60 | 123 | TX | SLS-110 | SLS-110 | 60 | SPDEVID | applicant defined device identifier | PUFFMASTER3k | | 61 | 123 | TX | SLS-110 | SLS-110 | 61 | SMKRGM | Smoking Regimen | MEDIUM INTENSITY REGIMEN | | 62 | 123 |
29PSETCD | Parent Set Code | ALL | | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 63 |
30NRU | 30| 63 | EXPTYP | Exposure Type | Air Liquid Interface |
31NRU | 31| 64 | SAMTYP | Sample Type | Liquid |
32NRU32INTRVNName of the | Intervention Article Name | Sodium Laurel Sulfate |
33NRU | 33| 66 | ITVTYPE | Intervention Article Type |
of intervention article34NRU | 34| 67 | ITVCONC | Intervention Article Concentration |
of intervention article20035NRU35| 68 | ITVCONCU | Intervention Article Concentration Unit | ug/ml |
36NRU36 |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-280The applicant chose to define the REFID values to indicate the Plate, the Column, and the Row of the wells of the 96-well plate in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G.| Rowcaps |
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| Row 1: | Shows the REFID of 123NRU that indicates the entire assay. | | Rows 2, 5, 8, 9:-4: | Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10). | | Rows 3-4, 6-7, 10-11: | Show REFID values that the sponsor chose, in this case, to represent the plate number (1 or 2), column (1 - 10), and row (A-G) of the 96-well plate. | | 123NRU (REFID values of 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL SUMMARY. If this study had recorded summary statistics for an entire trial set (e.g., across both plates for the same dose level), there would be an additional REFID for the trial set (with a LVLDESC of TRIAL SET). | | Rows 5-6Rows 3-4: | Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units that are also observational units within the SETCD of CSC-50b that have the parent Trial Set of 1-3bREFID of 123NRU. | | Rows 67-78: | Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units that are also observational units within the SETCD of CSC-50 that have the parent Trial Set REFID of 1-3. | | Row 109: | Shows the REFID of 1-10-G that indicates the experimental unit within the parent Trial Set -G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 1-10. | | Row 1110: | Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the parent Trial Set SETCD of SLS-110 that has the parent REFID of 2-10. |
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GNTXAID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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| 1 | 123 | |
ALL | NRU50b3bTRIAL SETCSC| OBSERVATIONAL SUMMARY | | 3 | 123 |
NRU | 50b3-A1-3b | 3 | EXPERIMENTAL UNITCSC| 10 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 4 | 123 |
NRU | 50b1-3H1-3b3EXPERIMENTAL UNIT| OBSERVATIONAL SUMMARY | | 5 | 123 |
NRU | 50TRIAL SET| EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 6 | 123 |
NRU50B1-33| 2 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 7 | 123 |
NRU | C| B | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 8 | 123 |
NRU | SLS11010123NRU | 2 | TRIAL SET | | 9 | 123 | NRU | SLS-110 | 2-10 | 123NRU | 2 | TRIAL SET | 10 | 123 | NRU| 3-C | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 9 | 123 | SLS-110 | 1-10-G | 1-10 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT |
11NRU | SLS-110 | 2-10-G | 2-10 | 3 | EXPERIMENTAL UNIT |
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Certain |
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| Rows 1-3: | Show the experimental unit data for GTREFID 1-3-B. |
Rows 1-2, 4-5, 10-11, 16-17: | These data (Absorbance Reading and Background Corrected Absorbance Reading) are not shown in the sample report table above but are included here for completeness of the NRU assay.
| Rowcaps |
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| Rows 1-3: | Show the experimental unit data for GTREFID 1-3-B. | | Rows 4-6: | Show the experimental unit data for GTREFID 1-3-C. | | Rows 7-9: | Show the data for the entire trial set, GTREFID=1-3. | | Rows 10-12: | Show the experimental unit data for GTREFID 1-10-G | | Rows 13-15: | Show the data for the entire trial set, GTREFID=1-10 | | Rows 16-18: | Show the experimental unit data for GTREFID 2-10-G. | | Rows 19-21: | Show the data for the entire trial set, GTREFID=2-10 | | Row 22: | Shows the data for the entire assay, GTREFID=123NRU. |
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| Dataset2 |
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| GNTXAID | | DOMAIN | GTSEQ | GTREFID | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU |
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| 1 | 123 |
NRU | GT | 1 | 1-3-B | ABSORB | Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 2 | 123 |
NRU | GT | 2 | 1-3-B | BKCABS | Background Corrected Absorbance Reading | 1.6 |
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| 1.6 | 1.6 |
| | 3 | 123 |
NRU | | GT | 3 | 1-3-B | RELABS | Relative Absorbance Reading | 77.7 |
% | % | NRU | GT | 4 | 1-3-C | ABSORB | Absorbance Reading | 1.8 |
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| 1.8 | 1.8 |
| | 5 | 123 |
NRU | GT | 5 | 1-3-C | BKCABS | Background Corrected Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 6 | 123 |
NRU | | GT | 6 | 1-3-C | RELABS | Relative Absorbance Reading | 77.4 |
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| 77.4 | 77.4 |
| | 7 | 123 |
NRU | | GT | 7 | 1-3 | RELABS | Relative Absorbance Reading | 78.2 | % | MEAN | 78.2 | 78.2 | % | | 8 | 123 |
NRU | GT | 8 | 1-3 | RELABS | Relative Absorbance Reading | 2.9 | % | STANDARD DEVIATION | 2.9 | 2.9 | % | | 9 | 123 |
NRU | GT | 9 | 1-3 | RELABS | Relative Absorbance Reading | 3.6 |
| COEFFICIENT OF VARIANCE | 3.6 | 3.6 |
| | 10 | 123 |
NRU | | GT | 10 | 1-10-G | ABSORB | Absorbance Reading | 0.7 |
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| 0.7 | 0.7 |
| | 123 |
NRU | | GT | 11 | 1-10-G | BKCABS | Background Corrected Absorbance Reading | 0.6 |
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| 0.6 | 0.6 |
| | 12 | 123 |
NRU | 11| 12 | 1-10-G | RELABS | Relative Absorbance Reading | 8.57 |
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| 8.57 | 8.57 |
| | 13 | 123 |
NRU12| 13 | 1-10 | RELABS | Relative Absorbance Reading | 8.94 | % | MEAN | 8.94 | 8.94 |
| | 14 | 123 |
NRU | 13| 14 | 1-10 | RELABS | Relative Absorbance Reading | 2.72 | % | STANDARD DEVIATION | 2.72 | 2.72 |
| | 15 | 123 |
NRU14| 15 | 1-10 | RELABS | Relative Absorbance Reading | 30.5 |
| COEFFICIENT OF VARIANCE | 30.5 | 30.5 |
| | 16 | 123 |
NRU | 15| 16 | 2-10-G | ABSORB | Absorbance Reading | 0.9 |
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| | 17 | 123 |
NRU16| 17 | 2-10-G | BKCABS | Background Corrected Absorbance Reading | 0.8 |
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| | 18 | 123 |
NRU | 17| 18 | 2-10-G | RELABS | Relative Absorbance Reading | 6.30 |
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| 6.30 | 6.30 |
| | 19 | 123 |
NRU18| 19 | 2-10 | RELABS | Relative Absorbance Reading | 5.91 | % | MEAN | 5.91 | 5.91 |
| | 20 | 123 |
NRU | 19| 20 | 2-10 | RELABS | Relative Absorbance Reading | 0.83 | % | STANDARD DEVIATION | 0.83 | 0.83 |
| | 21 | 123 |
NRU | 20| 21 | 2-10 | RELABS | Relative Absorbance Reading | 14.1 |
| COEFFICIENT OF VARIANCE | 14.1 | 14.1 |
| | 22 | 123 |
NRU21| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-132 | Effective Concentration of 50 Percent Cytotoxicity | 123 | ug/ml |
| 123 | 123 | ug/ml |
|