This example shows a report table, trial design, and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.
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Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)- red font - indicates potential for CT code lists
- green font - links to other domains
- purple font - remaining questions to resolve
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the in vitro neutral red uptake (NRU) cytotoxicity assay in example study 123.
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| title | Sample from Report Table |
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The following shows example data for study 123 in a report table. |
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| title | Study 123, Report Table |
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The following shows the tabulated data as it is represented in a report for this study. This report includes summary statistics (i.e.g. Average, Standard Deviation, Coeff. Var.); however, statistics are not included in the SEND standard and will not be represented in the SEND domains example. , average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. In the table below, the light grey shading for plate 1 are values from wells that do not contain 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) |
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| Sample ID | Smoke Regime | Replicate Number | Plate |
Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data) | Run-Port Number | Sample ID | Smoke Fraction | 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 |
1-1A1A | 0.046*
| 0.046* | 0.039* | 0.012* | 0.030* | 0.003* | 0.057* | 0.032* | 0.003* | 0.050* | 0.044* | 0.040 |
1-1A2B | 0.048* | 107 | 77.7 | 65.7 | 30.2 | 15.6 | 9.79 | 5.41 | 2.49 | 8.09 | 0.791 | 0.014* |
1-1 | A3C | 0.005* | 98.6 | 77.4 | 57.7 | 35.8 | 8.09 | 7.36 | 3.22 | 0.791 | 6.38 | 0.061 | 0.050* |
1-1 | A4D | 0.049* | 94.9 | 81.5 | 38.2 | 31.2 | 7.60 | 5.17 | 3.22 | 0.791 | 5.17 | 0.304 | 0.017* |
1-1 | A5E | 0.047* | 111 | 78.1 | 64.5 | 32.9 | 8.82 | 5.90 | 2.74 | 1.28 | 10.3 | 0.547 | 0.011* |
1-1 | A6F | 0.032* | 96.6 | 76.2 | 48.0 | 26.8 | 7.84 | 4.20 | 2.74 | 1.52 | 8.09 | 4.93 | 0.022* |
1-1 | A7G | 0.044* | 105 | 77.9 | 58.2 | 28.3 | 8.09 | 4.68 | 1.76 | 0.547 | 8.57 | 1.76 | 0.056 |
1-1A8H | 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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non-treated control wells1-1 | media without cells |
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A1A |
| 93.4 | 74.0 | 56.0 | 35.1 | 11.8 | 8.70 | 5.10 | 1.98 | 5.34 | 1.02 |
1-1 | A2B |
| 102 | 75.2 | 53.3 | 35.1 | 11.8 | 7.74 | 5.58 | 3.66 | 5.34 | 1.02 |
1-1A3C |
| 107 | 79.0 | 55.0 | 26.5 | 10.1 | 6.06 | 3.66 | 1.74 | 7.02 | 0.780 |
1-1 | A4D |
| 104 | 80.2 | 55.3 | 29.8 | 8.94 | 3.90 | 3.66 | 1.50 | 6.30 | 0.780 |
1-1 | A5E |
| 101 | 75.7 | 54.1 | 26.7 | 4.86 | 4.38 | 1.26 | 1.02 | 6.30 | 1.02 |
1-1 | A6F |
| 110 | 85.7 | 67.7 | 26.0 | 5.34 | 4.62 | 3.42 | 1.50 | 6.30 | 0.540 |
1-1A7G |
| 104 | 77.8 | 64.9 | 27.7 | 8.22 | 3.18 | 2.46 | 1.02 | 6.30 | 0.780 |
1-1 | A8H |
| 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). |
(could also be EC20 or EC30, EC70, etc.) |
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| Rows 1-2: | Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study. | | Row 3: | Shows that 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 10-13: | Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the 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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| title | ts.xpt (trial summary, study level parameters) |
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- Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
- Assumption: A Trial (study) can have more than one assay type
- Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
- Sponsor should be "applicant", how do we represent this? In text explanation in the IG? In definition in CT/Parmcd/Parm? ** Need to have CT discussion, include Erin M.**
- TK6, human keratinocyte, is this the "test system"?
- Can we draft a starting list of Study Types and Sub Types to submit to CT now?
- Is there a dictionary of species and/or strain that we would use? (see example)
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Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | NRU | | Dataset2 |
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| Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 123 |
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| TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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NRU | | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
| | 3 | 123 |
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NRU | STSTDTC | Study Start Date | 2022-
| GLPFL | GLP Flag | Y |
| | 4 | 123 | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
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4NRU | | TS | 1 |
| STITLE | Study Title | Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay |
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5NRU | | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
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6NRU | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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7NRUSSPONSORSponsor 's Organization8NRU | SPREFIDSponsor's 's| Study Reference ID |
| NOT APPLICABLE |
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9NRU | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example |
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Tox Testing 10NRU | | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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11NRU | | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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12NRU | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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13NRUTS1GLPFL | GLP Flag | Y | | TSTGDNAM | Testing Guideline Name | Publication No. 07-4519 |
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14NRU | ASTD | Assay Standard | NIH Publication No. 07-4519 | | 4 | TSTGDORG | Testing Guideline Organization | NIH |
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15NRU | ASTDVAssay Standard | Testing Guideline Version | 2006-11 |
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16NRU | | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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17NRU | SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
| GNTXAID | Genetic Toxicology Assay Identifier | NRU |
| | 19 | 123 |
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18 | 123 | NRUSalmonella enterica 19NRU?? | Test System?? | TK6 Normal Human Keratinocyte |
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| Rows 1-12: | Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay. | | Rows 13-31: | Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells. | Rows 32-50: | Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. | | Rows 51-69: | Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, 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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| ROW | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | TX | NRU | NRU_ASSAY | 1 | IVTDMIN | In vitro |
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- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct
sponsor applicant designations as specified in the trial design. - During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
- Smoke fraction? is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
- Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
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| Row | STUDYID | ASSAYID | DOMAIN | SETCD | | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 | 123 | NRU | TX | CSC-50 | CSC-50 | 1 | TRTDMIN | | Treatment Duration Minimum | 47.5 | | 2 | 123 |
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NRUCSC-50 | CSC-50TRTDTRG| IVTDTRG | In vitro Treatment Duration Target | 48 | | 3 | 123 |
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NRU | CSC-50 | CSC-50TRTDMAX| IVTDMAX | In vitro Treatment Duration Maximum | 48.5 | | 4 | 123 |
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NRU | CSC-50 | CSC-50TRTDU| IVTDU | In vitro Treatment Duration Unit | HOURS | | 5 | 123 |
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NRUCSC-50 | CSC-50 | 5 | INCBTMP | Incubation Temperature | 37 | | 6 | 123 |
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NRU | CSC-50 | CSC-50CSC-50 | 6 | INCBTMPU | Incubation Temperature Unit | C | | 7 | 123 | TX | NRU |
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TX | CSC-50 | WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS| SWAVENM | Spectrophotometer Wavelength | 540 | | 8 | 123 |
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NRU | CSC-50 | CSC-50HUMID| ATMRHP | Atmospheric Relative |
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Humidity NRUCSC-50 | CSC-50ATMCO2| ATMCO2P | Atmospheric CO2 Percent | 5 | | 10 | 123 |
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NRU | CSC-50 | CSC-50SPTOBIDSponsor tobacco CIG01aTX | CSC-50 | CSC-50 | EXPTYPExposure Type | | Smoking Regimen | MEDIUM INTENSITY REGIMEN |
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Air Liquid Interface???NRUCSC-50 | CSC-50SAMTYP | Sample Type | | SPTOBID | Applicant-defined tobacco identifier | CIG01a |
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Whole Smoke Conditioned Media???NRU | 50INTRVN | Name of the Intervention Article | | IVTDMIN | In vitro Treatment Duration Minimum | 47.5 |
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Tobacco ProdANRU | 50ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | PRODUCT | | 15 | 123 | NRU | TX | CSC-50 | CSC-50 | 15 | ITVCONC | intervention concentration | 50 |
| 16 | 123 | NRU | TX | CSC-50 | CSC-50 | 16 | ITVCONCU | intervention unit | ug/ml |
| 17 | 123 | NRU | TX | CSC-50 | CSC-50 | 17 | STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| 18 | 123 | NRU | TX | CSC-50 | CSC-50 | 18 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
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| 19 | 123 | NRU | TX | CSC-50 | CSC-50 | 19 | DUREFID | Smoking Regime | Medium Intensity Regimen |
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| 20 | 123 | NRU | TX | CSC-50 | CSC-50 | 20 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
| 21 | 123 | NRU | TX | SLS-110 | SLS-110 | 1 | TRTDMIN | Treatment Duration Minimum | 47.5 |
| 22 | 123 | NRU | TX | SLS-110 | SLS-110 | 2 | TRTDTRG | Treatment Duration Target | 48 |
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| 23 | 123 | NRU | TX | SLS-110 | SLS-110 | 3 | TRTDMAX | Treatment Duration Maximum | 48.5 |
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| 24 | 123 | NRU | TX | SLS-110 | SLS-110 | 4 | TRTDU | Treatment Duration Unit | HOURS |
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| 25 | 123 | NRU | TX | SLS-110 | SLS-110 | 5 | INCBTMP | Incubation Temperature | 37 |
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| 26 | 123 | NRU | TX | SLS-110 | SLS-110 | 6 | INCBTMPU | Incubation Temperature Unit | C
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| 27 | 123 | NRU | TX | SLS-110 | SLS-110 | 7 | WAVELGTH | Spectrophotometer WAVELENGTH IN NANOMETERS | 540 |
| 28 | 123 | NRU | TX | SLS-110 | SLS-110 | 8 | HUMID | Atmospheric Relative Humidity Percent | 90 |
| 29 | 123 | NRU | TX | SLS-110 | SLS-110 | 9 | ATMCO2 | Atmospheric CO2 Percent | 5 |
| 30 | 123 | NRU | TX | SLS-110 | SLS-110 | 10 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
| 31 | 123 | NRU | TX | SLS-110 | SLS-110 | 11 | EXPTYP | Exposure Type | Air Liquid Interface |
| 32 | 123 | NRU | TX | SLS-110 | SLS-110 | 12 | SAMTYP | Sample Type | Whole Smoke Conditioned Media |
| 33 | 123 | NRU | TX | SLS-110 | SLS-110 | 13 | INTRVN | Name of the Intervention Article | Sodium Laurel Sulfate |
| 34 | 123 | NRU | TX | SLS-110 | SLS-110 | 14 | ITVTYPE(CT e.g, Product, positive control, negative control, vehicle control, solvent control) | type of intervention article | POSITIVE CONTROL |
| 35 | 123 | NRU | TX | SLS-110 | SLS-110 | 15 | ITVCONC | intervention concentration | 200 |
| 36 | 123 | NRU | TX | SLS-110 | SLS-110 | 16 | ITVCONCU | intervention unit | ug/ml |
| 37 | 123 | NRU | TX | SLS-110 | SLS-110 | 17 | STRAIN | Strain/Substrain | Salmonella enterica enterica |
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| 38 | 123 | NRU | TX | SLS-110 | SLS-110 | 18 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3k |
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| 39 | 123 | NRU | TX | SLS-110 | SLS-110 | 19 | DUREFID | Smoking Regime | Medium Intensity Regimen |
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| 40 | 123 | NRU | TX | SLS-110 | SLS-110 | 20 | SPTOBID | Sponsor defined tobacco identifier | CIG01a |
| 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 | TX | SLS-110 | SLS-110 | 62 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 63 | 123 | TX | SLS-110 | SLS-110 | 63 | EXPTYP | Exposure Type | Air Liquid Interface | | 64 | 123 | TX | SLS-110 | SLS-110 | 64 | SAMTYP | Sample Type | Liquid | | 65 | 123 | TX | SLS-110 | SLS-110 | 65 | ITVNAM | Intervention Article Name | Sodium Laurel Sulfate | | 66 | 123 | TX | SLS-110 | SLS-110 | 66 | ITVTYPE | Intervention Article Type | POSITIVE CONTROL | | 67 | 123 | TX | SLS-110 | SLS-110 | 67 | ITVCONC | Intervention Article Concentration | | | 68 | 123 | TX | SLS-110 | SLS-110 | 68 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | | 69 | 123 | TX | SLS-110 | SLS-110 | 69 | CELLLN | Cell Line | NHK |
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The 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 2-4: | Show the REFIDs at the second level, all within the parent assay of 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 5-6: | 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 REFID of 123NRU. | | Rows 7-8: | 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 REFID of 1-3. | | Row 9: | Shows the REFID of 1-10-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 10: | Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 2-10. |
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| | Row | STUDYID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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| 1 | 123 | | 123NRU |
| 1 | ASSAY | | 2 | 123 | CSC-50 | 1-3 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 3 | 123 | SLS-110 | 1-10 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 4 | 123 | SLS-110 | 2-10 | 123NRU | 2 | OBSERVATIONAL SUMMARY | | 5 | 123 | CSC-50b | 1-3-A | 123NRU | 2 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 6 | 123 | CSC-50b | 1-3-H | 123NRU | 2 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 7 | 123 | CSC-50 | 1-3-B | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 8 | 123 | CSC-50 | 1-3-C | 1-3 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 9 | 123 | SLS-110 | 1-10-G | 1-10 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT | | 10 | 123 | SLS-110 | 2-10-G | 2-10 | 3 | EXPERIMENTAL UNIT/OBSERVATIONAL UNIT |
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| Dataset wrap |
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Certain 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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| Row | STUDYID | DOMAIN | GTSEQ | GTREFID | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTCOLSRT | GTSTRESC | GTSTRESN | GTSTRESU |
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| 1 | 123 | GT | 1 | 1-3-B | ABSORB | Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 2 | 123 | GT | 2 | 1-3-B | BKCABS | Background Corrected Absorbance Reading | 1.6 |
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| 1.6 | 1.6 |
| | 3 | 123 | GT | 3 | 1-3-B | RELABS | Relative Absorbance Reading | 77.7 |
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| 77.7 | 77.7 |
| | 4 | 123 | GT | 4 | 1-3-C | ABSORB | Absorbance Reading | 1.8 |
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| 1.8 | 1.8 |
| | 5 | 123 | GT | 5 | 1-3-C | BKCABS | Background Corrected Absorbance Reading | 1.7 |
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| 1.7 | 1.7 |
| | 6 | 123 | GT | 6 | 1-3-C | RELABS | Relative Absorbance Reading | 77.4 |
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| 77.4 | 77.4 |
| | 7 | 123 | GT | 7 | 1-3 | RELABS | Relative Absorbance Reading | 78.2 | % | MEAN | 78.2 | 78.2 | % | | 8 | 123 | GT | 8 | 1-3 | RELABS | Relative Absorbance Reading | 2.9 | % | STANDARD DEVIATION | 2.9 | 2.9 | % | | 9 | 123 | GT | 9 | 1-3 | RELABS | Relative Absorbance Reading | 3.6 |
| COEFFICIENT OF VARIANCE | 3.6 | 3.6 |
| | 10 | 123 | GT | 10 | 1-10-G | ABSORB | Absorbance Reading | 0.7 |
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| 0.7 | 0.7 |
| | 123 | GT | 11 | 1-10-G | BKCABS | Background Corrected Absorbance Reading | 0.6 |
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| 0.6 | 0.6 |
| | 12 | 123 | GT | 12 | 1-10-G | RELABS | Relative Absorbance Reading | 8.57 |
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| 8.57 | 8.57 |
| | 13 | 123 | GT | 13 | 1-10 | RELABS | Relative Absorbance Reading | 8.94 | % | MEAN | 8.94 | 8.94 |
| | 14 | 123 | GT | 14 | 1-10 | RELABS | Relative Absorbance Reading | 2.72 | % | STANDARD DEVIATION | 2.72 | 2.72 |
| | 15 | 123 | GT | 15 | 1-10 | RELABS | Relative Absorbance Reading | 30.5 |
| COEFFICIENT OF VARIANCE | 30.5 | 30.5 |
| | 16 | 123 | GT | 16 | 2-10-G | ABSORB | Absorbance Reading | 0.9 |
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| | 17 | 123 | GT | 17 | 2-10-G | BKCABS | Background Corrected Absorbance Reading | 0.8 |
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| | 18 | 123 | GT | 18 | 2-10-G | RELABS | Relative Absorbance Reading | 6.30 |
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| 6.30 | 6.30 |
| | 19 | 123 | GT | 19 | 2-10 | RELABS | Relative Absorbance Reading | 5.91 | % | MEAN | 5.91 | 5.91 |
| | 20 | 123 | GT | 20 | 2-10 | RELABS | Relative Absorbance Reading | 0.83 | % | STANDARD DEVIATION | 0.83 | 0.83 |
| | 21 | 123 | GT | 21 | 2-10 | RELABS | Relative Absorbance Reading | 14.1 |
| COEFFICIENT OF VARIANCE | 14.1 | 14.1 |
| | 22 | 123 | GT | 22 | 123NRU | | Effective Concentration of 50 Percent Cytotoxicity | 123 | ug/ml |
| 123 | 123 |
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| Expand |
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| title | ou.xpt Observational and Experimental Units Domain |
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ou.xpt. Observational and Experimental Units domain
Experimental unit - The unit to which the treatment is applied, eg. Test tube
Observational unit - The unit on which the response is measured. (This may not be the same as the experimental unit.)
| Row | STUDYID | ASSAYID | DOMAIN | SETCD (from TX) | EUID | OBUID |
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| 1 | 123 | NRU | OU | CSC-50 | 1-3-B | 1-3-B |
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| 2 | 123 | NRU | OU | CSC-50 | 1-3-C | 1-3-C |
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| 3 | 123 | NRU | OU | SLS-110 | 1-11-G | 1-11-G |
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| 4 | 123 | NRU | OU | SLS-110 | 2-11-G | 2-11-G |
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| Expand |
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| title | gt.xpt (similar to LB) |
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cells growing in plate, treat cells in the plate, then add NRU dye, then extract NRU (the OBUID) dye and transfer to another plate (put in spectrophotometer & read). .  Image Removed  Image RemovedImage Removed |
| Row | STUDYID | ASSAYID | DOMAIN | SETCD | EUID | OBUID | GTSEQ | GTTESTCD | GTTEST | GTORRES | GTORRESU | GTCOLSRT (coll. summ. result type) | GTSTRESC | GTSTRESN | GTSTRESU |
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123 | NRU | GT | CSC-50 | 1-3-B | 1-3-B | 1 | ABSORB | Absorbance Reading | 1.7 (0.0 - 2.0) | 1.7 | 1.7 | 123 | NRU | GT | CSC-50 | 1-3-B | 1-3-B | 2 | BKCABS | Background Corrected Absorbance Reading | 1.6 | 1.6 | 1.6 | 123 | NRU | GT | CSC-50 | 1-3-B | 1-3-B | 3 | RELABS | Relative Absorbance Reading | 77.7 | % | 77.7 | 77.7 | % | 123 | NRU | GT | CSC-50 | 4 | RELABS | Relative Absorbance Reading | 78.2 | % | MEAN | 78.2 | 78.2 | % | 123 | NRU | GT | CSC-50 | 5 | RELABS | Relative Absorbance Reading | 2.9 | % | STANDARD DEVIATION | 2.9 | 2.9 | % | 123 | NRU | GT | CSC-50 | 6 | RELABS | Relative Absorbance Reading | 3.6 | COEFFICIENT OF VARIANCE | 3.6 | 3.6 | 123 | NRU | GT | CSC-50 | 7 | EC50 | Effective Concentration of 50 Percent Cytotoxicity | 123 | ug/ml | 123 | 123 | ug/ml | 123 | NRU | GT | 1-2-C | 1 | RELABS | Relative Absorbance Reading | 77.4 | 77.4 | 77.4 | ... | 80 | 123 | NRU | GT | 1-11-G | 1 | RELABS | Relative Absorbance Reading | 8.57 | ug/ml | 8.57 | 8.57 | ug/ml | ... | ... | 160 | 123 | NRU | GT | 2-11-G | 1 | RELABS | Relative Absorbance Reading | 6.30 | ug/ml | 6.30 | 6.30