This is an example showing example shows a sample report table, trial design and results data of for 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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| title | Sample Report Table for Study 123, Raw data (for reference only, will be deleted?) |
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| Rows 1-2: | Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study. | | Row 8: | Shows that the sponsor's study reference ID is not applicable. | | Rows 9-12: | 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. |
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Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 123 | NRU | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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| 2 | 123 | NRU | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
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| 3 | 123 | NRU | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
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| 4 | 123 | NRU | TS | 1 |
| STITLE | Study Title | Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay |
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| 5 | 123 | NRU | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
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| 6 | 123 | NRU | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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| 7 | 123 | NRU | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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| 8 | 123 | NRU | TS | 1 |
| SPREFID | Sponsor Study Reference ID |
| NOT APPLICABLE |
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| 9 | 123 | NRU | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Test Lab Name |
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| 10 | 123 | NRU | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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| 11 | 123 | NRU | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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| 12 | 123 | NRU | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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| 13 | 123 | NRU | TS | 1 |
| GLPFL | GLP Flag | Y |
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| 14 | 123 | NRU | TS | 1 |
| ASTD | Assay Standard | NIH Publication No. 07-4519 |
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| 15 | 123 | NRU | TS | 1 |
| ASTDV | Assay Standard Version | 2006-11 |
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| 16 | 123 | NRU | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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| 17 | 123 | NRU | TS | 1 |
| SSSTYP | Study Sub Type | In Vitro Neutral Red Uptake |
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| 18 | 123 | NRU | TS | 1 |
| SPECIES | Species | Hamster |
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| 19 | 123 | NRU | TS | 1 |
| TESTSYS | Test System | CHO |
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title | ts |
This example trial set dataset, tx.xpt, shows information about the test conditions for set A1 and A2 in this example study, 123. Set A1 and A2 can be seen in the first and second rows respectively of Table 1 in the Sample Report table for Study 123 (above). For brevity, the trial sets dataset, tx.xpt, and the findings dataset, gt.xpt do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.
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| Rows 1-24: | Show trial set parameters and trial set values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0". Set A1 is associated with the first row in the sample report table for study 123. | | Rows 25-47: | Show trial set parameters and trial set values that comprise the test conditions for trial set A2. Set A2 is the data for the short term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250". Set A2 is associated with the second row in the sample report table for study 123. |
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| Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 123 | MNvit | TX | A1 | ST+S9_C0 | 2 | METACT | Metabolic Activation | +S9 | | 2 | 123 | MNvit | TX | A1 | ST+S9_C0 | 3 | METACTFL | Y/N presence of metabolic activation | Y |
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| 3 | 123 | MNvit | TX | A1 | ST+S9_C0 | 4 | TRTDMIN | Treatment Duration Minimum | 3 |
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| 4 | 123 | MNvit | TX | A1 | ST+S9_C0 | 5 | TRTDTRG | Treatment Duration Target | 3.5 |
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| 5 | 123 | MNvit | TX | A1 | ST+S9_C0 | 6 | TRTDMAX | Treatment Duration Maximum | 4 |
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| 6 | 123 | MNvit | TX | A1 | ST+S9_C0 | 7 | TRTDU | Treatment Duration Unit | HOURS | | 7 |
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(trial summary, study level parameters)- 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
- Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
- Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
Row | STUDYID | ASSAYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | MNvit | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | 2 | 123 | MNvit | TS | 2 | GLPTYP | Good Laboratory Practice Type | OECD | 3 | 123 | MNvit | TS | 1 | STSTDTC | Study Start Date | 2022-05-25 | 4 | 123 | MNvit | TS | 1 | STITLE | Study Title | Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay | 5 | 123 | MNvit | TS | 1 | SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 | 6 | 123 | MNvit | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 | 7 | 123 | MNvit | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | 8 | 123 | MNvit | TS | 1 | SPREFID | Sponsor's Study Reference ID | NOT APPLICABLE | 9 | 123 | MNvit | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | 10 | 123 | MNvit | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | 11 | 123 | MNvit | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | 12 | 123 | MNvit | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith | 13 | 123 | MNvit | TS | 1 | GLPFL | GLP Flag | Y | 14 | 123 | MNvit | TS | 1 | ASTD | Assay Standard | OECD Test No. 487 | 15 | 123 | MNvit | TS | 1 | ASTDV | Assay Standard Version | 2016-07-29 | 16 | 123 | MNvit | TS | 1 | SSTYP | Study Type | GENOTOXICITY IN VITRO | 17 | 123 | MNvit | TS | 1 | SSSTYP | Study Sub Type | In Vitro Micronucleus | 18 | 123 | MNvit | TS | 1 | SPECIES | Species | Homo Sapiens | | Expand |
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- Assumption: SPDEVID (sponsor defined device identifier), and Test System should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
- Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
- Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
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| Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1(table 1, row 1, ST exposure with S9)
ST+S9C0 | 1 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | | ST+S9_C0 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 | | 8 |
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2S9C02METACT | Metabolic Activation (this is the type of activation used) | +S9 | | RCVDTRG | Recovery Duration Target | 24 | | 9 |
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3S9C03METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | | RCVDMAX | Recovery Duration Maximum | 24.5 | | 10 |
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4S9C04TRTDMINTreatment Minimum35S9C05TRTDTRG | Treatment Duration Target | 3.5 | | INCBTMP | Incubation Temperature | 37 | | 12 |
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6S9C06TRTDMAX | Treatment Duration Maximum | 4 | | INCBTMPU | Incubation Temperature Unit | C | | 13 |
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7S9C07TRTDU | Treatment Duration Unit | HOURS | | HUMID | Atmospheric Relative Humidity Percent | 50 | | 14 |
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8S9C0823.RCVDMIN | Recovery Duration Minimum | | ATMCO2 | Atmospheric CO2 Percent |
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9S9C09RCVDTRG | Recovery Duration Target | 24 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 16 |
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10S9C010RCVDMAX | Recovery Duration Maximum | 24.5 | 11+S9C011 | RCVDU | Recovery Duration Unit | HOURS | | +S9_C0 | 18 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | | 18 |
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12S9C012INCBTMP | Incubation Temperature | 37 | | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 19 |
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13S9C013INCBTMPU | Incubation Temperature Unit | C | | ITVTYPE | type of intervention article | Negative Control | | 20 |
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14S9C014HUMID | Atmospheric Relative Humidity Percent | 50 | | ITVCONC | Concentration of intervention article | 0 | | 21 |
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15S9C015ATMCO2 | Atmospheric CO2 Percent | 5 | | ITVCONCU | Concentration Unit | ug/ml | | 22 |
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16S9C016SPTOBID tobaccoCIG01a17S9C017EXPTYP | | Submerged | DUREFID | Smoke Regimen | Medium Intensity Regimen | | 24 |
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18A1S9C018SAMTYP Sample Type | Total Particulate Matter in DMSO | | Metabolic Activation | +S9 | | 25 |
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19A1S9C019INTRVN | Name of the Intervention Article | Tobacco ProdA | | METACTFL | Y/N presence of metabolic activation | Y | | 26 |
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20A1S9C020 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Negative Control | | S9_C1250 | 4 | TRTDMIN | Treatment Duration Minimum | 3 | | 27 |
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21A1S9C021ITVCONC | Concentration of intervention article | 0 | | TRTDTRG | Treatment Duration Target | 3.5 | | 28 |
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22A1S9C022ITVCONCU | Concentration Unit | ug/ml | | TRTDMAX | Treatment Duration Maximum | 4 | | 29 |
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23A1S9C023SPDEVID | Sponsor defined device identifier | PUFFMASTER3K | | TRTDU | Treatment Duration Unit | HOURS | | 30 |
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24A1S9C024DUREFID | Smoke Regimen | Medium Intensity Regimen | | RCVDMIN | Recovery Duration Minimum | 23.5 | | 31 |
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25(table 1, row 2, exposure with S9 at concentration 1250)ST-12501TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | | RCVDTRG | Recovery Duration Target | 24 | | 32 |
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26-12502METACT | Metabolic Activation (this is the type of activation used) | +S9 | | RCVDMAX | Recovery Duration Maximum | 24.5 | | 33 |
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27-12503METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | | RCVDU | Recovery Duration Unit | HOURS | | 34 |
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28-12504TRTDMIN | Treatment Duration Minimum | 3 | | INCBTMP | Incubation Temperature | 37 | | 35 |
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29-12505TRTDTRG | Treatment Duration Target | 3.5 | | INCBTMPU | Incubation Temperature Unit | C | | 36 |
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30-12506TRTDMAX | Treatment Duration Maximum | 4 | | HUMID | Atmospheric Relative Humidity Percent | 50 | | 37 |
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31-12507TRTDU | Treatment Duration Unit | HOURS | | ATMCO2 | Atmospheric CO2 Percent | 5 | | 38 |
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32-12508RCVDMIN | Recovery Duration Minimum | 23.5 | | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 39 |
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33-12509RCVDTRG | Recovery Duration Target | 24 | | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | | 40 |
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34-125010RCVDMAX | Recovery Duration Maximum | 24.5 | | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | | 41 |
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35-125011RCVDU | Recovery Duration Unit | HOURS | | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 42 |
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36S9-125012 | INCBTMP | Incubation Temperature | 37 | | S9_C1250 | 20 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Product | | 43 |
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37-125013INCBTMPU | Incubation Temperature Unit | C | | ITVCONC | Concentration of intervention article | 1250 | | 44 |
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38-125014HUMID | Atmospheric Relative Humidity Percent | 50 | | ITVCONCU | Concentration Unit | ug/ml | | 45 |
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39-125015ATMCO2 | Atmospheric CO2 Percent | 5 | | SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 | | 46 |
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40 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 24 | DUREFID | Smoke Regimen | High Intensity Regimen |
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A1: Image Added
A2: Image Added -1250| 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 41 | 123 | MNvit | TX | A2 | ST+S9-1250 | 17 | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | 42 | | Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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1 |
A2-125018 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | 1 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | | 2 |
43A2-125019INTRVN | Name of the Intervention Article | Tobacco ProdA | | METACT | Metabolic Activation (this is the type of activation used) | +S9 | | 3 |
44A2-125020ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Product | | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | | 4 |
45A2-125021ITVCONC | Concentration of intervention article | 1250 | | TRTDMIN | Treatment Duration Minimum | 3 | | 5 |
46A2-125022ITVCONCU | Concentration Unit | ug/ml | | TRTDTRG | Treatment Duration Target | 3.5 | | 6 |
47A2-125023SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 | | TRTDMAX | Treatment Duration Maximum | 4 | | 7 |
48A2-125024DUREFID | Smoke Regimen | High Intensity Regimen | ... | |
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| title | di.xpt (a study reference domain for unique device identification) |
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di.xpt (copied v1.0 of medical devices IG)
- This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly.
- Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?
Example 1
This shows records for two three devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device.
- Rows 1-5 show the records for a device given a SPDEVID of PUFFMASTER3K
- Rows 5-8 show the records for a device given a SPDEVID of PUFFMASTER2023
- Rows 9-12 show
Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
1 | 123 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | ENDS |
2 | 123 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme Machines |
3 | 123 | DI | PUFFMASTER3K | 3 | MODEL | Model Number | 45-JFI |
4 | 123 | DI | PUFFMASTER3K | 4 | SERIAL | Serial Number | 456789132-AXQ |
5 | 123 | DI | PUFFMASTER3K | 5 | FDAUDI | FDA Unique Device Identifier | 456789123xyz |
6 | 123 | DI | PUFFMASTER2023 | 1 | DEVTYPE | Device Type | SmokeMachine |
7 | 123 | DI | PUFFMASTER2023 | 2 | MANUF | Manufacturer | Acme Machines |
8 | 123 | DI | PUFFMASTER2023 | 3 | MODEL | Model Number | 62-PLC |
9 | 123 | DI | PUFFMASTER2023 | 4 | SERIAL | Serial Number | 215964564-NFS |
10 | 123 | DI | UsualCTCigarette | 1 | DEVTYPE | Device Type | Combustible Tobacco Cigarette |
11 | 123 | DI | UsualCTCigarette | 2 | MANUF | Manufacturer | Philip Morris International |
12 | 123 | DI | UsualCTCigarette | 3 | MODEL | Model Number | Marlboro Red |
13 | 123 | DI | UsualCTCigarette | 4 | SERIAL | Serial Number | 123456789 |
| TRTDU | Treatment Duration Unit | HOURS | | 8 | 123 | MNvit | TX | A1 | ST+S9_C0 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 | | 9 | 123 | MNvit | TX | A1 | ST+S9_C0 | 9 | RCVDTRG | Recovery Duration Target | 24 | | 10 | 123 | MNvit | TX | A1 | ST+S9_C0 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 | | 11 | 123 | MNvit | TX | A1 | ST+S9_C0 | 11 | RCVDU | Recovery Duration Unit | HOURS | | 12 | 123 | MNvit | TX | A1 | ST+S9_C0 | 12 | INCBTMP | Incubation Temperature | 37 | | 13 | 123 | MNvit | TX | A1 | ST+S9_C0 | 13 | INCBTMPU | Incubation Temperature Unit | C | | 14 | 123 | MNvit | TX | A1 | ST+S9_C0 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 | | 15 | 123 | MNvit | TX | A1 | ST+S9_C0 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 | | 16 | 123 | MNvit | TX | A1 | ST+S9_C0 | 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 17 | 123 | MNvit | TX | A1 | ST+S9_C0 | 17 | EXPTYP | | Submerged | | 18 | 123 | MNvit | TX | A1 | ST+S9_C0 | 18 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | | 19 | 123 | MNvit | TX | A1 | ST+S9_C0 | 19 | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 20 | 123 | MNvit | TX | A1 | ST+S9_C0 | 20 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Negative Control | | 21 | 123 | MNvit | TX | A1 | ST+S9_C0 | 21 | ITVCONC | Concentration of intervention article | 0 | | 22 | 123 | MNvit | TX | A1 | ST+S9_C0 | 22 | ITVCONCU | Concentration Unit | ug/ml | | 23 | 123 | MNvit | TX | A1 | ST+S9_C0 | 23 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K | | 24 | 123 | MNvit | TX | A1 | ST+S9_C0 | 24 | DUREFID | Smoke Regimen | Medium Intensity Regimen | | 25 | 123 | MNvit | TX | A2 (table 1, row 2, ST exposure with S9 at concentration 1250) | ST+S9_C1250 | 1 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | | 26 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 2 | METACT | Metabolic Activation (this is the type of activation used) | +S9 | | 27 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 3 | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | | 28 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 4 | TRTDMIN | Treatment Duration Minimum | 3 | | 29 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 5 | TRTDTRG | Treatment Duration Target | 3.5 | | 30 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 6 | TRTDMAX | Treatment Duration Maximum | 4 | | 31 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 7 | TRTDU | Treatment Duration Unit | HOURS | | 32 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 | | 33 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 9 | RCVDTRG | Recovery Duration Target | 24 | | 34 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 | | 35 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 11 | RCVDU | Recovery Duration Unit | HOURS | | 36 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 12 | INCBTMP | Incubation Temperature | 37 | | 37 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 13 | INCBTMPU | Incubation Temperature Unit | C | | 38 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 | | 39 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 | | 40 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | | 41 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 17 | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | | 42 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 18 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | | 43 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 19 | INTRVN | Name of the Intervention Article | Tobacco ProdA | | 44 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 20 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Product | | 45 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 21 | ITVCONC | Concentration of intervention article | 1250 | | 46 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 22 | ITVCONCU | Concentration Unit | ug/ml | | 47 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 23 | SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 | | 48 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 24 | DUREFID | Smoke Regimen | High Intensity Regimen |
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| title | du.xpt smoke regimen definition (a findings domain for device in-use properties) |
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We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine - Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
- Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
- The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"
du.xpt | STUDYID | DOMAIN | SPDEVID | DUSEQ | DUREFID | DUGRPID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU |
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1 | 123 | DU | PUFFMASTER3K | 1 | Medium Intensity Regimen | PUFFPROF | Puff Profile | SQUARE | SQUARE | 2 | 123 | DU | PUFFMASTER3K | 2 | Medium Intensity Regimen | PUFFDUR | Puff Duration | 1.25 | sec | 1.25 | 1.25 | sec | 3 | 123 | DU | PUFFMASTER3K | 3 | Medium Intensity Regimen | PUFFINT | Puff Interval | 3 | PUFF/min | 3 | 3 | PUFF/min | 4 | 123 | DU | PUFFMASTER3K | 4 | Medium Intensity Regimen | PUFFBLCK | Puff Block | 25 | % | 25 | 25 | % | 5 | 123 | DU | PUFFMASTER3K | 5 | Medium Intensity Regimen | NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | 6 | 123 | DU | PUFFMASTER3K | 6 | Medium Intensity Regimen | PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | 7 | 123 | DU | PUFFMASTER3K | 7 | Medium Intensity Regimen | PUFFRNG | Puff Range | 100-200 | 100-200 | | 8 | 123 | DU | PUFFMASTER3K | 8 | Medium Intensity Regimen | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s |
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| 9 | 123 | DU | PUFFMASTER3K | 9 | Medium Intensity Regimen | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
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10 | 123 | DU | PUFFMASTER2023 | 1 | Canadian Intense Regime | PUFFPROF | Puff Profile | SQUARE | SQUARE | 11 | 123 | DU | PUFFMASTER2023 | 2 | Canadian Intense Regime | PUFFDUR | Puff Duration | 2.00 | sec | 2.00 | 2.00 | sec | 12 | 123 | DU | PUFFMASTER2023 | 3 | Canadian Intense Regime | PUFFINT | Puff Interval | 4 | PUFF/min | 4 | 4 | PUFF/min | 13 | 123 | DU | PUFFMASTER2023 | 4 | Canadian Intense Regime | PUFFBLCK | Puff Block | 0 | % | 0 | 0 | % | 14 | 123 | DU | PUFFMASTER2023 | 5 | Canadian Intense Regime | NUMPUFF | Total Number of Puffs | 200 | PUFF | 200 | 200 | PUFF | 15 | 123 | DU | PUFFMASTER2023 | 6 | Canadian Intense Regime | PUFFVOL | Puff Volume | 10 | mL | 10 | 10 | mL | 16 | 123 | DU | PUFFMASTER2023 | 7 | Canadian Intense Regime | PUFFRNG | Puff Range | 100-200 | 100-200 | | 17 | 123 | DU | PUFFMASTER2023 | 8 | Canadian Intense Regime | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s |
|---|
18 | 123 | DU | PUFFMASTER2023 | 9 | Canadian Intense Regime | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF |
| Expand |
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| Row | STUDYID | ASSAYID | DOMAIN | SETCD (from TX)SETCD | EUID | OBUID |
|---|
| 1 | 123 | MNvit | EI | A1 | C0 |
|
|---|
| 2 | 123 | MNvit | EI | A2 | C1250 |
|
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| Expand |
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| title | gt.xpt (similar to LB) |
|---|
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A1:
A2:
- Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
ASSAYID| GNTXAID | DOMAIN | EUID | OBUID
| REFID | GTSEQ | GTTESTCD | GTTEST | GTCELLEV
(cells evaluated) | GTORRES | GTORRESU | GTCOLSRT ??? | GTSTRESC | GTSTRESN | GTSTRESU | GTDTC |
|---|
| 1 | 123 | MNvit | GT | C0 |
|
| 1 | RICC | Relative Increase in Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | | 2 | 123 | MNvit | GT | C0 |
|
| 2 | RCC | Relative Cell Count | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | | 3 | 123 | MNvit | GT | C0 |
|
| 3 | RPD | Relative Population Doubling | 154 | 0 | % |
| 0 | 0 | % | 2022-05-25 | | 4 | 123 | MNvit | GT | C0 |
|
| 4 | MNCELLS | Micronucleated Cells | 2205 | 15 | Cells |
| 15 | 15 | Cells | 2022-05-25 | | 5 | 123 | MNvit | GT | C0 |
|
| 5 | MNCELLS | Micronucleated Cells | 2474 | 13 | Cells |
| 13 | 13 | Cells | 2022-05-25 | | 6 | 123 | MNvit | GT | C0 |
|
| 6 | MNCELLS | Micronucleated Cells | 2758 | 17 | Cells |
| 17 | 17 | Cells | 2022-05-25 | | 7 | 123 | MNvit | GT | C0 |
|
| 7 | MNCELLS | Micronucleated Cells | 2669 | 12 | Cells |
| 12 | 12 | Cells | 2022-05-25 | | 8 | 123 | MNvit | GT | C0 |
|
| 8 | AVGREL | Average Relative MN Frequency |
| 0.57 | % |
| 0.57 | 0.57 | % | 2022-05-25 | | 9 | 123 | MNvit | GT | C1250 |
|
| 1 | RICC | Relative Increase in Cell Count | 134 | 15.7 | % |
| 15.7 | 15.7 | % | 2022-05-25 | | 10 | 123 | MNvit | GT | C1250 |
|
| 2 | RCC | Relative Cell Count | 134 | 13.0 | % |
| 13.0 | 13.0 | % | 2022-05-25 | | 11 | 123 | MNvit | GT | C1250 |
|
| 3 | RPD | Relative Population Doubling | 134 | 7.9 | % |
| 7.9 | 7.9 | % | 2022-05-25 | | 12 | 123 | MNvit | GT | C1250 |
|
| 4 | MNCELLS | Micronucleated Cells | 3266 | 20 | Cells |
| 20 | 20 | Cells | 2022-05-25 | | 13 | 123 | MNvit | GT | C1250 |
|
| 5 | MNCELLS | Micronucleated Cells | 2190 | 17 | Cells |
| 17 | 17 | Cells | 2022-05-25 | | 14 | 123 | MNvit | GT | C1250 |
|
| 6 | MNCELLS | Micronucleated Cells | 2758 | 13 | Cells |
| 13 | 13 | Cells | 2022-05-25 | | 15 | 123 | MNvit | GT | C1250 |
|
| 7 | MNCELLS | Micronucleated Cells | 2714 | 21 | Cells |
| 21 | 21 | Cells | 2022-05-25 | | 16 | 123 | MNvit | GT | C1250 |
|
| 8 | AVGREL | Average Relative MN Frequency |
| 0.66 | % |
| 0.66 | 0.66 | % | 2022-05-25 |
|