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Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-279

Rowcaps
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 13-20: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 21-28:

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 29-36: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.
Dataset2
RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY

2

IVTDTRGIn vitro Treatment Duration Target48
3123TXNRUNRU_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123TXNRUNRU_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123TXNRUNRU_ASSAY5INCBTMPIncubation Temperature37
6123TXNRUNRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123TXNRUNRU_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123TXNRUNRU_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123TXNRUNRU_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123TXNRUNRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123TXNRUNRU_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123TXNRUNRU_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123TXCSC-50bCSC-50-blank13PSETCD

Parent Set Code

NRU
14123TXCSC-50bCSC-50-blank14EXPTYP

Exposure Type

Air Liquid Interface
15123TXCSC-50bCSC-50-blank15SAMTYPSample TypeWhole Smoke Conditioned Media
16123TXCSC-50bCSC-50-blank16ITVNAMName of the Intervention ArticleTobacco ProdA
17123TXCSC-50bCSC-50-blank17ITVTYPEIntervention Article TypePRODUCT
18123TXCSC-50bCSC-50-blank18ITVCONC

Intervention Article Concentration

50
19123TXCSC-50bCSC-50-blank19ITVCONCUIntervention Article Concentration Unitug/ml
20123TXCSC-50bCSC-50-blank20CELLLNCell LineNOT APPLICABLE
21123TXCSC-50CSC-5021PSETCD

Parent Set Code

NRU
22123TXCSC-50CSC-5022EXPTYP

Exposure Type

Air Liquid Interface
23123TXCSC-50CSC-5023SAMTYPSample TypeWhole Smoke Conditioned Media
24123TXCSC-50CSC-5024ITVNAMIntervention Article NameTobacco ProdA
25123TXCSC-50CSC-5025ITVTYPEIntervention Article TypePRODUCT
26123TXCSC-50CSC-5026ITVCONC

Intervention Article Concentration

50
27123TXCSC-50CSC-5027ITVCONCUIntervention Article Concentration Unitug/ml
28123TXCSC-50CSC-5028CELLLNCell LineNHK
29123TXSLS-110

SLS-110

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-599

29PSETCD

Parent Set Code

NRU
30123TXSLS-110SLS-11030EXPTYP

Exposure Type

Air Liquid Interface
31123TXSLS-110SLS-11031SAMTYPSample TypeLiquid
32123TXSLS-110SLS-11032ITVNAMIntervention Article NameSodium Laurel Sulfate
33123TXSLS-110SLS-11033ITVTYPEIntervention Article TypePOSITIVE CONTROL
34123TXSLS-110SLS-11034ITVCONC

Intervention Article Concentration

110

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-600

35123TXSLS-110SLS-11035ITVCONCUIntervention Article Concentration Unitug/ml
36123TXSLS-110SLS-11036CELLLNCell LineNHK

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-461

Dataset wrap
Namerelref

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-280

Rowcaps
Row 1:Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9: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) which have LVLDESC of OBSERVATIONAL UNIT.  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 3-4, 6-7, 10-11: Show REFID values that the applicant chose, in this case, to represent the plate number (1 or 2), column (1 - 12), and row (A-G) of the 96-well plates.
Rows 3-4:Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent trial set of 1-3b.
Rows 6-7:Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent trial set of 1-3.
Row 10:Shows the REFID of 1-10-G that indicates the experimental unit within the parent trial set of 1-10.
Row 11: Shows the REFID of 2-10-G that indicates the experimental unit within the parent trial set of 2-10.
Dataset2
tableidrelref

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123

NRU

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-475

123NRU
1ASSAY
2123

CSC-50b

1-3b123NRU2OBSERVATIONAL UNIT
3123

CSC-50b

1-3-A1-3b3EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
4123

CSC-50b

1-3-H1-3b3EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
5123CSC-501-3123NRU2OBSERVATIONAL UNIT
6123CSC-501-3-B1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
7123CSC-501-3-C1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
8123SLS-1101-10123NRU2OBSERVATIONAL UNIT
9123SLS-1102-10123NRU2OBSERVATIONAL UNIT
10123SLS-1101-10-G1-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
11123SLS-1102-10-G2-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT

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