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Dataset wrap
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 13-31: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.
Dataset2
ROWSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY2IVTDTRGIn 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-blank13IVTDMINIn vitro Treatment Duration Minimum47.5
14123TXCSC-50bCSC-50-blank14IVTDTRGIn vitro Treatment Duration Target48
15123TXCSC-50bCSC-50-blank15IVTDMAXIn vitro Treatment Duration Maximum48.5
16123TXCSC-50bCSC-50-blank16IVTDUIn vitro Treatment Duration UnitHOURS
17123TXCSC-50bCSC-50-blank17INCBTMPIncubation Temperature37
18123TXCSC-50bCSC-50-blank18INCBTMPUIncubation Temperature UnitC
19123TXCSC-50bCSC-50-blank19SWAVENMSpectrophotometer Wavelength540
20123TXCSC-50bCSC-50-blank20ATMRHPAtmospheric Relative Humidity Percent90
21123TXCSC-50bCSC-50-blank21ATMCO2PAtmospheric CO2 Percent5
22123TXCSC-50bCSC-50-blank22SPDEVIDapplicant defined device identifierPUFFMASTER3k
23123TXCSC-50bCSC-50-blank23SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
24123TXCSC-50bCSC-50-blank24SPTOBID

Applicant-defined tobacco identifier

CIG01a
25123TXCSC-50bCSC-50-blank25EXPTYP

Exposure Type

Air Liquid Interface
26123TXCSC-50bCSC-50-blank26SAMTYPSample TypeWhole Smoke Conditioned Media
27123TXCSC-50bCSC-50-blank27ITVNAMName of the Intervention ArticleTobacco ProdA
28123TXCSC-50bCSC-50-blank28ITVTYPEIntervention Article TypePRODUCT
29123TXCSC-50bCSC-50-blank29ITVCONC

Intervention Article Concentration

50
30123TXCSC-50bCSC-50-blank30ITVCONCUIntervention Article Concentration Unitug/ml
31123TXCSC-50bCSC-50-blank31CELLLNCell LineNOT APPLICABLE
32123TXCSC-50CSC-5032IVTDMINIn vitro Treatment Duration Minimum47.5
33123TXCSC-50CSC-5033IVTDTRGIn vitro Treatment Duration Target48
34123TXCSC-50CSC-5034IVTDMAXIn vitro Treatment Duration Maximum48.5
35123TXCSC-50CSC-5035IVTDUIn vitro Treatment Duration UnitHOURS
36123TXCSC-50CSC-5036INCBTMPIncubation Temperature37
37123TXCSC-50CSC-5037INCBTMPUIncubation Temperature UnitC
38123TXCSC-50CSC-5038SWAVENMSpectrophotometer Wavelength540
39123TXCSC-50CSC-5039ATMRHPAtmospheric Relative Humidity Percent90
40123TXCSC-50CSC-5040ATMCO2PAtmospheric CO2 Percent5
41123TXCSC-50CSC-5041SPDEVIDapplicant defined device identifierPUFFMASTER3k
42123TXCSC-50CSC-5042SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
43123TXCSC-50CSC-5043SPTOBID

Applicant-defined tobacco identifier

CIG01a
44123TXCSC-50CSC-5044EXPTYP

Exposure Type

Air Liquid Interface
45123TXCSC-50CSC-5045SAMTYPSample TypeWhole Smoke Conditioned Media
46123TXCSC-50CSC-5046ITVNAMIntervention Article NameTobacco ProdA
47123TXCSC-50CSC-5047ITVTYPEIntervention Article TypePRODUCT
48123TXCSC-50CSC-5048ITVCONC

Intervention Article Concentration

50
49123TXCSC-50CSC-5049ITVCONCUIntervention Article Concentration Unitug/ml
50123TXCSC-50CSC-5050CELLLNCell LineNHK
51123TXSLS-110SLS-11051IVTDMINIn vitro Treatment Duration Minimum47.5
52123TXSLS-110SLS-11052IVTDTRGIn vitro Treatment Duration Target48
53123TXSLS-110SLS-11053IVTDMAXIn vitro Treatment Duration Maximum48.5
54123TXSLS-110SLS-11054IVTDUIn vitro Treatment Duration UnitHOURS
55123TXSLS-110SLS-11055INCBTMPIncubation Temperature37
56123TXSLS-110SLS-11056INCBTMPUIncubation Temperature UnitC
57123TXSLS-110SLS-11057SWAVENMSpectrophotometer Wavelength540
58123TXSLS-110SLS-11058ATMRHPAtmospheric Relative Humidity Percent90
59123TXSLS-110SLS-11059ATMCO2PAtmospheric CO2 Percent5
60123TXSLS-110SLS-11060SPDEVIDapplicant defined device identifierPUFFMASTER3k
61123TXSLS-110SLS-11061SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
62123TXSLS-110SLS-11062SPTOBID

Applicant-defined tobacco identifier

CIG01a
63123TXSLS-110SLS-11063EXPTYP

Exposure Type

Air Liquid Interface
64123TXSLS-110SLS-11064SAMTYPSample TypeLiquid
65123TXSLS-110SLS-11065ITVNAMIntervention Article NameSodium Laurel Sulfate
66123TXSLS-110SLS-11066ITVTYPEIntervention Article TypePOSITIVE CONTROL
67123TXSLS-110SLS-11067ITVCONC

Intervention Article Concentration

110

68123TXSLS-110SLS-11068ITVCONCUIntervention Article Concentration Unitug/ml
69123TXSLS-110SLS-11069CELLLNCell LineNHK

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

Dataset wrap
Namerelref

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 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-601
in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G.

Rowcaps
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.
Dataset2
tableidrelref
Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123

NRU

123NRU
1ASSAY
2123CSC-501-3123NRU2OBSERVATIONAL SUMMARY
3123SLS-1101-10123NRU2OBSERVATIONAL SUMMARY
4123SLS-1102-10123NRU2OBSERVATIONAL SUMMARY
5123

CSC-50b

1-3-A

123NRU

2EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
6123

CSC-50b

1-3-H123NRU2EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
7123CSC-501-3-B1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
8123CSC-501-3-C1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
9123SLS-1101-10-G1-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
10123SLS-1102-10-G2-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT

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