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Comment: TOBA-462

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Dataset wrap
Rowcaps
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 8:

Shows that the applicant's

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-356
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.
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).  

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-56

Dataset2
Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
NRU
TS1
GLPTYPGood Laboratory Practice TypeFDA
2123
NRU
TS2
GLPTYPGood Laboratory Practice TypeOECD
3123
NRU
TS1
STSTDTCStudy Start Date2022-05-25
4123
NRU
TS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay


5123
NRU
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123
NRU
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123
NRU
TS1
APPLCNTApplicant OrganizationExample Applicant Inc.
8123
NRU
TS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
9123
NRU
TS11TSTFNAMTest Facility NameExample Test Lab Name
10123
NRU
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123
NRU
TS11TFCNTRYTest Facility CountryUSA
12123
NRU
TS11STDIRStudy DirectorDr. R. Smith
13123
NRU
TS1
GLPFLGLP FlagY
14123
NRU
TS14TSTGDNAMTesting Guideline NamePublication No. 07-4519
15123
NRU
TS14TSTGDORGTesting Guideline OrganizationNIH
16123
NRU
TS14TSTGDVERTesting Guideline Version2006-11
17123
NRU
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123
NRU
TS1
GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123
NRU
TS1
SPECIESSpeciesHUMAN
20123
NRU
TS1
CELLLNCell LineNHK
Dataset wrap

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.
Row 20:Shows 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-110SLS-11029PSETCD

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

...