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Comment: TOBA-748 CT revisions

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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 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=2) 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

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
STITLEStudy Title

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


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
APPLCNT

Applicant Organization

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

Example Applicant, Inc.
8123NRUTS1
SPREFIDAPREFIDStudy Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Test Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
12123NRUTS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1
GLPFLGLP FlagY
14123NRUTS12TSTGDNAMTesting Guideline NameGUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15123NRUTS12TSTGDORGTesting Guideline OrganizationOECD
16123NRUTS12TSTGDVERTesting Guideline Version29-July-2016
17123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123NRUTS1
SSSTYPStudy Sub TypeMICRONUCLEUS TEST
19123NRUTS1
SPECIESSpeciesHUMAN
20123NRUTS1
CELLLNCell Line

TK6 LYMPHOBLASTOID


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Dataset wrap
Nametx
Rowcaps
Rows 1-17:

Show the experimental parameters that are common for table 1 of study 123.

Rows 18, 25: 

Show that sets A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.

Rows 18-24:

Show trial set parameters and 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 25-31:

Show trial set parameters and 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.

Dataset2
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL

1

123MNvitTXAST+S9

1

METACTMETACTINDMetabolic ActivationActivating Agent Name+S9
2123MNvitTXAST+S92METACTFLY/N presence of metabolic activationPresence of Metabolic Activation FlagY
3123MNvitTXAST+S93TRTDMIN

IVTDMIN

In vitro Treatment Duration Minimum3
4123MNvitTXAST+S94TRTDTRGIVTDTRGIn vitro Treatment Duration Target3.5
5123MNvitTXAST+S95TRTDMAXIVTDMAXIn vitro Treatment Duration Maximum4
6123MNvitTXAST+S96TRTDUIVTDUIn vitro Treatment Duration UnitHOURS
7123MNvitTXAST+S97RCVDMINRecovery Duration Minimum23.5
8123MNvitTXAST+S98RCVDTRGRecovery Duration Target24
9123MNvitTXAST+S99RCVDMAXRecovery Duration Maximum24.5
10123MNvitTXAST+S910RCVDURecovery Duration UnitHOURS
11123MNvitTXAST+S911INCBTMPIncubation Temperature37
12123MNvitTXAST+S912INCBTMPUIncubation Temperature UnitC
13123MNvitTXAST+S913HUMIDATMRHPAtmospheric Relative Humidity Percent50
14123MNvitTXAST+S914ATMCO2ATMCO2PAtmospheric CO2 Percent5
15123MNvitTXAST+S915

SPTOBID

Applicant-defined tobacco identifier

CIG01a
16123MNvitTXAST+S916EXPTYP

Exposure Type

Submerged
17123MNvitTXAST+S917SAMTYP

Sample Type

Total Particulate Matter in DMSO
18123MNvitTXA1ST+S9_C0

1

PSETCD

Parent Set Code

A
19123MNvitTXA1ST+S9_CO2INTRVNITVNAM

Name of the Intervention Article Name

Tobacco ProdA
20123MNvitTXA1ST+S9_C03ITVTYPE

type of intervention articleIntervention Article Type

Negative Control
21123MNvitTXA1ST+S9_C04ITVCONCIntervention Article Concentration of intervention article0
22123MNvitTXA1ST+S9_C05ITVCONCUIntervention Article Concentration Unitug/ml
23123MNvitTXA1ST+S9_C06

SPDEVID

Applicant-defined device identifierPUFFMASTER3K
24123MNvitTXA1ST+S9_C07

DUREFIDSMKRGM

Smoke RegimenMedium Intensity Regimen
25123MNvitTXA2ST+S9_C1250

1

PSETCD

Parent Set Code

A
26123MNvitTXA2ST+S9_C12502INTRVNITVNAM

Name of the Intervention Article Name

Tobacco ProdA
27123MNvitTXA2ST+S9_C12503ITVTYPE

type of intervention articleIntervention Article Type

Product
28123MNvitTXA2ST+S9_C12504ITVCONCIntervention Article Concentration of intervention article1250
29123MNvitTXA2ST+S9_C12505ITVCONCUIntervention Article Concentration Unitug/ml
30123MNvitTXA2ST+S9_C12506SPDEVIDApplicant-defined device identifierDevice IdentifierPUFFMASTER2023
31123MNvitTXA2ST+S9_C12507DUREFID

SMKRGM

Smoke RegimenHigh Intensity Regimen

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