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Comment: TOBA-665

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Rows 1-2:

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-366
since both GLP types apply for this  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=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).  

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

Rows 19, 25:

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-367

Show that this study includes 2 different species of bacteria.
Rows 18-23:Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains and the cell line that are tested in this  study.
Rows 2425-26:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-665

Dataset2
Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064AmesTS1
GLPTYPGood Laboratory Practice TypeFDA
28325064AmesTS2
GLPTYPGood Laboratory Practice TypeOECD
38325064AmesTS1
STSTDTCStudy Start Date2015-07-29
48325064AmesTS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


58325064AmesTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
68325064AmesTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
78325064AmesTS1
SAPPLCNTApplicant OrganizationExample Applicant Inc.
88325064AmesTS1
SPREFIDApplicant's Study Reference ID
NOT APPLICABLE
98325064AmesTS11TSTFNAMTest Facility NameExample Tox Lab Name
108325064AmesTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
118325064AmesTS11TFCNTRYTest Facility CountryUSA
128325064AmesTS11STDIRStudy DirectorDr. R. Smith
138325064AmesTS1
GLPFLGLP FlagN
148325064AmesTS14TSTGDNAMTesting Guideline NameTest NO. 471
158325064AmesTS14TSTGDORGTesting Guideline OrganizationOECD
168325064AmesTS14TSTGDVERTesting Guideline Version2020-06-29
178325064AmesTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
188325064AmesTS1
SSSTYPStudy Sub TypeBACTERIAL REVERSE MUTATION TEST
198325064AmesTS12

SPECIES

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-484

Species

SALMONELLA TYPHIMURIUM

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-123


208325064AmesTS12STRAINStrain/SubstrainTA98
218325064AmesTS12STRAINStrain/SubstrainTA100
228325064AmesTS12STRAINStrain/SubstrainTA1535
238325064AmesTS12STRAINStrain/SubstrainTA1537
248325064AmesTS12CELLLNCell Line

258325064AmesTS13SPECIESSpecies

Escherichia coli

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-482


268325064AmesTS13STRAINStrain/SubstrainWP2 uvrA pKM101
278325064AmesTS13CELLLNCell Line

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