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Comment: moved the sentence introducing the TS dataset to be just before the TS dataset rather than just before the example report table

This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test

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using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations.
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 In this example, the Trial Summary (TS) dataset

Expand
titleReport Table for Example Study 8325064

This table shows the assay results for study 8325064, test article TA1, and 3 strains of salmonella (TA98, TA100, and TA1535) at varying concentrations. For ease of reference, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA).  For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included.

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506

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This example Trial Summary (TS) dataset

 includes many informational fields
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that may provide context at the study level.   
TOBA-481
,
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368
shows many informational fields
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titleReport Table for Example Study 8325064

369
that provide context at the study level.   

...

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664


Dataset wrap
Rowcaps
Rows 1-2:

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

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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).  

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Rows 19, 25:

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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 25-26:

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.

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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

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Species

SALMONELLA TYPHIMURIUM

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

258325064AmesTS13SPECIESSpecies

Escherichia coli

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268325064AmesTS13STRAINStrain/SubstrainWP2 uvrA pKM101
278325064AmesTS13CELLLNCell Line

...