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This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations.

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title	Report 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 brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included. For ease of reference in the table below, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA). For brevity, only the four bolded sets are represented in the following example datasets.

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This example Trial Summary (TS) dataset, shows many informational fields that provide context at the study level.

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 study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	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).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Bacterial Reverse Mutation Assay.
Rows 19-27:	Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this study.
Rows 28-30:	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.

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	8325064	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	8325064	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	8325064	TS	1		GLPFL	GLP Flag	N
4	8325064	TS	1		STSTDTC	Study Start Date	2015-07-29
5	8325064	TS	1		STITLE	Study Title	The Bacterial Reverse Mutation Test, Study 8325064-1
6	8325064	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	8325064	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	8325064	TS	1		APPLCNT	Applicant	Example Applicant Inc.
9	8325064	TS	1		APREFID	Applicant's Study Reference ID		NOT APPLICABLE
10	8325064	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
11	8325064	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
12	8325064	TS	1	1	TFCNTRY	Test Facility Country	USA
13	8325064	TS	1	1	STDIR	Study Director	Dr. R. Smith
14	8325064	TS	1	4	TSTGDNAM	Testing Guideline Name	Test NO. 471
15	8325064	TS	1	4	TSTGDORG	Testing Guideline Organization	OECD
16	8325064	TS	1	4	TSTGDVER	Testing Guideline Version	2020-06-29
17	8325064	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	8325064	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	AMES
19	8325064	TS	1	2	SPECIES	Species	SALMONELLA TYPHIMURIUM
20	8325064	TS	1	2	STRAIN	Strain/Substrain	TA98
21	8325064	TS	2	2	STRAIN	Strain/Substrain	TA100
22	8325064	TS	3	2	STRAIN	Strain/Substrain	TA1535
23	8325064	TS	4	2	STRAIN	Strain/Substrain	TA1537
24	8325064	TS	1	2	CELLLN	Cell Line	TA 98 hisD3052; rfa-; uvrB-
25	8325064	TS	2	2	CELLLN	Cell Line	TA 100 hisG46; rfa-; uvrB-
26	8325064	TS	3	2	CELLLN	Cell Line	TA 1535 hisG46; rfa-; uvrB-
27	8325064	TS	4	2	CELLLN	Cell Line	TA 1537 hisC3076; rfa-; uvrB-
28	8325064	TS	2	3	SPECIES	Species	ESCHERICHIA COLI
29	8325064	TS	5	3	STRAIN	Strain/Substrain	WP2 uvrA pKM101
30	8325064	TS	5	3	CELLLN	Cell Line	trpE uvrA

This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. A fully formed TX dataset for this example study would include information about the test conditions for all sets.

Note that there are three trial set parameters that link to other important datasets: SPTOBID, APDEVID, and SMKRGM.

SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID (e.g., CIG01a) matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).
The value of APDEVID (e.g., PUFFMASTER3K) matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
SMKRGM serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of SMKRGM indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2.

Dataset wrap

Name	tx

Rowcaps

Rows 1-22:	Show trial set parameters and trial set values that are the test conditions specific to set SetA which is the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 23-44:	Show trial set parameters and trial set values that comprise the test conditions for the set SetF which is the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.
Rows 45-66:	Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 67-88:	Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.

Dataset2

How do we handle "toxic, no revertant colonies"? (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)

populate units of COLONIES
recreate the data table - clean up, add "S" to the first set A
move assumptions out of all of the examples
add row captions to highlight exceptions/assumptions

This is an example showing trial design and results from the in vitro bacterial reverse mutation test of Study #8325064. The bacterial reverse mutation test uses four different amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and one strain of Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the S typhimurium and E. coli tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.

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title	ts.xpt (trial summary, study level parameters)

Assumption: When the experimental unit is derived from the species and strain, such as a cell line, then TESTSYS should be supplied.

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STUDYID

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TSSEQ

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TSGRPID

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TSPARMCD

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TSPARM

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TSVAL

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TSVALNF

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The Bacterial Reverse Mutation Test, Study 8325064-1

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title	Raw Data Table for Study 8325064

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Dataset wrap

Name	tx.xpt Trial Sets

Rowcaps
Rows 1-22:	Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the first row of the raw data table, see the row labeled "SetA" in the table, Raw Data for Study 8325064.
Rows 2-4:	Show two records for Alkaline Phosphatase that were collected 1 day apart and are expected to be reported together. Row 4 shows how to create a derived record (average of the Rows 2 and 3) and flag it as Derived (LBDRVFL = "Y") as well as the record to use as baseline (LBBLFL = "Y").
Rows 6-7:	Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (e.g., "DIFFERENTIAL").
Row 13:	Shows the use of LBUSCHFL to indicate that the test result was obtained from an unscheduled blood collection. In this case, the subject was moribund and a blood sample was taken prior to sacrifice.
Rows 1, 6:	Use records in the SUPPLB dataset example to show biological significance assigned by the investigator for test results.
Dataset2


Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetA	A-TA98-C0	1	SPECIES	Species	Salmonella typhimurium
2	8325064	Ames	TX	SetA	A-TA98-C0	2	STRAIN	Strain/Substrain	TA98
3	8325064	Ames	TX	SetA	A-TA98-C0	3	METACT	Metabolic Activation
4	8325064	Ames	TX	SetA	A-TA98-C0	4	METACTFL	Y/N presence of metabolic activation	N
5	8325064	Ames	TX	SetA	A-TA98-C0	5	TRTDMIN	Treatment Duration Minimum	71.5
6	8325064	Ames	TX	SetA	A-TA98-C0	6	TRTDTRG	Treatment Duration Target	72
7	8325064	Ames	TX	SetA	A-TA98-C0	7	TRTDMAX	Treatment Duration Maximum	72.5
8	8325064	Ames	TX	SetA	A-TA98-C0	8	TRTDU	Treatment Duration Unit	HOURS
9	8325064	Ames	TX	SetA	A-TA98-C0	9	INCBTMP	Incubation Temperature	37
10	8325064	Ames	TX	SetA	A-TA98-C0	10	INCBTMPU	Incubation Temperature Unit	C
11	8325064	Ames	TX	SetA	A-TA98-C0	11	HUMID	Atmospheric Relative Humidity Percent	50
12	8325064	Ames	TX	SetA	A-TA98-C0	12	ATMCO2	Atmospheric CO2 Percent	5
13	8325064	Ames	TX	SetA	A-TA98-C0	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
14	8325064	Ames	TX	SetA	A-TA98-C0	14	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
15	8325064	Ames	TX	SetA	A-TA98-C0	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
16	8325064	Ames

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064

TX

SetA

A-TA98-C0

16

1

INTRVN

name of the intervention article

TA1

SPECIES	Species	SALMONELLA TYPHIMURIUM
2

17

8325064

Ames

TX

SetA

A-TA98-C0

17

2

ITVTYPE

type of intervention article

Vehicle Control

IVTDMIN	In vitro Treatment Duration Minimum	71.5
3

18

8325064

Ames

TX

SetA

A-TA98-C0

18

3

ITVCONCConcentration of intervention article0

IVTDTRG	In vitro Treatment Duration Target	72
4

19

8325064

Ames

TX

SetA

A-TA98-C0

19

4

ITVCONCUConcentration Unitug/plate

IVTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064

208325064Ames

TX

SetA

A-TA98-C0

20

5

TRTV

IVTDU

In vitro Treatment

Vehicle

Duration Unit

DMSO

HOURS

21

6

8325064

Ames

TX

SetA

A-TA98-C0

21

6

SPDEVIDSponsor defined device identifierPUFFMASTER3K

INCBTMP	Incubation Temperature	37
7

22

8325064

Ames

TX

SetA

A-TA98-C0

22

7

DUREFIDSmoke RegimenMedium Intensity Regimen

INCBTMPU	Incubation Temperature Unit	C
8

23

8325064

Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

8

1SPECIESSpecies

ATMRHP	Atmospheric Relative Humidity Percent	50
9

24

8325064

Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

9

2

ATMCO2P

STRAINStrain/Substrain

Atmospheric CO2 Percent	5
10

25

8325064

Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

10

3METACTMetabolic Activation 268325064

SPTOBID	Applicant-defined tobacco identifier	CIG01a
11	8325064

Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

4

11

METACTFLY/N presence of metabolic activationN

EXPTYP	Exposure Type	Submerged
12	8325064

278325064Ames

TX

SetF

SetA

F

A-TA98-

C500TRTDRTOLTreatment Duration Tolerance

C0	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13

28

8325064

Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

13	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
14	8325064

8325064Ames

TX

SetF

SetA

F

A-TA98-

C500

C0

14

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

TA18325064AmesTXSetFF-TA98-C500ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Product8325064AmesTXSetFF-TA98-C500ITVCONCConcentration of intervention article5008325064AmesTXSetFF-TA98-C500ITVCONCUConcentration Unitug/plate8325064AmesTXSetFF-TA98-C500STRAINStrain/SubstrainTA988325064AmesTXSetFF-TA98-C500REGIMESmoking RegimeISO Regime...8325064AmesTX

SetG (row 7) do G not I!!!

METACTMetabolic Activation (should there be two parms? Presence, type)?None8325064AmesTXSetGTRTDRTRGTreatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetGTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetGTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetGINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine8325064AmesTXSetGITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Positive Control8325064AmesTXSetGITVCONCConcentration of intervention article58325064AmesTXSetGITVCONCUConcentration Unitug/plate8325064AmesTXSetGREGIMESmoking RegimeISO...SetG8325064AmesTX

SetR

(Row 18)

METACTMetabolic Activation (should there be two parms? Presence, type)?None8325064AmesTX

SetR

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetRTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetRTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetRINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

4-Nitroquinoline-1-oxide8325064AmesTXSetRITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Positive Control8325064AmesTXSetRITVCONCConcentration of intervention article28325064AmesTXSetRITVCONCUConcentration Unitug/plate8325064AmesTXSetRSTRAINStrain/SubstrainTA988325064AmesTXSetRREGIMESmoking RegimeISO

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