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move assumptions out of all of the examples
add row captions to highlight exceptions/assumptions

This is an example showing the report table, trial design, and results from the a study's in vitro bacterial reverse mutation test of Study #8325064. The bacterial reverse mutation test uses four using 4 different amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and one 1 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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Assumption: When the experimental unit is derived from the species and strain, such as a cell line, then TESTSYS should be supplied.

In this example, the Trial Summary dataset, ts.xpt, includes many informational fields that may provide context at the study level, for Study 8325064. Also, TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1) and records related to the Test Site (TSGRPID = 2). The Study Director is associated with the Test Facility and the Principal Investigator is associated with the Test Site. Finally, the Primary Treatment CAS Registry Number is not known and this is recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.

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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

Dataset wrap

Rowcaps

Rows 1-2:	Shows two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Rows 9-12:

TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID=1). The

Study Director

study director is associated with the

Test Facility

test facility.

Rows

18

14-

24

16:

Shows that this example study includes two different species of bacteria and a total of five strains.

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

Rows 18-22:Shows

that TSGRPID (TSGRPID = 2) has been used to link the information for

one

1 species (

Salmonella

salmonella) with

four

the 4 different strains and cell lines that are tested in

this example

this study.

Row 23

Rows 28-

24

30:

Shows

Show that TSGRPID (TSGRPID = 3) has been used to link the information for

one

1 species (

Escherichia

E. coli) with the strain and cell line that is tested in this

example

study.

	GNTXAID	Genetic Toxicology Assay Identifier	AMES
19

IVTDTRG	In vitro Treatment Duration Target	72
4	8325064

SPTOBID	Applicant-defined tobacco identifier	CIG01a
11

EXPTYP	Exposure Type	Submerged
12

SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064

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move assumptions out of all of the examples

add row captions to highlight exceptions/assumptions

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

ITVCONCU	Intervention Article Concentration Unit	%
22	8325064	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
23	8325064

	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
10	8325064

Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	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