Page History

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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 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.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-665

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 Organization	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.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-483

A fully formed TX dataset for this example study would include information about the test conditions for all sets.

...

Dataset wrap

Name	relref

Rowcaps

Row 1:

Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, DMSO.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-458

Rows 2-6:

Show the values of

Rows 2-6:

Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.

Row 7:

Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.

Rows 8-10:

Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.

Row 11:

Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.

Rows 12-14:

Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.

Row 15:

Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, NaN3.

Rows 16-18:

Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.

Dataset2

tableid	relref.xpt

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	8325064	SetA	A		1	EXPERIMENTAL UNIT/TRIAL SET
2	8325064	SetA	1_1	A	2	OBSERVATIONAL UNIT
3	8325064	SetA	1_2	A	2	OBSERVATIONAL UNIT
4	8325064	SetA	1_3	A	2	OBSERVATIONAL UNIT
5	8325064	SetA	1_4	A	2	OBSERVATIONAL UNIT
6	8325064	SetA	1_5	A	2	OBSERVATIONAL UNIT
7	8325064	SetF	F		1	EXPERIMENTAL UNIT/TRIAL SET
8	8325064	SetF	6_1	F	2	OBSERVATIONAL UNIT
9	8325064	SetF	6_2	F	2	OBSERVATIONAL UNIT
10	8325064	SetF	6_3	F	2	OBSERVATIONAL UNIT
11	8325064	SetG	G		1	EXPERIMENTAL UNIT/TRIAL SET
12	8325064	SetG	7_1	G	2	OBSERVATIONAL UNIT
13	8325064	SetG	7_2	G	2	OBSERVATIONAL UNIT
14	8325064	SetG	7_3	G	2	OBSERVATIONAL UNIT
15	8325064	SetR	R		1	EXPERIMENTAL UNIT/TRIAL SET
16	8325064	SetR	18_1	R	2	OBSERVATIONAL UNIT
17	8325064	SetR	18_2	R	2	OBSERVATIONAL UNIT
18	8325064	SetR	18_3	R	2	OBSERVATIONAL UNIT

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-454

Dataset wrap

Name	gt

Rowcaps

Rows 1-5:

Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset).

Rows 6, 7:

Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset.

Rows 8-13:

Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn).

Rows 14-16:

Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.

Rows 17-19:

Show 3 plates/observational units (GTREFID=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T".

Jira

showSummary	false
server	Issue Tracker (JIRA)
columnIds	issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columns	key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-668

Rows 20-22:

Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3).

Rows 23-25:

Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.

Dataset2

TOBA-487

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTORRES	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTAT	GTREASND	GTMETHOD	GTDTC
1	8325064	GT	1	1_1	RPP	Revertant Colony Numbers Per Plate	26		26	26
Jira
showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key				INSTRUMENT COUNTED	2015-08-03
2	8325064	GT	2	1_2	RPP	Revertant Colony Numbers Per Plate	35		35	35			INSTRUMENT COUNTED	2015-08-03
3	8325064	GT	3	1_3	RPP	Revertant Colony Numbers Per Plate	39		39	39			INSTRUMENT COUNTED	2015-08-03
4	8325064	GT	4	1_4	RPP	Revertant Colony Numbers Per Plate	35		35	35			INSTRUMENT COUNTED	2015-08-03
5	8325064	GT	5	1_5	RPP	Revertant Colony Numbers Per Plate	30		30	30			INSTRUMENT COUNTED	2015-08-03
6	8325064	GT	6	A	RPP	Revertant Colony Numbers Per Plate	33.0	MEAN	33.0	33.0				2015-08-03
7	8325064	GT	7	A	RPP	Revertant Colony Numbers Per Plate	5.0	STANDARD DEVIATION	5.0	5.0				2015-08-03
8	8325064	GT	8	6_1	RPP	Revertant Colony Numbers Per Plate	8		8	8			MANUALLY COUNTED	2015-08-03
9	8325064	GT	9	6_1	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn		V					2015-08-03
10	8325064	GT	10	6_2	RPP	Revertant Colony Numbers Per Plate	10		10	10			MANUALLY COUNTED	2015-08-03
11	8325064	GT	11	6_2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn		V					2015-08-03
12	8325064	GT	12	6_3	RPP	Revertant Colony Numbers Per Plate	12		12	12			MANUALLY COUNTED	2015-08-03
13	8325064	GT	13	6_3	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn		V					2015-08-03
14	8325064	GT	14	F	RPPMEAN	Mean Rev Colony Num Per Plate	10.0	MEAN	10.0	10.0				2015-08-03
15	8325064	GT	15	F	RPPSTDDV	Std Dev Rev Colony Num Per Plate	2.0	STANDARD DEVIATION	2.0	2.0				2015-08-03
16	8325064	GT	16	F	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	0.3	FOLD INCREASE	0.3	0.3				2015-08-03
17	8325064	GT	17	7_1	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies		T		NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	8325064	GT	18	7_2	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies		T		NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
19	8325064	GT	19	7_3	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies		T		NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
20	8325064	GT	20	18_1	RPP	Revertant Colony Numbers Per Plate	812		812	812			INSTRUMENT COUNTED	2015-08-03
21	8325064	GT	21	18_2	RPP	Revertant Colony Numbers Per Plate	912		912	912			INSTRUMENT COUNTED	2015-08-03
22	8325064	GT	22	18_3	RPP	Revertant Colony Numbers Per Plate	839		839	839			INSTRUMENT COUNTED	2015-08-03
23	8325064	GT	23	R	RPPMEAN	Mean Rev Colony Num Per Plate	854.3	MEAN	854.3	854.3				2015-08-03
24	8325064	GT	24	R	RPPSTDDV	Std Dev Rev Colony Num Per Plate	51.7	STANDARD DEVIATION	51.7	51.7				2015-08-03
25	8325064	GT	25	R	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	6.4	FOLD INCREASE	6.4	6.4				2015-08-03

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