Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 8:
Shows that the applicant's
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-356
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).
Dataset2
NIH
Row
STUDYID
GNTXAID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
123
NRU
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
123
NRU
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
123
NRU
TS
1
STSTDTC
Study Start Date
2022-05-25
4
123
NRU
TS
1
STITLE
Study Title
Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
5
123
NRU
TS
1
SNDIGVER
SEND Implementation Guide Version
TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6
123
NRU
TS
1
SNDCTVER
SEND Controlled Terminology Version
SEND Terminology 2021-09-30
7
123
NRU
TS
1
SAPPLCNT
Applicant Organization
Example Applicant Inc.
8
123
NRU
TS
1
SPREFID
Applicant Study Reference ID
NOT APPLICABLE
9
123
NRU
TS
1
1
TSTFNAM
Test Facility Name
Example Test Lab Name
10
123
NRU
TS
1
1
TSTFLOC
Test Facility Location
10 Somewhere Street, Montgomery, AL 10000
11
123
NRU
TS
1
1
TFCNTRY
Test Facility Country
USA
12
123
NRU
TS
1
1
STDIR
Study Director
Dr. R. Smith
13
123
NRU
TS
1
GLPFL
GLP Flag
Y
14
123
NRU
TS
1
ASTD
Assay Standard
4
TSTGDNAM
Testing Guideline Name
Publication No. 07-4519
15
123
NRU
TS
1
4
TSTGDORG
Testing Guideline Organization
NIH
16
123
NRU
TS
1
ASTDV
4
TSTGDVER
Testing Guideline
Assay Standard
Version
2006-11
16
17
123
NRU
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
17
18
123
NRU
TS
1
SSSTYP
Study Sub Type
In Vitro Neutral Red Uptake
18
19
123
NRU
TS
1
SPECIES
Species
Human
19
20
123
NRU
TS
1
CELLLN
Cell Line
NHK
Dataset wrap
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-279
Rowcaps
Rows 1-12:
Show the test conditions for the set with a short name or SETCD value of ALL. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-20:
Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row 20:
Shows the value for Cell Line, CELLLN, is NOT APPLICABLE because the well is a media only well, having no NHK cells.
Rows 21-28:
Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well number 2, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Rows 29-36:
Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110µg/mLof Sodium Laurel Sulfate as shown in the report table for study 123.