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 sponsorapplicant's study 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.
Dataset2
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
SSPONSORSAPPLCNT
Sponsor Applicant Organization
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-356
Example Sponsor Applicant, Inc.
8
123
NRU
TS
1
SPREFID
Sponsor Study 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
OECD GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15
123
NRU
TS
1
ASTDV
Assay Standard Version
29-July-2016
16
123
NRU
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
17
123
NRU
TS
1
SSSTYP
Study Sub Type
MICRONUCLEUS TEST
18
123
NRU
TS
1
SPECIES
Species
HUMAN
19
123
NRU
TS
1
CELLLN
Cell Line
TK6 LYMPHOBLASTOID
...
Dataset wrap
Name
tx
Rowcaps
Rows 1-17:
Show the experimental parameters that are common for Table 1 of Study 123.
Rows 18, 25:
Show that set A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.
Rows 18-24:
Show trial set parameters and trial set values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".
Set A1 is associated with the first row in the sample report table for Study 123.
Rows 25-31:
Show trial set parameters and trial set values that comprise the test conditions for trial set A2. Set A2 is the data for the short term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".
Set A2 is associated with the second row in the sample report table for Study 123.