This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
red font - indicates potential for CT code lists
green font - links to other domains
purple font - to be discussed
Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
Row
STUDYID
ASSAYID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
123
MNvit
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
123
MNvit
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
123
MNvit
TS
1
STSTDTC
Study Start Date
2022-05-25
4
123
MNvit
TS
1
STITLE
Study Title
Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
5
123
MNvit
TS
1
SNDIGVER
SEND Implementation Guide Version
TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6
123
MNvit
TS
1
SNDCTVER
SEND Controlled Terminology Version
SEND Terminology 2021-09-30
7
123
MNvit
TS
1
SSPONSOR
Sponsor Organization
Example Sponsor Inc.
8
123
MNvit
TS
1
SPREFID
Sponsor's Study Reference ID
NOT APPLICABLE
9
123
MNvit
TS
1
1
TSTFNAM
Test Facility Name
Example Tox Lab Name
10
123
MNvit
TS
1
1
TSTFLOC
Test Facility Location
10 Somewhere Street, Montgomery, AL 10000
11
123
MNvit
TS
1
1
TFCNTRY
Test Facility Country
USA
12
123
MNvit
TS
1
1
STDIR
Study Director
Dr. R. Smith
13
123
MNvit
TS
1
GLPFL
GLP Flag
Y
14
123
MNvit
TS
1
ASTD
Assay Standard
OECD Test No. 487
15
123
MNvit
TS
1
ASTDV
Assay Standard Version
2016-07-29
16
123
MNvit
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
17
123
MNvit
TS
1
SSSTYP
Study Sub Type
In Vitro Micronucleus
18
123
MNvit
TS
1
SPECIES
Species
Homo Sapiens
19
123
MNvit
TS
1
??
Test System?
TK6 Lymphoblastoid Suspension Cells
During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
Where is TK6 cell type? is this test system (see below)
needs to be allowed to vary down to the well level / result level
A1:
A2:
Row
STUDYID
ASSAYID
DOMAIN
SETCD
SET (what sponsor calls it)
TXSEQ
TXPARMCD
TXPARM
TXVAL
123
MNvit
TX
A1
(table 1, row 1, ST exposure with S9)
METACT
Metabolic Activation (should there be two parms? Presence, type)?
+S9
METACTFL
Y/N presence of metabolic activation
123
MNvit
TX
A1
TRTDRTRG
Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
3
123
MNvit
TX
A1
TRTDRTOL
Treatment Duration Tolerance
123
MNvit
TX
A1
TRTDURU
Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
H
123
MNvit
TX
A1
INTRVN
name of the intervention article
(Tobacco ProdA, Bleomycin or Cyclophosphamid A)
Tobacco ProdA
123
MNvit
TX
A1
ITVTYPE
type of intervention article
choices of values: product; negative control; positive control
Product
123
MNvit
TX
A1
ITVCONC
Concentration of intervention article
0
123
MNvit
TX
A1
ITVCONCU
Concentration Unit
ug/ml
123
MNvit
TX
A2
(table 1, row 2)
METACT
Metabolic Activation (should there be two parms? Presence, type)?
+S9
123
MNvit
TX
A2
TRTDRTRG
Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
3
123
MNvit
TX
A2
TRTDRTOL
Treatment Duration Tolerance
123
MNvit
TX
A2
TRTDURU
Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)