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  • Assumption: Study can have more than one assay type
  • Assumption: ASSAYID value of ALL means it applies to all assays in the study
  • Replaced the ASSAYID values of MNT with MNvit (term used in OECD #487) - is this better?  This is not a controlled term so we can use anything but what we use in our IG examples are often used in industry implementations so we should use realistic and best practice values as much as possible. 
  • BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
  • Where is TK6 cell type?  is this test system (see below)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123NRUTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
...123

NRU

TS11STDIRStudy DirectorDr. R. Smith

123NRUTS1
GLPFLGLP FlagY

123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519

123NRUTS1
ASTDVAssay Standard Version2006-11

123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

123NRUTS1
SPECIESSpeciesSalmonella enterica 

123NRUTS1
STRAINStrain/SubstrainSalmonella enterica enterica

123NRUTS1
??Test System??Normal Human Keratinocyte

123NRUTS1
REGIMESmoking RegimeTraditional combustible 

123NRUTS1
RUNPRTrun-port number?? (always same for whole assay?)

1-1



123NRUTS1
SMPLIDSample ID030001

123NRUTS1
SMKFRCSmoke FractionA

123
TS1
REPNUMReplicate Number1
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL;  For now, we just include good example values based on our experience
  • TXPARMCD/TXPARM = TSPARMCD/TSPARM
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTX1-1-A
(plate-col-row in the 96-well plate)
CSC-10
(through SLS-200)

PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-ACSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-ACSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-ACSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-ACSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-ACSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-BCSC-10
PLATENUMPlate number1  
8123NRUTX1-1-BCSC-10
WELLNUMNumber representing the location of the well in the 96-well plate2-A 
9123NRUTX1-1-BCSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
10123NRUTX1-1-BCSC-10
ITVTYPEtype of intervention articlePRODUCT
11123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
12123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
...


...





123NRUTX1-10-HSLS-10
PLATENUMPlate number1  

123NRUTX1-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX1-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX1-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX1-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX1-10-HSLS-10
ITVCONCUintervention unitug/ml
...


...





123NRUTX2-10-HSLS-10
PLATENUMPlate number2

123NRUTX2-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate2-A 

123NRUTX2-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX2-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX2-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX2-10-HSLS-10
ITVCONCUintervention unitug/ml

RowSTUDYIDASSAYIDDOMAINTXCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTCGTNOMDYGTELTMGTTPTREF
1123NRUGT1-1-A1RELABSRelative Absorbance Reading
100ug/ml100100ug/ml



2123NRUGT1-1-B1RELABSRelative Absorbance Reading
107ug/ml100100ug/ml



3123NRUGT1-1-C1RELABSRelative Absorbance Reading
98.6ug/ml100100ug/ml



54123NRUGT1-1-D1RELABSRelative Absorbance Reading
94.9ug/ml100100ug/ml



6123NRUGT1-1-E1RELABSRelative Absorbance Reading
111







7123NRUGT1-1-F1RELABSRelative Absorbance Reading
96.9







8123NRUGT1-1-G1RELABSRelative Absorbance Reading
105







9123NRUGT1-1-H1RELABSRelative Absorbance Reading
95.2







10123NRUGT1-2-A1RELABSRelative Absorbance Reading

83.0









11123NRUGT1-2-B1RELABSRelative Absorbance Reading
77.7







...


...












80123NRUGT1-10-H1RELABSRelative Absorbance Reading
0.791







...


...












160123NRUGT2-10-H1RELABSRelative Absorbance Reading
0.780







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