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titlets.xpt (trial summary, study level parameters)
  • 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)
OECD Test No. 487 2016-07-29

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123ALLNRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123ALLNRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123ALLNRUTS1
STSTDTCStudy Start Date2022-05-25
4123ALLNRUTS1
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


5123ALLNRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123ALLNRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123ALLNRUTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123ALLNRUTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123ALLNRUTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123ALLNRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123ALLNRUTS11TFCNTRYTest Facility CountryUSA
...123ALL

NRU

TS11STDIRStudy DirectorDr. R. Smith

123ALLNRUTS1
GLPFLGLP FlagY123MNvitTS1ASTDAssay Standard

123MNvitTS1ASTDVAssay Standard Version123MNvitTS1SSTYPStudy TypeGENOTOXICITY IN VITRO123MNvitTS1SSSTYPStudy Sub TypeIn Vitro Micronucleus123MNvitTS1SPECIESSpeciesHomo Sapiens123MNvitTS1??Test System?TK6 Lymphoblastoid Suspension Cells123NRUTS1
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

123NRU
TS1
REPNUMReplicate Number1

...

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titlegt.xpt (similar to LB)

2022-05-25
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
0.7801123MNvitGTA21RICCRelative Increase in Cell Count13415.7%15.715.7%2022-05-252123MNvitGTA22RCCRelative Cell Count13413.0%13.013.0%2022-05-253123MNvitGTA23RPDRelative Population Doubling1347.9%7.97.9%2022-05-254123MNvitGTA24MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-255123MNvitGTA25MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-256123MNvitGTA26MNCELLSMicronucleated Cells275813Cells1313Cells2022-05-257123MNvitGTA27MNCELLSMicronucleated Cells271421Cells2121Cells2022-05-258123MNvitGTA28AVGRELAverage Relative MN Frequency0.66%0.660.66%2022-05-259123MNvitGTA11RICCRelative Increase in Cell Count1540%00%2022-05-2510123MNvitGTA12RCCRelative Cell Count1540%00%2022-05-2511123MNvitGTA13RPDRelative Population Doubling1540%00%2022-05-2512123MNvitGTA14MNCELLSMicronucleated Cells326615Cells1515Cells2022-05-2513123MNvitGTA15MNCELLSMicronucleated Cells219013Cells1313Cells2022-05-2514123MNvitGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-2515123MNvitGTA17MNCELLSMicronucleated Cells271412Cells1212Cells2022-05-2516123MNvitGTA18AVGRELAverage Relative MN Frequency0.57%0.570.57%