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  • red font - indicates potential for CT code lists
  • green font - links to other domains
  • purple font - questions yet to be resolved 
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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)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123

ALL

TS1
GLPTYPGood Laboratory Practice TypeFDA
11123ALLTS1
STSTDTCStudy Start Date2007-12-30
13123ALLTS1
STITLEStudy TitleExample of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14123ALLTS1
SNDIGVERSEND Implementation Guide VersionTobacco IMPLEMENTATION GUIDE VERSION 1.0
15123

ALL

TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-03-26
17123ALLTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
18123ALLTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
19123ALLTS11TSTFNAMTest Facility NameExample Tox Lab Name
20123

ALL

TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
21123ALLTS11TFCNTRYTest Facility CountryUSA
24123ALLTS11STDIRStudy DirectorDr. R. Smith
28123ALLTS1
GLPFLGLP FlagY
29123MNvitTS1
ASTDAssay StandardOECD Test No. 487 
30123MNvitTS1
ASTDVAssay Standard Version2016-07-29
31123MNvitTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
32123MNvitTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus
33123MNvitTS1
SPECIESSpeciesHomo Sapiens
34123MNvitTS1
??Test System?TK6 Lymphoblastoid Suspension Cells
35123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519
36123NRUTS1
ASTDVAssay Standard Version2006-11
37123NRUTS1
SSTYPStudy Type

38123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake
39123NRUTS1
SPECIESSpeciesHomo Sapiens

40

123NRUTS1
??Test System??Normal Human Keratinocyte

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