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titlets.xpt (trial summary, study level parameters)
  • 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

1123MNvitTS1
GLPTYPGood Laboratory Practice TypeFDA
2123MNvitTS2
GLPTYPGood Laboratory Practice TypeOECD
3123MNvitTS1
STSTDTCStudy Start Date2022-05-25
4123MNvitTS1
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


5123MNvitTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123MNvitTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123MNvitTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123MNvitTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123MNvitTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123MNvitTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123MNvitTS11TFCNTRYTest Facility CountryUSA
12123MNvitTS11STDIRStudy DirectorDr. R. Smith
13123MNvitTS1
GLPFLGLP FlagY
14123MNvitTS1
ASTDAssay StandardOECD Test No. 487 
15123MNvitTS1
ASTDVAssay Standard Version2016-07-29
16123MNvitTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17123MNvitTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus
18123MNvitTS1
SPECIESSpeciesHomo Sapiens
19123MNvitTS1
??Test System?TK6 Lymphoblastoid Suspension Cells

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