The Test Data Factory Project
Working Group: Standard Analyses and Code Sharing Peter Schaefer
Validated Cloud Applications
TheTestDataFactoryProject
•  Background:
–  SeveralPhUSEprojects(specificallyintheWG
“StandardAnalysesandCodeSharing”)developscripts
orconceptsthatneedtobetestedwithtrialdatasets
–  PhUSEmembersworkonprojectstoimplementCDISCbasedsystemsorprocesses,frommappingraw
collectedstudydatatoADaM-baseddataanalysis,and
theyneedtotestthesesystemsandprocesses
–  UseofCDISCpilot(outdated)andsaniMzeddatasets
(fromteammembers)fortesMngisconsidered
unsystemaMcandnotsufficientinmanycases
TestDataFactoryProject:ThePlan
•  ApproachandObjecMve:
–  Determinetestdatasetrequirements(like#of
subjects,observaMonparameters,etc.)
–  Implementscriptsthatcreate‘simulated’study
data(rawdata,SDTM,and/orADaMdatasets
–  Publishdatasetsanduser-configurablescripts
TestDataFactoryProject:Scope
•  IncompletelistofopMons:
•  Collected“raw”studydatafortesMngorqualifyingmapping
processesfromcollecteddatatoSDTM
•  SDTMdatasetsfortesMng/qualifyingsystemsforSDTMtoADaM
mapping
•  TestdataforspecificPhUSE(orother)projects.Examplesare
–  ADVS,ADLBdatasetsforCentralTendencygroup
–  ADNCAdatasetstosupportreleaseofPKanalysisdatastandard.
•  End-toendsetofstudydatabasedondefinedversionofstandards
(similartoCDISC-Pilotdatasets)
–  CouldincludeCDASH,SDTM,ADaM,define.xml
•  …
TestDataFactoryProject:PoC
•  ProofofconceptusingRandVicos™
–  CreatedRscriptthatgeneratesDMdataset
–  UserinterfacetosetopMonslikenumberof
subjects,trialdesign,valuesforSEXandRACE,and
theformatoftheoutputfile(.xptor.csv)
–  GeneratesDMdatasetthatwillpassPinnacle21
validaMon(withoneexcepMoninthePoC
applicaMon)
StatusandNextSteps
•  Status:
–  Completedaproofofconcept
–  StartedtoworkonscopeandprioriMes,but…
–  NeedtorecruitadiMonalteammemberstomoveahead
•  GetmoreinformaMon:
–  Askpschaefer@vca-plus.com
–  Goto
hep://www.phusewiki.org/wiki/index.php?Mtle=WG5_Project_09
•  Signuptocontribute!