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PharmaSUGOsaka2023
AutomaticGenerationofPythonProgramsforCreatingSDTMDatasets
FUJITSULIMITED
?2023FujitsuLimited.
PAGE
2
?2023FujitsuLimited.
Disclaimer
Theviewsandopinionsexpressedinthispresentationarethoseoftheauthor(s)anddonotnecessarilyreflecttheofficialpolicyorpositionoftheorganizationwheretheauthorbelongs.
AboutThisPresentation
ThemaintopicofthispresentationisautomaticgenerationofPython
programsforcreatingCDISCSDTMdatasets.
Beforedivingintothemaintopic,thispresentationwillexplain:
WhyPythonisagoodoptionfordatascienceindrugdevelopment
HowprogrammingpracticeischangingwithGenerativeAI
HowDigitalDataFlowisimpactingapproachtodataprocessing
BackgroundandTrends
4 ?2023FujitsuLimited.
PAGE
12
?2023FujitsuLimited.
PopularityofSAS,RandPython
Astudyconductedin2020for1,000datascientistsintheUnitedStatesshowedthatPython
wasthemostpopularlanguageamongSAS,RandPython,inanyindustry.
ItalsoshowsthatPythonismorepopularinyoungergeneration(withlessyearsofexperienceindatascience).
Reference:BurtchWorksLLC"
2020SAS,R,orPythonSurveyResults:WhichTooldoDataScientists&AnalyticsProsPrefer?
"
GenerativeAI
GenerativeAI(morepreciselyLLM:LargeLanguageModel)issignificantlychangingthewayhowprogramsaredeveloped.
CodeGeneration
CodeCompletion
TestCodeGenerationandmore
ChatGPT,themostfamousLLM-basedgenerativeAI,isbuiltwithPythonandbestatgeneratingPythoncodesamongotherlanguages.
AnotherfamousLLM-basedgenerativeAI,Copilot,istrainedonalllanguagesthatappearinpublicrepositories(seethetop50pullrequestsinQ3of2023ontheleft).
AdvancedDataAnalytics
AdvanceddataanalysisisanotherpowerfulfeatureofChatGPTthatallowsuploadingfiles,
writeandexecutePythoncodes,andcreategraphswithinstructionsinnaturallanguage.
DigitalDataFlow(DDF)Overview
DigitalDataFlow(DDF)isaninitiativebyTransCeleratethataimstocreatedigitizedstudy
protocolandautomatecreationofstudyassets.
Studybuildersordigitalprotocolauthoringtools
Centralrepositoryofdigitizedstudyprotocol
Automatedownstreamdocumentsandsystems
CDISCiscollaboratingwithTransCeleratetodevelopastandardmodelforStudyDefinitionsRepositoryaspartoftheirjourneytoachieveend-to-endautomation.
Note:ThecontentinthisslidehasbeencreatedbysummarizingcontentsontheTransCeleratewebsiteattheauthor’sowndiscretion.
DDFAchievesMoreSDTMAutomation
(2)ActivitieswithBCsaremappedtoformswhenadrafteCRFSpeciscreatedfromSDR.
(3)ActivitieswithBCsaremappedtoSDTMdomainswhenadraftSDTMSpeciscreatedfromSDR.
(1)Activities/BCsarepopulatedviaStudyBuilderorreadfromStudyProtocol.
StudyBuilder
Protocol
SDR
eCRFSpec SDTMSpec
BCs
BCs
AutomatedMapping
Generate
SDTM
Datasets
SDTM
BiomedicalConcepts(BC)
(4)SDRknowswhichBCsare
referencedfromwhichforms/domains
DigitalDataFlow
MetadataRepository
DDFandGenerativeAI
Dotheyconflictorcomplementtoeachother?
DigitalDataFlow
Protocol CRFSpec
SDTMSpec
SDTMDatasets
StatisticalAnalysisPlan
MockShells
ADaMSpec ADaMDatasets TLFs StudyReport
CDISCOak–SDTMAutomationinR
Awell-knownexampleofR-basedSDTMautomation
OnlyasAlgorithms
OnlyasSub-Algorithms
Algorithm&Sub-Algorithms
03_AE_AEREL
11_MERGE
01_ASSIGN_NO_CT
07_DATASET_LEVEL
18_REMOVE_DUP
02_ASSIGN_CT
09_IF_THEN_ELSE
19_GROUP_BY
05_HARDCODE_CT
17_WHODRUG_FA
20_NEED_USER_INPUT
06_HARDCODE_NO_CT
13_RELREC
08_NOTSUBMITTED
14_RELREC_CONDITION
15_MULTIPLE_RESPONSES
21_NONCRF_LAB
22_NONCRF_PKC
23_PAIRED_VARS
Upto22ReusableAlgorithms
Reference:F.Hoffmann-LaRocheAG"
OAKGarden-SDTMAutomationTheflourishingDataTransformationEngine
"
FujitsutsClinicalforSDTMAutomation
CRFandeDTSpecs
SDTMSpec
StandardsandTerminologies
TrialDesign
SimilarcomponentsandprocessestoOAKGarden,butmorevarietyofmethods.
MetadataRepository
TransformationEngine
RunsonOracleand.NET
AnnotatedCRF
BiomedicalConcepts
SDTM
Datasets
Transformation
Engine
SDTMSpec
(Executable)
Define-XML
TopicMethods
assignTopiccopycopyDesigncopyUniqueextrtjoinUniquelookupConcept
lookupConceptNormalizedlookupDomainREGEXn1mapTopic
se
sv
Non-TopicMethods
blflcalccoeval
commentconcatconcatDateconvertToStdcopycopyDesigncopyIfcopyToSUPP
…andmore
55Methodsand286UseCases**
**:Pre-configuredmethodcalls
AddingPythonImplementationtotsClinical
The55methodsarebeingimplementedinPython.
MetadataRepository
TransformationEngine
RunsonOracleand.NET
AnnotatedCRF
TransformationinPython
BiomedicalConcepts
SDTM
Datasets
Transformation
Engine
SDTMSpec
(Executable)
Define-XML
CRFandeDTSpecs
SDTMSpec
StandardsandTerminologies
TrialDesign
Pythoncurrentlyimplementedforreal-timemappingreviewasSDTMspecisedited.
Summary
GenerativeAIismultipurpose,andthusyourideasmattertomakeitvaluable.
PythonsitsinauniquepositionintheAIera.
DigitalDataFlowisbuiltonCDISCstandardsandhasgoodfamiliaritywithdataprocessing.
Afterall,therearemanychancesofautomationinyourjobwiththe
riseofLLM-basedgenerativeAIandDigitalDataFlow.
Exercise
CRFandeDTSpecs
SDTMSpec
StandardsandTerminologies
TrialDesign
Whichpartoftheprocessbe
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