STDM generation in Lundbeck - From Source to Target
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Transcript of STDM generation in Lundbeck - From Source to Target
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STDM generation in Lundbeck - From Source to Target
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AgendaBackgroundArchitecture & ToolsDesign and Implementation of the SDTM conversion frameworkEvaluationPlan for further delvelopementQuestions/Discussion
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BackgroundThis is a presentation about:The considerations and experiences Lundbeck has had when implementing their SDTM conversion process
This a not a presentation aboutHardcore SAS macrosA detailed explaination of the SDTM data model.
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BackgroundThe SDTM conversion project was initated and developed in 2007-2008 as a part of the Lundbeck eClinical program.
Started with one programmer under the supervision of a project lead.
Current status: the SDTM conversion process is rolled out in Line of Business (the CDO Department) and involves five programmers and one project manager
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BackgroundThe goal was to implement a framework for converting any clinical study data (source) into an SDTM data format (target)
Benefits of framework: Extend the use of industry standards (CDISC/SDTM) to the clinical data process flowEliminate data transformation / alignment both within and across studies and from external sources Enable systematic and extensive use of current and historical data Simplify data interchange with partners and regulatory authorities
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BackgroundSource data from four Rave studies were selected as the basis for the implementation of the frameworkLundbeck project LuAA21004, studies 11984A, 11984B and 11985A and Lundbeck project LuAA24530: study 11918A
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BackgroundThe experiences from converting the first four studies will lay the basis for a Lundbeck SDTM data modelDomain definitions of all domains currently used in the SDTM conversion processConvension rules /AlgorithmsCDISC/Lundbeck Controlled Terminology
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ArchitectureAvailable tools for the SDTM conversion:Clinical study data (a lot!)An ETL-tool for data manipulationThe SDTM Implementation Guidelines version 3.1.1/3.1.2CDISC Controlled TerminologyIn-house experience of a previously SDTM conversion project (Gaboxadol)
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Architecture
TARGET
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Design and ImplementationThe shortest distance between two points is a stright line:
A
B
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Design and ImplementationDivide the line into stages:
SOURCE
TARGETStage 1Stage 2Stage 3Stage 4
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Design and ImplementationStage 1(Define):Define the mapping from source to targetAnnotate CRF according to the SDTM formatImplement the mappingBuild up data dictionaries (SAS format libraries)
Example
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Design and ImplementationStage 2(Apply):Apply the mappings to the source dataApply the SAS user defined formatsSet the value of general variablesE.g. STUDYID, DOMAIN, VISIT, VISITNUM, VISITDYA SAS macro library
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Design and ImplementationStage 3(Derive):Derive standard values based on the original collected result(Relevant for the Findings Observation Class).E.g. the variables --STRESC and STRESN and standard units in STRESU
Derive other values.E.g. the variables --DY, VSTESTCD=BMI, --SEQ
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Design and ImplementationStage 4(Structure):Create the final structure on datasetsE.g. create the supplemental qualifiers domains.
Create the CO (Comments Domain)
Create the Trial Design Domains (TI, TE, TV,TS,TA)
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Design and ImplementationDepictured with work-demanded proportions:
SOURCE
TARGETStage 1Stage 2Stage 3Stage 4DefineApplyDeriveStructure
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EvaluationEvaluation of the benefits:Extend the use of industry standards (CDISC/SDTM) to the clinical data process flow Eliminate data transformation / alignment both within and across studies and from external sources Enable systematic and extensive use of current and historical data Simplify data interchange with partners and regulatory authorities
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Further DevelopmentImplement the WebSDTM validation checks Development and implementation of a CDASH libraryGreater transparency in the data flowSDTM knowledge/experience sharing between companies (Network Groups)
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and some memories
Computer Charlieer en helt almindelig mand& han ta'r toget ind til City hver daggemmer sit ansigt s godt han ka'bag et slr fra dagens frste Havannahan ligner til forveksling alle andre i kup'ender til gengld ligner koksgr lig& sidder pnt p rkke som p bunden af en gravmens station efter station bare suser forbi
I en blgr kupe af C.V. Jrgensen
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Thanks to H. Lundbeck A/SNordic CIDSC User Group Danish Association for Data Managers
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Questions/Discussion
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