STDM generation in Lundbeck - From Source to Target

AgendaBackgroundArchitecture & ToolsDesign and Implementation of the SDTM conversion frameworkEvaluationPlan for further delvelopementQuestions/Discussion

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.

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

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

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

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

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)

Architecture

TARGET

Design and ImplementationThe shortest distance between two points is a stright line:

A

B

Design and ImplementationDivide the line into stages:

SOURCE

TARGETStage 1Stage 2Stage 3Stage 4

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

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

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

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)

Design and ImplementationDepictured with work-demanded proportions:

SOURCE

TARGETStage 1Stage 2Stage 3Stage 4DefineApplyDeriveStructure

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

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)

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

Thanks to H. Lundbeck A/SNordic CIDSC User Group Danish Association for Data Managers

Questions/Discussion

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