STDM generation in Lundbeck - From Source to Target

1. STDM generation in Lundbeck - From Source to Target H. Lundbeck A/S15-Sep-141

2. Agenda • Background • Architecture & Tools • Design and Implementation of the SDTM conversion framework • Evaluation • Plan for further delvelopement • Questions/Discussion H. Lundbeck A/S15-Sep-142

3. Background • This is a presentation about: • The considerations and experiences Lundbeck has had when implementing their SDTM conversion process • This a not a presentation about • Hardcore SAS macros • A detailed explaination of the SDTM data model. H. Lundbeck A/S15-Sep-143

4. Background • The 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 H. Lundbeck A/S15-Sep-144

5. Background • The 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 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 H. Lundbeck A/S15-Sep-145

6. Background • Source data from four Rave studies were selected as the basis for the implementation of the framework • Lundbeck project LuAA21004, studies 11984A, 11984B and 11985A and Lundbeck project LuAA24530: study 11918A H. Lundbeck A/S15-Sep-146

7. Background • The experiences from converting the first four studies will lay the basis for a Lundbeck SDTM data model • Domain definitions of all domains currently used in the SDTM conversion process • Convension rules /Algorithms • CDISC/Lundbeck Controlled Terminology H. Lundbeck A/S15-Sep-147

8. Architecture • Available tools for the SDTM conversion: • Clinical study data (a lot!) • An ETL-tool for data manipulation • The SDTM Implementation Guidelines version 3.1.1/3.1.2 • CDISC Controlled Terminology • In-house experience of a previously SDTM conversion project (Gaboxadol) H. Lundbeck A/S15-Sep-148

9. SDTM Interface Rave Reporting Tool Datafax eDM/eDE ETL Tool SOURCE SAS-Di Studio CROs SADS Partners Architecture TARGET H. Lundbeck A/S15-Sep-149

10. Design and Implementation • The shortest distance between two points is a stright line: A B H. Lundbeck A/S15-Sep-1410

11. Design and Implementation • Divide the line into stages: SOURCE TARGET Stage 1 Stage 2 Stage 3 Stage 4 H. Lundbeck A/S15-Sep-1411

12. Design and Implementation • Stage 1(Define): • Define the mapping from source to target • Annotate CRF according to the SDTM format • Implement the mapping • Build up data dictionaries (SAS format libraries) Example H. Lundbeck A/S15-Sep-1412

13. Design and Implementation • Stage 2(Apply): • Apply the mappings to the source data • Apply the SAS user defined formats • Set the value of general variables • E.g. STUDYID, DOMAIN, VISIT, VISITNUM, VISITDY • A SAS macro library H. Lundbeck A/S15-Sep-1413

14. Design and Implementation • Stage 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 H. Lundbeck A/S15-Sep-1414

15. Design and Implementation • Stage 4(Structure): • Create the final structure on datasets • E.g. create the supplemental qualifiers domains. • Create the CO (Comments Domain) • Create the Trial Design Domains (TI, TE, TV,TS,TA) H. Lundbeck A/S15-Sep-1415

16. Design and Implementation • Depictured with work-demanded proportions: Derive Define Stage 3 SOURCE TARGET Stage 1 Stage 2 Stage 4 Apply Structure H. Lundbeck A/S15-Sep-1416

17. Evaluation • Evaluation 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 H. Lundbeck A/S15-Sep-1417

18. Further Development • Implement the WebSDTM validation checks • Development and implementation of a CDASH library • Greater transparency in the data flow • SDTM knowledge/experience sharing between companies (Network Groups) H. Lundbeck A/S15-Sep-1418

19. …and some memories ’Computer Charlie er en helt almindelig mand & han ta'r toget ind til City hver dag gemmer sit ansigt så godt han ka' bag et slør fra dagens første Havanna han ligner til forveksling alle andre i kupé'en der til gengæld ligner koksgrå lig & sidder pænt på række som på bunden af en grav mens station efter station bare suser forbi’ ’I en blågrå kupe’ af C.V. Jørgensen H. Lundbeck A/S15-Sep-1419

20. Thanks to … • H. Lundbeck A/S • Nordic CIDSC User Group • Danish Association for Data Managers H. Lundbeck A/S15-Sep-1420

21. Questions/Discussion ? H. Lundbeck A/S15-Sep-1421