1. H. Lundbeck A/S16-Jan-141 STDM generation in Lundbeck - From Source to Target

2. H. Lundbeck A/S16-Jan-142 Agenda Background Architecture & Tools Design and Implementation of the SDTM conversion framework Evaluation Plan for further delvelopement Questions/Discussion

3. H. Lundbeck A/S16-Jan-143 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.

4. H. Lundbeck A/S16-Jan-144 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

5. H. Lundbeck A/S16-Jan-145 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

6. H. Lundbeck A/S16-Jan-146 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

7. H. Lundbeck A/S16-Jan-147 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

8. H. Lundbeck A/S16-Jan-148 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)

9. H. Lundbeck A/S16-Jan-149 Architecture Rave Datafax eDM/eDE Partners CROs ETL Tool SDTM Interface Repor ting Tool SADS SOURCETARGET SAS-Di Studio

10. H. Lundbeck A/S16-Jan-1410 Design and Implementation The shortest distance between two points is a stright line: A B

11. H. Lundbeck A/S16-Jan-1411 Design and Implementation Divide the line into stages: SOURCE TARGET Stage 1Stage 2Stage 3Stage 4

12. H. Lundbeck A/S16-Jan-1412 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

13. H. Lundbeck A/S16-Jan-1413 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

14. H. Lundbeck A/S16-Jan-1414 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

15. H. Lundbeck A/S16-Jan-1415 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)

16. H. Lundbeck A/S16-Jan-1416 Design and Implementation Depictured with work-demanded proportions: SOURCE TARGET Stage 1 Stage 2 Stage 3 Stage 4 Define Apply Derive Structure

17. H. Lundbeck A/S16-Jan-1417 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

18. H. Lundbeck A/S16-Jan-1418 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)

19. H. Lundbeck A/S16-Jan-1419 …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

20. H. Lundbeck A/S16-Jan-1420 Thanks to … H. Lundbeck A/S Nordic CIDSC User Group Danish Association for Data Managers

21. H. Lundbeck A/S16-Jan-1421 Questions/Discussion ?