How to improve quality control in a data conversion process? By extended usage of metadata! Dimitri Kutsenko Entimo AG - Berlin/Germany Data Conversion Process SDTM Example Generic view SOURCE ALGORITHMS TARGET CHECKS PROCESS Define Dataset Structure Core process Annotate CRF Define Mapping © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com Generate and Run Mapping Program Perform SDTM Checks 19-Oct-2010 Generate Define 2 Cost of Change Curve Early QC Paradigm QC Tasks © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 3 Maintain Standards Library §  Invest effort into standards definition! §  Metadata Types Maintain Standards Library §  Dataset descriptions (industry or company domains) §  Conversion algorithms (text and code) §  Mappings §  Terminology… §  Challenges §  §  §  §  Global, project, trial and study levels Multiple standards / versions Interlinked dimensions Reusability Define Dataset Structure Annotate CRF Define Mapping Generate and Run Mapping Program Perform SDTM Checks Generate Define.xml Analysis of cross-level and cross-study dependencies required! © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 4 Standards Metadata Profiling §  Compare metadata domain definitions §  Detect and review discrepancies as early as possible! Data Profiling Metadata Metadata AE Domain (Global) AE Domain (Study) © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 46 1 1.77 24.5 44 0 1.62 30.2 46 0 1.66 33.1 62 1 1.80 21.9 19-Oct-2010 5 Standards Impact Analysis §  Track deviations between (changed) standards and related targets! §  Analysis/update shall include impact on datasets linked to standards §  Versioning/audit trail required for updates Metadata Common (Global) Metadata AE Domain (Study) © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com Data AE Dataset 19-Oct-2010 6 Define Metametadata Define Dataset Structures §  Define Metametadata (description of dataset metadata): §  Columns §  Formats to support checks Maintain Standards Library Define Dataset Structure §  Configuration rules for metadata Annotate CRF §  Rule examples: CDISC type – character, mandatory seq – integer, unique, starts with 1 §  Define Dataset Structures: Define Mapping Generate and Run Mapping Program Perform SDTM Checks §  Use metadata domain templates §  Derive from datasets, metametadata © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com Define Metametadata 19-Oct-2010 Generate Define.xml 7 Define Mapping §  Challenges: Define Metametadata §  Repeated algorithms §  Scarce experts §  Redundancy Maintain Standards Library §  Exploit standards at maximum! §  Standard metadata (domains) §  Standard conversion algorithms §  Standard mappings Define Dataset Structure Create aCRF Define Mapping Generate and Run Mapping Program §  Quality checks in the mapping Perform SDTM Checks definition: §  Consistency checks §  Review can be done Generate Define.xml language-independent © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 8 Perform SDTM Checks §  Integrate checks into conversion workflow! (incl. tracing) §  Flexible definition of check criteria required: §  Standard SDTM conformance checks §  Customer checks Source Data Source Checks Executable Program SDTM Data Maintain Standards Library Define Dataset Structure Create aCRF Define Mapping §  Checks from the 1st domain on! Mapping Program Define Metametadata Generate and Run Mapping Program Perform SDTM Checks Target Checks Generate Define.xml Check Report © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com Check Report 19-Oct-2010 9 Generate Define Structural Checks §  Metadata driven, Metadata Driven Process template based definition §  Check of data vs. metadata prior to: TARGET METADATA Mapping Specs §  Import/production Mapping Programs Target Data §  Define creation Define (xml) Structure Check Define Metametadata Maintain Standards Library Conservative Process TARGET METADATA Mapping Specs Mapping Programs Target Data Define Dataset Structure Create aCRF Define (xml) Define Mapping Generate and Run Mapping Program Perform SDTM Checks Generate Define.xml © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 10 Metadata Challenges §  Model related challenges: §  Metadata variation vs. metadata inflation §  Interlinked dimensions §  Automatic collection and processing §  Organization related challenges: §  Effort for standard development §  Consistent metadata management §  Model independence §  Different business processes §  Regulatory requirements © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 11 Metadata Based Data Conversion Process §  Metadata QC leveraged by smart tools/systems help you: §  §  §  §  §  Increase data quality and consistency Reduce cost of errors Flexibly support available and future standards Increase reusability of process components Set up controlled and traceable process © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 12 END Many thanks for your attention! Questions…? VISION STARTS NOW! Visit at entimo s booth or email to dku[at]entimo.de © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com 19-Oct-2010 13