Presentation for the European Clinical Data Forum conference, 24 May, 2011. Describing the business problems and drivers behind the design of a ISO11179 based metadata registry for clinical data. And also introducing the features of the CRL application.

1. Designing & Launching the Clinical Reference Library Kerstin Forsberg Mike Combs AstraZeneca R&D, Sweden IBM Global Clinical Information Strategy Pharmaceutical Team [email_address] [email_address]

7. Data Warehouse Data Marts Observational Data Store Clinical Reference Library Standards Team maintain definitions in CRL Legacy Studies External Collaborators ODS provides a single data definition standard into which all new and historic data is loaded prior to extraction for various purposes Provides clear definition of ODS contents Provides electronic data definition to acquisitions applications With the use of Enrichment configurations observational data can be transformed to the standard Data Extraction Configurations help automate extraction to a required configuration Data Extract Data Extract Data Extraction Configurations help automate extraction to a required configuration. Multiple configurations can be held in CRL to allow for different extracts such as SDTM for FDA and CDISC ODM for transfer to a partner Loading of data checked using data acquisition configuration Clinical Studies CRL Drives the Automated Capture & Transformation of Data Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential

9. CONCEPT: This layer describes medical concepts; the different methods of measuring and fully representing the concepts and their equivalences; relationships between concepts; and their classification CONFIGURATION: This layer specifies the different data items (defined in the concept layer) that are used for a particular clinical trial, project or standard STRUCTURE: This layer describes the structure of the datasets and variables for a particular clinical trial, project or standard CRL Conceptual Model CRL stores and manages 3 levels of metadata describing clinical data and their use within trials Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential

10. CONCEPT: This layer describes medical concepts; the different methods of measuring and fully representing the concepts and their equivalences; relationships between concepts; and their classification CRL Conceptual Model The concept layer captures content in the library at the atomic level Observations - Real World Phenomenon - Observation Concept - Observation Type - Observation Qualifiers - Carrier of Topic - Classification Standards - Groups - Relationships Enrichment - Implicit Value - Uniformed Value Meaning Versions & Alternatives - Synonyms - Historical Linkage Data Element Concepts - Data Element Concept - Data Element - Conceptual Domain - Value Domain - Value Meaning - Unit of Measure - Permissible Value Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential

11. CRL Conceptual Model The configuration layer is where content from the library is collected and made available to external applications Configuration Components - Property Type - Observation Type - Subject Type - Arm, Subject, Site - Relationship - Group - Transposed Structure - Data Structure Type - Implicit Specification Configurations - Represent Existing Data - Extracts - Data Acquisition - Enrichments CONFIGURATION: This layer specifies the different data items (defined in the concept layer) that are used for a particular clinical trial, project or standard Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential

12. CRL Conceptual Model The structure layer defines the physical structure for variables and datasets within a study Data Structures Identifiers Transposed Structures STRUCTURE: This layer describes the structure of the datasets and variables for a particular clinical trial, project or standard Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential

13. CRL Has Been Built & Launched IBM has built and Launched version 1 of the CRL – offering the core components Designing & Launching the Clinical Reference Library | European Clinical Data Forum Mike Combs | May 2011 | IBM Confidential