1. ® Cancer Data Standards Repository (caDSR) in the Context of Clinical Trials How is caDSR helping CCR collect and report clinical trials data? The case of the Central Cancer Clinical Database (C3D) How is caDSR helping CCR collect and report clinical trials data? The case of the Central Cancer Clinical Database (C3D) NCICB Jamboree February 26, 2003 or

2. ® Agenda: caDSR in Clinical Trials caDSR Tools caDSR Data Model Implementing CDEs in Clinical Central Cancer Clinical Database (C3D) –RDC –Discoverer caDSR Tools caDSR Data Model Implementing CDEs in Clinical Central Cancer Clinical Database (C3D) –RDC –Discoverer

3. ® caDSR Tools CRT CRFs Questions Valid Values Web Interface PL/SQL Web Toolkit 9i Application Server AC-centric Web Interface Java Tomcat Web Interface Java 9i Application Server DE–centric XML / Excel Download Web Interface Java 9i Application Server DE-centric CDE Curation CDE Browser Client/Server Excel/VB/PL/SQL DE-centric CRF questions Client/Server Excel/VB/PL/SQL CRF-centric Oracle caDSR Database Web Interface Java Tomcat R R R R CRUD R C CUD Client/Server Java AC-centric XML Loader C 1 2 6 5 3 4 7 8 9 10 11 12 R CRF questions / DE caDSR CRF Loader EVS CCRR CRF questions / DE Matches

4. ® caDSR Core Model

5. ® Property Context Representation Data Element Concept Conceptual Domain Permissible Values Value Domain caDSR Core Model (Abbreviated) Value Meanings Administered Component Administered Component To Be List of Values Data Element Object Class

6. ® C3D – Built around Oracle Clinical Clinical research system for pharmaceutical industry Supports any kind of study in all therapeutic areas Expedites the regulatory approval process by reducing cycle times Four subsystems –Study design and management –Study data definition –Data capture and validation –Access and reporting Clinical research system for pharmaceutical industry Supports any kind of study in all therapeutic areas Expedites the regulatory approval process by reducing cycle times Four subsystems –Study design and management –Study data definition –Data capture and validation –Access and reporting

7. ® Loading CDEs into Oracle Clinical Oracle Clinical Maintain GLIB Elements Oracle Clinical Repository Global Library Elements Web Browser caDSR Repository Manual Extract Program MSExcel (.xls) Spreadsheet SQL*Loader Tables: Nci_cde Nci_cde_dvg Nci_cde_dvg_values Nci_cde_questions Nci_cde_question_cat_rel Pgms: Cde2dvgs Cde2dvg_values Cde2questions Tables: Discrete_value_groups Discrete_values Questions Question_Category_Relations Oracle RDBMS PL/SQL programs

8. ® Loading CDEs into Oracle Clinical (detail) caDSR Repository Manual Extract Program MSExcel (.xls) Spreadsheet NCI_CDE SQL*Loader Cde2dvgs.mig_data Cde2questions.get_data Oracle Clinical Cde2dvg_values. mig_data Cde2questions. mig_data Cde2dvgs.get_data Cde2dvg_values.get_data Nci_cde_dvgNci_cde_dvg_valuesNci_cde_questionsNci_cde_question_cat_rel Discrete_Value_ Groups Discrete_Values Questions Question_ Category_ Relations Derive_cde.sql

9. ® caDSR mapping to Oracle Clinical

10. ® caDSR mapping to Oracle Clinical (2)

11. ® Review, Modify and Activate DVG

12. ® Refine Question Definitions as needed

13. ® C3D Vision Oracle Clinical Repository Global Library Elements RDC – Internet Explorer CRF Entry Discrepancy Mngt Monitors CTMS CDUS Discoverer Data Entry Validation Clinical reporting Quality Assurance Clinical – Internet Explorer Study Template Study Instantiation Consolidated Clinical Data Warehouse Templates Studies Legacy Clinical Data Repositories netTrials PDMS Etc.. Map to study Batch Data Load Transformation Normalization CDEification Extract Format Current Clinical Data Repositories MIS Labs (CDW) Navy Labs (HL7) netTrials PDMS Etc..

14. ® Remote Data Capture (RDC) Matrix

15. ® RDC – Enrollment CRF

16. ® Enrollment CRF CDEs

17. ® Discoverer Enrollment Extract View

18. ® Discoverer Theradex EN File View