Implementation of a Validated Statistical Computing Environment

1. Implementation of a Validated Statistical Computing Environment Presented byJeff Schumack, Associate Director – Drug Development Information September 16, 2005

2. Statistical Computing Environment (SCE) • Data Repository of source code, input data & output • Version controlled programs and output • Reusable programming ability • Links to Clinical Data Management System (CDMS) & Documentum

3. Prototype • Determined requirements • Performed market search • Worked collaboratively to achieve our vision • Conducted extensive pilot

4. SCE: Where Does it Fit in? Clinical Data Management Capture and Organize Data Clintrial/CRO Clinical Biostatistics Regulatory Affairs Analyze Data, Generate and Deliver Reports Submission of Reports to the FDA Documentum/Publishing SAS, Files Statistical Computing Environment Analysis, Programming and Reporting under 21 CFR Part 11 compliance

5. Interfaces Clinical Data Management • Core SCE • Documentum

6. Clinical Data Management Connector

7. Extraction Process Query CDMS • SAS or XML • Execute data extraction • Extraction in context • Record data and output under correct study

8. Audit Trails • Who • What • When • Comment if any

9. Core SCE Functionality

10. Database Connectivity Oracle Role Based Security • Require username / password • Secure – only authorized personnel allowed to connect • Level of access based on user privilege

11. External Applications • SAS system version 8.12 (or higher) • R (Splus) version 1.9.1 or higher • UltraEdit version 10 or higher

12. Repository • Secure Oracle Database • Easily retrievable • Hierarchical Structure • Indication -> Study -> Programs (etc.)

13. Traceable Pathway SCE provides • Clear pathway from “field” to report • Mechanism for data extraction of analyses • Dependency map of input-to-programs-to-output • “Push” analyses into Documentum • Audit Trails

14. Dependency Map Graphically represent “program-to-input-to-output” – Including version numbers

15. Security Manager • Individual user accounts • Password Management: LDAP • Permissions: • Group • User • Project

16. File Management • Folder types / File types / File properties • Check out / Check in • File annotations • Source Code Editor • File Viewers • Execution and display results, logs, graphics • Audit Trails

17. Pack & Go • “Pull” files from SCE onto local disks • Indication • Study • Analysis • Useful for Archival • Collaboration with external contributors • Partners • CROs • Data Monitoring Committees

18. Study Setup - Templates • Nested Hierarchy templates • Indication • Study • Analyses • Replicate Studies using templates • Retire templates no longer in use

19. Job Management • Server based running of jobs • Define jobs / Submit jobs / Run jobs / Run & Record • Input / output dependencies • Table of Content user interface / comment blocks • Relative file pathways • Macro search • Common Code search • Batch execution / job sequencing • Record Outputs • Traceability – Dependency Mapping • Input data / program / macros -> main program -> Output (s)

20. Life Cycle Management • Draft / Quality Controlled / Final • Business rules • Draft from Final

21. Reporting • Audit Trail reports • Output formats – PDF, XML, RTF etc. • Combine Outputs • Interface with external reporting tools

22. Documentum Connector

23. Documentum Authentication • Username / password protected • Documentum user information verification • Documentum permissions verification

24. User Interface • Automatic population of Documentum based on lifecycle state of document in SCE • Manual population based on user triggers • User comments • Version controls

25. Audit Trails • Who • What • When • Version control information

26. Conclusion • New technology • Close to realizing HGS SCE vision • Acknowledgments: • HGS Biostats & IT teams • Waban Software • Alan Hopkins • Contact Information: • Jeff_Schumack@hgsi.com • 240-314-4414