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Implementation of a Validated Statistical Computing Environment in Drug Development

This presentation by Jeff Schumack, Associate Director at Drug Development Information, outlines the implementation of a Validated Statistical Computing Environment (SCE). The SCE serves as a data repository for source code, input, and output, featuring version-controlled programs and reusable programming capabilities. Key elements include robust connections to Clinical Data Management Systems (CDMS) and Documentum, strict compliance with 21 CFR Part 11, and comprehensive audit trails for data integrity. The session covers functional mechanisms, user security, job management, and collaborative frameworks for enhancing statistical analysis in clinical trials.

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Implementation of a Validated Statistical Computing Environment in Drug Development

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  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

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