Implementation of
a Validated
Statistical
Computing
Environment
Presented by
Jeff Schumack, Associate
Director – Drug Development
Information
September 16, 2005
Statistical Computing
Environment (SCE)
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Data Repository of source code, input data & output
Version controlled programs and output
Reusable programming ability
Links to Clinical Data Management System (CDMS) &
Documentum
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Prototype
• Determined requirements
• Performed market search
• Worked collaboratively to achieve our vision
• Conducted extensive pilot
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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
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Interfaces
Clinical Data
Management
Core SCE
Documentum
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Clinical Data Management
Connector
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Extraction Process
Query CDMS
• SAS or XML
• Execute data extraction
– Extraction in context
– Record data and output under correct study
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Audit Trails
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Who
What
When
Comment if any
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Core SCE Functionality
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Database Connectivity
Oracle Role Based Security
• Require username / password
• Secure – only authorized personnel allowed to connect
• Level of access based on user privilege
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External Applications
• SAS system version 8.12 (or higher)
• R (Splus) version 1.9.1 or higher
• UltraEdit version 10 or higher
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Repository
• Secure Oracle Database
• Easily retrievable
• Hierarchical Structure
– Indication -> Study -> Programs (etc.)
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Traceable Pathway
SCE provides
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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
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Dependency Map
Graphically represent “program-to-input-to-output”
– Including version numbers
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Security Manager
• Individual user accounts
• Password Management: LDAP
• Permissions:
– Group
– User
– Project
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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
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Pack & Go
• “Pull” files from SCE onto local disks
– Indication
– Study
– Analysis
• Useful for Archival
• Collaboration with external contributors
– Partners
– CROs
– Data Monitoring Committees
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Study Setup - Templates
• Nested Hierarchy templates
– Indication
– Study
– Analyses
• Replicate Studies using templates
• Retire templates no longer in use
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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)
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Life Cycle Management
• Draft / Quality Controlled / Final
• Business rules
• Draft from Final
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Reporting
• Audit Trail reports
• Output formats – PDF, XML, RTF etc.
• Combine Outputs
• Interface with external reporting tools
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Documentum
Connector
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Documentum Authentication
• Username / password protected
• Documentum user information verification
• Documentum permissions verification
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User Interface
• Automatic population of Documentum based on
lifecycle state of document in SCE
• Manual population based on user triggers
• User comments
• Version controls
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Audit Trails
• Who
• What
• When
• Version control information
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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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