Implementation of a Validated Statistical Computing Environment

1
Implementation of a Validated Statistical
Computing Environment

• Presented by Jeff 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
SAS, Files
Documentum/Publishing
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
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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
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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

12
Repository

• Secure Oracle Database
• Easily retrievable
• Hierarchical Structure
• Indication -gt Study -gt 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

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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

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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 -gt main program -gt
  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

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

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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_at_hgsi.com
• 240-314-4414