Implementation of a Validated Statistical

Computing Environment

Presented by Jeff Schumack, Associate

Director – Drug Development Information

September 16, 2005

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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

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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?

Capture and Capture and Organize DataOrganize DataCapture and Capture and

Organize DataOrganize Data

Analyze Data, Generate Analyze Data, Generate and Deliver Reportsand Deliver Reports

Analyze Data, Generate Analyze Data, Generate and Deliver Reportsand Deliver Reports

Clintrial/CRO

SAS, Files Documentum/Publishing

Clinical Data Management

Clinical Biostatistics Regulatory Affairs

Statistical Computing Environment

Analysis, Programming and Reporting Analysis, Programming and Reporting under 21 CFR Part 11 complianceunder 21 CFR Part 11 compliance

Analysis, Programming and Reporting Analysis, Programming and Reporting under 21 CFR Part 11 complianceunder 21 CFR Part 11 compliance

Submission of Submission of Reports to the Reports to the

FDAFDA

Submission of Submission of Reports to the Reports to the

FDAFDA

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Interfaces

Clinical Data Clinical Data ManagementManagement

Core SCECore SCE

DocumentumDocumentum

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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

• 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• 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 MapGraphically 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