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MULTI-SPONSOR DATA TRANSPARENCY: A GROUP APPROACH TO SHARING
BILL GIBSON – PHUSE – 2014 TT04
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PHUSE 2014 – TT04 TOPICS COVERED
• The Multi-Sponsor Approach and Introduction • Main Sponsor Processes • Researcher Activities
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THE MULTI-SPONSOR APPROACH INTRODUCTION
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SOLUTION OVERVIEW Pu
blic
acc
ess
site
• Researcher request process
• New data inquiries
Inde
pend
ent R
evie
w
Pane
l and
Pro
cess
• Panel • Notification
The
Res
earc
her
Acc
ess
Solu
tion • Secure storage
and access of data • A collaborative,
analytic environment
• Easily accessible from anywhere with all tools included
Multi-Sponsor Environment • Playing nicely with your peers
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SAS Clinical Trial Data TransparencyMulti-‐Sponsor Environment -‐ Extended
SAS Researcher Environment
Terminal Services Firewall
Remote Desktop
Researcher(s)
Company 1
Company ...
Company 2Company n
Manual Review
Import/Export Gatekeeper
Controlled, authenticated access
Shared Content Repository Logically separated by company
MULTI-SPONSOR ENVIRONMENT
• Shared environment • Logically segregated sponsor data • Researcher access to multiple
sponsors’ information • Research Project-based model • Supports requests for multiple
sponsors’ data • Distributed costs for hosting,
hardware, administration and support
• Supports low-entry cost for non-profits
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MAIN SPONSOR PROCESSES OVERVIEW
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PHUSE 2014 – TT04 MAIN SPONSOR PROCESSES
Once a research grant is approved by all involved sponsors • Data Preparation and De-identification • Information Upload • Usage Metrics Review • Managing Researcher Download Requests
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MAIN SPONSOR PROCESSES DATA PREPARATION AND DE-IDENTIFICATION
• Clinical Trial data and supporting documentation collected • CSRs and Data are processed for de-identification/redaction/anonymization
• Multiple de-identification methods defined • PhUSE workshop Sunday, Jean-Marc Ferran’s presentation Tuesday • Transcelerate and others have provided recommended rules
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UPLOAD ARCHIVE – STUDY CONTENTS AND METADATA
Contents of sample ini file: # Values for type are STUDY or RESEARCH AREA Type=STUDY # Value for name must – must be valid directory/file name
Name=ACME-12345 # Value for description to be used by Researcher Description=Study sample SponsorID=MSE_ACME
To update add: AppendFiles=Yes
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MAIN SPONSOR PROCESSES UPLOAD DATA
Option 1: • Normal SFTP transfer • Each sponsor has
their own account
Option 2: Upload via the Portal – Options -> File Processing Uploads
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MAIN SPONSOR PROCESSES UPLOAD DATA PORTAL
All company-specific upload logs are found here
Portal uploads and SFTP produce same results in repository
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MAIN SPONSOR PROCESSES USAGE METRICS REVIEW
Dashboard and Reports
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MAIN SPONSOR PROCESSES MANAGING RESEARCHER DOWNLOAD REQUESTS
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RESEARCHER PERSPECTIVE OVERVIEW
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PHUSE 2014 – TT04 RESEARCHER PROCESSES
Once a research grant is approved by all involved sponsors • Research Granted, Data Access Provided • Data Analysis Via SAS and R • Report Download Request
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RESEARCHER PROCESSES RESEARCHER VIEW OF PROVIDED DATA
Researcher granted read-only access to one or more sponsor uploaded studies
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MSE RESEARCHER VIEW – REMOTE DESKTOP
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RESEARCHER PROCESSES REPORT DOWNLOAD REQUEST
Researcher logs into Export Request utility Researcher fills out Export request
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