Looking to the future: Medidata Rave

LOOKING TO THE FUTURE:
MEDIDATA RAVE
Laura Smith
P1115 Training
November 2015
AGENDA
• Background
• System Features
• Data Collection Screens
• Transition
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WHAT IS A CTDMS?
• CTDMS = Clinical Trials Data Management System
• Web-based solutions for managing clinical trials data
• One location for managing data
o
Enter and view data
o
View data collection screens
o
Perform quality assurance
o
Respond to data discrepancies/queries
o
Generate various site reports
• There are numerous CTDMS on the market
o
Medidata Rave was selected for the ACTG and IMPAACT networks
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WHY ARE THE ACTG AND IMPAACT
NETWORKS TRANSITIONING TO A CTDMS?
• Computing technology is rapidly changing
o
o
A large company with many diverse clients can
support such a system
Ability to add many new and enhanced features
• The Statistical Data Management Center
(SDMC) does not have the resources to develop
existing systems to that extent over the long term
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WHY TRANSITION? (CONT’D)
• Implementation of a CTDMS will allow us to
meet the needs of the network in the future as
data evolves
• CTDMS are compatible with CDISC standards
o
Required as part of the last grant recompetition for
both the ACTG and IMPAACT networks
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WHAT IS CDISC?
CDISC = Clinical Data Interchange Standards Consortium
• Outside organization:
o
Streamline data collection
o
Facilitate data sharing and data exchange
• DAIDS-mandated
• FDA will require CDISC for future submissions
WHY WAS MEDIDATA RAVE
SELECTED?
• Vendor experienced with large NIH•
•
•
•
sponsored clinical trials
FSTRF has experience with Rave in nonACTG & IMPAACT projects
Large company, founded in 1999 with
numerous, diverse clients
Met CDISC reporting requirements
Best met other requirements
o
Supports coding and monitoring features
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WHAT DOES MEDIDATA RAVE
LOOK LIKE?
• Homepage:
o
o
Enrollments to a study
Task Summary
SUBJECT HOME PAGE
• Subject homepage displays expected visit schedule
o
Folder in left panel contains required forms for that visit
• Links in task summary will take you to the issue
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TRIGGERING A QUERY
• Queries appear in data collection screen
upon saving
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MODIFIED DATA
• Yellow delta shows that the data were changed
• Query disappears but can still be tracked in the audit trail
EXPLANATION OF CORRECT DATA
• Add reason data are correct directly in data collection screen
STICKY NOTES AND COMMENTS
• Sticky notes and comments alert you to a new data collection
screen or additional question without triggering a query
• Dynamic – data collection screen or question added based on
participant’s data
SUBJECT ENROLLMENT SYSTEM
• Sites will continue to use the
subject enrollment system for all
enrollments
o
This process is not changing
• Enrollments will appear in
Medidata Rave after a short
period
o
At that time, visits and data
collection screens will be available
to sites for data entry
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LABORATORY DATA
MANAGEMENT SYSTEM (LDMS)
• Use of the LDMS will continue
o
However, they are moving to a web-based LDMS
o
Visit the LDMS Demo Room for more information
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DATA COLLECTION SCREENS
AND PRINTING
• Data collection screens will be available electronically
o
Created directly in Medidata Rave
o
Differ from the case reports forms sites have used in past
• Most data collection screens will be available in
Medidata Rave
o
Forms will no longer be printed and shipped to sites
o
However, some participants questionnaires will only be available
on DMC Portal for sites to print
• Sites may want to consider going to a direct data entry
model
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PRINTING: PDF EXAMPLE OUTPUT
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GRADUAL TRANSITION
• SDMC will work with network leadership to
determine which studies will use Medidata Rave
• Both existing systems and new CTDMS will be in
place for 2-3 years
o
o
o
Most studies in progress will continue to use existing systems
Transition of long-term studies will be decided on a case
by case basis
New studies will be developed directly in Rave
• Communication with sites will be important in this
process
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INITIAL STUDIES PLANNED FOR
MEDIDATA RAVE
New Studies
A5350
A5352s
Existing Studies to be Migrated
A5322
P1115
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SITE TRAINING
• The SDMC is in the initial stages
of Rave configuration
• Site training is being planned
and will be announced as it
develops
• eLearning modules are
available within Medidata Rave
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SUMMARY:
CHANGE TO MEDIDATA RAVE CTDMS
• There will be changes in data collection
• System will allow for new features:
o
Web-based system with real-time changes
o
Streamlined data entry
o
Visit-specific folders contain required data collection screens
o
New reports and possibilities for quality assurance
• Transition will be gradual
• Case report forms will no longer be printed and shipped to the
DMC
o
They will be replaced by data collection screens available for
viewing and printing within Medidata Rave
• Will require changes for networks, DAIDS, study teams, SDMC,
sites, and monitors in how data is managed
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MORE INFORMATION?
• Contact [email protected]
with questions or comments.
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QUESTIONS AND COMMENTS?
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