looking to the future: medidata rave
TRANSCRIPT
LOOKING TO THE FUTURE: MEDIDATA RAVELaura SmithP1115 TrainingNovember 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 datao View data collection screenso Perform quality assurance o Respond to data discrepancies/querieso Generate various site reports
• There are numerous CTDMS on the marketo 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 changingo A large company with many diverse clients can
support such a systemo 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 standardso Required as part of the last grant recompetition for
both the ACTG and IMPAACT networks
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WHAT IS CDISC?
• Outside organization:o Streamline data collectiono Facilitate data sharing and data exchange
• DAIDS-mandated• FDA will require CDISC for future submissions
CDISC = Clinical Data Interchange Standards Consortium
WHY WAS MEDIDATA RAVE SELECTED?
• Vendor experienced with large NIH-sponsored clinical trials
• FSTRF has experience with Rave in non-ACTG & 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 Enrollments to a studyo 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 enrollmentso This process is not changing
• Enrollments will appear in Medidata Rave after a short periodo At that time, visits and data
collection screens will be available to sites for data entry 14
LABORATORY DATA MANAGEMENT SYSTEM (LDMS)
• Use of the LDMS will continueo However, they are moving to a web-based LDMSo 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 Raveo Differ from the case reports forms sites have used in past
• Most data collection screens will be available in Medidata Raveo Forms will no longer be printed and shipped to siteso 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 16
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 yearso Most studies in progress will continue to use existing systems
o Transition of long-term studies will be decided on a case by case basis
o New studies will be developed directly in Rave
• Communication with sites will be important in this process 18
INITIAL STUDIES PLANNED FOR MEDIDATA RAVE
New StudiesA5350A5352s
Existing Studies to be MigratedA5322P1115
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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 changeso Streamlined data entryo Visit-specific folders contain required data collection screenso New reports and possibilities for quality assurance
• Transition will be gradual• Case report forms will no longer be printed and shipped to the
DMCo 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 21
QUESTIONS AND COMMENTS?
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