bree burks, rn, msn, ccrp cerebrovascular clinical research office
TRANSCRIPT
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STREAMLINING YOUR RESEARCH WORKFLOW
Bree Burks, RN, MSN, CCRP
Cerebrovascular Clinical Research Office
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Outline Background Why streamline How to streamline Choosing your tools REDCap in clinical trials REDCap for leading multicenter clinical
trials Other REDCap uses
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Background
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Jessica Marlin, CCRP Clinical Trials Specialist
Stephanie Smith, MA, CCRPProgram Manager-FEAT
Emily Gilchrist, MPHCerebrovascular Clinical Improvement and Research Coordinator
Bree Burks RN, MSN, CCRPManager-CCRO
Diane Brown, RN, BSN, CCRPResearch Nurse Specialist III
Dr. J MoccoNeurosurgery
Dr. Michael FroehlerNeurology
Dr. Howard KirshnerNeurology
Our Team… a multidisciplinary approach
Cerebrovascular Clinical Research Office (CCRO)
Jessica CollinsProgram Manager-StrokeNet
Andrea Reed, MS Data Collector
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Lead Coordinating Center Management of large, multicenter clinical trials
○ Conceptual Phase Publication
Multicenter Clinical Trial Data Management Create, Amend, and Oversee Electronic Data-capture (eDC) Systems
Automated Databases from EHR Intuitive data automation for all cerebrovascular patients at Vanderbilt Multidisciplinary use
Diverse Clinical Trials Trials for all patient populations treated clinically NIH StrokeNet- Regional Coordinating Center Diverse funding
CCRO
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Study Design
Protocol Development Statistics eDC
DevelopmentSite
Selection
Site SetupContract and
Budget Negotiations
IRB Submission
CMS Submission
Protocol Training
Subject Enrollment
eDC, Protocol, and
Clinical Support
Real-time Data
Monitoring
Continued Training
Study Completion
Site Close-out eDC Lock Data Analysis Publication
CCRO- “One-stop Shopping”
One, central study contact for participating sites-Project Lead
Study Design completed in house
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BackgroundInitial Goals: Consolidate Accomplish More
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Why streamline?
Efficiency
Cross-coverage
Transparency
Cross-coverage
Data-driven decision making
SILOS
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Why streamline?
clinical research = evidence-based practice
It’s ironic that we do not incorporate data into more of our own internal processes?
Data should drive:
What trials we run
What processes we need to reevaluate
How we should structure our workflow
When to hire additional staff
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How to streamline?
Create uniform processes
FIRST: Incorporate input from your teamSECOND: Commit to a shared process
Electronic workflow Your best insurance policy
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How to streamline?
Choose your toolDefine your purpose
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Our StrengthsFULLY ELECTRONIC TRIALS
Our Tools-REDCap Created at Vanderbilt Strong Collaboration Flexible
• Incorporated Query Resolution Model• Incorporated Project Management Functions
Increasing…
Compliance
Accountability
Workflow Efficiency
Study Recreation
Choosing your tools
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REDCap in clinical trials Traditional Uses
Inputting limited data sets for single center usage
Additional Uses Running large, multicenter clinical trials Regulatory documentation Notes to file Personnel Information Electronic Signatures
*Practically ALL documentation related to your clinical trial needs
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REDCap in clinical trials
Organize contact information Store workflow checklists Document adverse events and assessments Store PI signatures verifying oversight of data
THERAPY Documentation
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REDCap in clinical trials
Organize contact information Store workflow checklists Document adverse events and assessments Store PI signatures verifying oversight of data
THERAPY Documentation
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REDCap- leading multicenter clinical trials
Upfront Regulatory Documents
Ongoing Regulatory Documents
Remote Monitoring
Data Resolution
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Other REDCap uses
Orientation and Training
Screening
Quantify your Workflow
SOP’s (ie: collections of documents with multiple versions)
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Other REDCap Uses
Star Server
EDW
HEO
Dat
a P
arsi
ng
Information collected during clinical care
Vanderbilt’s Research Derivative Database
Current Clinical Trial Databases
Research
Retrospective Projects
Peer Review
Quality (QSRP)
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REDCap and Research…. What’s next?
Automated data into eDC systems
Comprehensive eDC/CTMS systems
Official “networks” with added efficiency
EMR’s structured like databases
Consolidation and shared resources
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THANK YOU!
Questions-please!!