Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office.
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Transcript of Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office.
STREAMLINING YOUR RESEARCH WORKFLOW
Bree Burks, RN, MSN, CCRP
Cerebrovascular Clinical Research Office
Outline Background Why streamline How to streamline Choosing your tools REDCap in clinical trials REDCap for leading multicenter clinical
trials Other REDCap uses
Background
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
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
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
BackgroundInitial Goals: Consolidate Accomplish More
Why streamline?
Efficiency
Cross-coverage
Transparency
Cross-coverage
Data-driven decision making
SILOS
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
How to streamline?
Create uniform processes
FIRST: Incorporate input from your teamSECOND: Commit to a shared process
Electronic workflow Your best insurance policy
How to streamline?
Choose your toolDefine your purpose
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
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
REDCap in clinical trials
Organize contact information Store workflow checklists Document adverse events and assessments Store PI signatures verifying oversight of data
THERAPY Documentation
REDCap in clinical trials
Organize contact information Store workflow checklists Document adverse events and assessments Store PI signatures verifying oversight of data
THERAPY Documentation
REDCap- leading multicenter clinical trials
Upfront Regulatory Documents
Ongoing Regulatory Documents
Remote Monitoring
Data Resolution
Other REDCap uses
Orientation and Training
Screening
Quantify your Workflow
SOP’s (ie: collections of documents with multiple versions)
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)
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
THANK YOU!
Questions-please!!