1. Streamlining your Research workflow
Bree Burks, RN, MSN, CCRP
Cerebrovascular Clinical Research Office
Streamlining your Research workflow

2. Outline Background Why streamline How to streamline
Choosing your tools
REDCap in clinical trials
REDCap for leading multicenter clinical trials
Other REDCap uses

3. Background

4. Our Team… a multidisciplinary approach
Cerebrovascular Clinical Research Office (CCRO)
Our Team… a multidisciplinary approach
Dr. J Mocco
Neurosurgery
Jessica Marlin, CCRP
Clinical Trials Specialist
Stephanie Smith, MA, CCRP
Program Manager-FEAT
Emily Gilchrist, MPH
Cerebrovascular Clinical Improvement and Research Coordinator
Bree Burks RN, MSN, CCRP
Manager-CCRO
Diane Brown, RN, BSN, CCRP
Research Nurse Specialist III
Jessica Collins
Program Manager-StrokeNet
Dr. Michael Froehler
Neurology
Dr. Howard Kirshner
Neurology
Andrea Reed, MS
Data Collector

5. CCRO 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

6. CCRO- “One-stop Shopping”
Study Design
Protocol Development
Statistics
eDC Development
Site Selection
Study Design completed in house
Site Setup
Contract 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
One, central study contact for participating sites-Project Lead

7. Background
Initial Goals:
Consolidate
Accomplish More

8. Why streamline? SILOS Efficiency Cross-coverage Transparency
Data-driven decision making

9. clinical research = evidence-based practice
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

10. How to streamline? Create uniform processes Electronic workflow
FIRST: Incorporate input from your team
SECOND: Commit to a shared process
Electronic workflow
Your best insurance policy

11. How to streamline?
Choose your tool
Define your purpose

12. Choosing your tools Our Strengths Our Tools-REDCap Increasing…
FULLY ELECTRONIC TRIALS
Increasing…
Compliance
Accountability
Workflow Efficiency
Study Recreation
Our Tools-REDCap
Created at Vanderbilt
Strong Collaboration
Flexible
Incorporated Query Resolution Model
Incorporated Project Management Functions

13. 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

14. REDCap in clinical trials
THERAPY Documentation
Organize contact information
Store workflow checklists
Document adverse events and assessments
Store PI signatures verifying oversight of data

15. REDCap in clinical trials
THERAPY Documentation
Organize contact information
Store workflow checklists
Document adverse events and assessments
Store PI signatures verifying oversight of data

16. REDCap- leading multicenter clinical trials
FEAT
Upfront Regulatory Documents
Ongoing Regulatory Documents
Remote Monitoring
Data Resolution

17. Other REDCap uses Orientation and Training Screening
Quantify your Workflow
SOP’s (ie: collections of documents with multiple versions)

18. Other REDCap Uses Information collected during clinical care
Data Parsing
Information collected during clinical care
Vanderbilt’s Research Derivative Database
Current Clinical Trial Databases
Research
Retrospective Projects
Peer Review
Quality (QSRP)

19. 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

20. THANK YOU!
Questions-please!!