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

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

Background

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

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

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

Background Initial Goals: Consolidate Accomplish More

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

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

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

How to streamline? Choose your tool Define your purpose

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

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 THERAPY Documentation Organize contact information Store workflow checklists Document adverse events and assessments Store PI signatures verifying oversight of data

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

REDCap- leading multicenter clinical trials FEAT 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 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)

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!!