Presentation is loading. Please wait.

Presentation is loading. Please wait.

Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office.

Similar presentations


Presentation on theme: "Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office."— Presentation transcript:

1 Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office

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 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 Dr. J Mocco Neurosurgery Dr. Michael Froehler Neurology Dr. Howard Kirshner Neurology Our Team… a multidisciplinary approach Cerebrovascular Clinical Research Office (CCRO) Jessica Collins Program Manager-StrokeNet Andrea Reed, MS Data Collector

5  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

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

7 Background

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

9 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 FIRST: Incorporate input from your team SECOND: Commit to a shared process Electronic workflowYour best insurance policy

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

12  Our Strengths FULLY ELECTRONIC TRIALS  Our Tools-REDCap  Created at Vanderbilt  Strong Collaboration  Flexible Incorporated Query Resolution Model Incorporated Project Management Functions Increasing… ComplianceAccountabilityWorkflow EfficiencyStudy Recreation Choosing your tools

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

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

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

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

18 Other REDCap Uses 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!!


Download ppt "Bree Burks, RN, MSN, CCRP Cerebrovascular Clinical Research Office."

Similar presentations


Ads by Google