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!!