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Where we began…

Duke Office of Clinical Research (DOCR) “ We don ’ t do the research – you do. We just make it easier. ” Susan Budinger Associate Director of Research Operations. Where we began…. Collaboration started in 2010

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Where we began…

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  1. Duke Office of Clinical Research (DOCR) “We don’t do the research – you do. We just make it easier.”Susan BudingerAssociate Director of Research Operations

  2. Where we began… • Collaboration started in 2010 • Resources to design and implement projects that enhance resident/fellow education and move projects toward scholarly publication • Streamline resource navigation & supports best practices • Consult with DOCR while developing funding proposals • Collaboration has allowed both GME and PIs to learn what resources are really appropriate and see the value in all of the pieces that are required for project success Where we’re headed… • Resident and fellow education through dedicated workshops and blitzes

  3. DOCR Core Values

  4. The Not So Easy Part: Where to Start? Contracts Funding Data Security Project Management Data Management Staffing IRB Grant Writing Information Technology Publishing Billing Compliance Federal Regulations Students

  5. Multiple Priorities • Balancing caring for patients, managing cases, mentoring • Answering additional QI or research questions competes with work-related duties • The opportunity to collect more data may be more enticing than quality work or resources for documentation and testing • Finding time for required training

  6. Get Help Early - DOCR! Identifying Resource Needs • All residents and fellows must be involved in a QI project (ACGME requirement) • Research planning & support • Data management and database development if needed • Tools, technology and collaboration • Safeguard the highest possible degree of integrity in your project • Ensure that all methods and practices accelerate the timeline from data collection to data analysis and reporting Good planning and operationalizing will help ensure success!

  7. DOCR Toolbox • REDCap eCRF design and REDCap Survey • MS Access tracking database design and maintenance • Data cleaning • Data entry • Data management/ trouble shooting • Data mining/DEDUCE • Chart abstraction • Project management • Regulatory (IRB) support • Consent form development • Research design • Subject recruitment • Subject consenting and interviewing • Subject tracking and follow-up • Statistical support

  8. What is ? • Two web-based components: • REDCap (Research Electronic Data Capture) • REDCap Survey (free for anyone with Duke email address) • Features: • Embedded audit trail and database documentation (versus Excel spreadsheet) • Auto-validation, branching logic, calculated fields • Easily create new databases from previous versions • Export data to common data analysis packages • Univariate graphical views and descriptive statistics • Ability to import and export data

  9. Advantages of Partnering With DOCR • Teamwork approach to problem-solving • Readily available, research-trained staff • Navigation experts to increase efficiency for implementation • Understanding the regulations and how they apply • Whom do you talk to? What do you need to do? • Improved data quality and data security = improved research quality

  10. GME Resident Training Workshops • Four workshops offered four times/year starting in October: Human Subjects Research and Data Collection/Security Using Library Resources and Research Ethics IRB, Informed Consent and Regulations Presentation and Dissemination of Data • Complete all four and receive a Certificate of Research Education & free DOCR support (+ great CV material!) • Advanced training: Half-day weekend blitz training for fellows in February and April • Some programs may require this as part of curriculum

  11. GME Resident Training Workshops

  12. DOCR – We’re a big team, but here are the key players for GME support • Denise Snyder, Associate Dean • Sunita Patil, Lead coordinator for GME projects • Holly Tiemann, Coordinator of research education • Jeff Hawley, Senior analyst programmer • Rick Sloane, Statistician collaborator

  13. Thank you! Duke University School of Medicine CTSA Grant Number IUL1 RR024128-01 Snyder DC et al. Research Management Team (RMT): A Model for Research Support Services at Duke University. Clin Trans Sci 2012; 5:464-469. Sue Budinger Associate Director, DOCR Duke Office of Clinical Research (DOCR) 9th floor Hock Plaza Office: 919-613-8278 susan.budinger@duke.edu Alisa Nagler Assistant Dean for Graduate Medical Education 1086 Duke South, Yellow Zone alisa.nagler@duke.edu

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