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REDCap Databases and Other Tools to Advance Effective Research Infrastructure

REDCap Databases and Other Tools to Advance Effective Research Infrastructure Stuart T. Weinberg, MD FAAP Department of Biomedical Informatics Department of Pediatrics Vanderbilt University School of Medicine CC-CHOC Spring Meeting – April 30, 2010. Research Electronic Data Capture (REDCap)

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REDCap Databases and Other Tools to Advance Effective Research Infrastructure

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  1. REDCap Databases and Other Tools to Advance Effective Research Infrastructure Stuart T. Weinberg, MD FAAP Department of Biomedical Informatics Department of Pediatrics Vanderbilt University School of Medicine CC-CHOC Spring Meeting – April 30, 2010

  2. Research Electronic Data Capture(REDCap) Paul Harris, PhD Director, CTSA Biomedical Informatics OperationsDepartment of Biomedical Informatics, Vanderbilt University Information from BERD Annual Meeting – April 08, 2010

  3. REDCap Project Overview • 2004 Needs Assessment • Researchers needed help managing data for small/medium sized non-trial research • projects (pilot, R01, PPG) • Hypothesis • Researchers will do the right thing (secure, audit trails, etc) if provided an easy way to get needed tools • Problem • Many projects, few resources

  4. REDCap Project Overview • Solution: • Metadata-driven application (no per-project programming) • 2004 - First REDCap project operational at VU • 2006 - REDCap Consortium • Launched REDCap Consortium to share with other universities and foster collaboration for future development • 2008 – CTSA Informatics Pilot Project (IPP) Award • Increase capacity and streamline processes for collecting and managing data in diverse scientific areas of study

  5. Vanderbilt Support Model • Using CTSA funding, Vanderbilt offers REDCap and REDCap Survey tool at no charge to investigators. • Protects the Institution (centralized data capture, security) • Protects the researcher (data quality and continuity) • Protects the research participant (data security) • Cost effective - Informatics investment is minimal • Researchers create their own data dictionariesREDCap 101 Training (weekly); + Video (on demand) • REDCap 201 Training (bi-weekly) – Informatics + Biostatistics • We also run a fee-for-service core that is available to research teams when REDCap will simply not fit (Multi-Tier Model - Tier 1 is REDCap and used by 99% of projects) • Grant deadlines are the best time to make new friends … • (let’s create a REDCap database shell so you’ll have a screenshot to go along with this boilerplate language)

  6. REDCap Tour – Main Page Dynamic Project Status Users See All Projects Where They Have Edit/View Rights

  7. REDCap Application (Classic Model) CRFs – Customized For Each Study REDCap Core Modules– Available For All Studies Project-Level Metadata Defined by Research Team

  8. Case Report Forms PDFs Visual Status Data Validation NumerousField Types + Text (Free) (Number) (Phone) (Zip) (Date) +TextArea +Select +Radio +File HumanReadableLabels BranchingLogic Auto-Variable Coding

  9. Data Export + De-ID Tools EmbeddedDe-IdentificationTools Exports RawData + Stats Script Files (Labels, Coding

  10. Audit Trails / Data Logging Full Audit Logs – Data Changes and Page Views

  11. Multi-Center Study Setup Data stored centrally, but access is sequestered by site

  12. Data Visualization / Cleaning Automatically Graphs Categorical & Continuous Variables Primary Use Case: Data Cleaning -- Requires R-Apache Server Connection

  13. Custom Reports End-User Creation/Use of Custom Reports

  14. Web-Based Project Creation Point/ClickDrag (Ajax) For Real-time CRF Creation LongitudinalCRF Mapping Optional Participant SchedulingSetup Screens

  15. File-Based Project Creation

  16. 21CFR Part 11 --- Ready Scheduled for Release April, 2010

  17. REDCap Setup Tools (Instantiate New Project ~ 15 sec)

  18. Top-Down and In-Line Video Training Resources

  19. REDCap Survey Currently @ 17 Institutions 146,000 Surveys Collected

  20. Next - External Systems Interoperability API: Currently Beta-Testing - Consortium DTS: Alpha-Testing - VU, OHSU External Systems

  21. Next – Merging REDCap + REDCap-Survey Works Now In RC-Survey

  22. Next – REDCap Unplugged (No Internet) Beta-Testing – Consortium Works Now In RC-Survey

  23. Next – Improved Language Rendering Works Now In RC-Survey

  24. REDCap Consortium Model 6,270 End-Users 1,850 Projects 101 Institutional Partners (Full)

  25. REDCap Consortium Model

  26. REDCap Consortium ModelSoftware and Support Available at No Cost • www.project-redcap.org REDCap Evolution Depends On Concept Sharing and Input From Our Consortium (e.g. Small Project Guidance Groups) - We Could Use More Input From Biostatistics Experts

  27. Additional Information www.project-redcap.org paul.harris@vanderbilt.edu

  28. Additional Informatics Tools • Recruiting Patients -- Communication -- Population Identification -- Management in the Clinical Workflow • Patient Followup

  29. From: "Gordon Bernard" <vumc-recruitment-admin@vanderbilt.edu> Subject: Welcome to the Research Notifications distribution list Date: Wed, March 3, 2010 5:27 pm To: vumc-recruitment@LIST.VANDERBILT.EDU Colleagues, Given Vanderbilt's status as a leading research university, one of the more frequent email messages you received prior to the creation of the MyVUMC newsletter were announcements about clinical trials. We have been pleased with the ability of MyVUMC to consolidate important announcements and share them in a convenient format. However, we have received valuable feedback indicating that some employees wish to continue to receive clinical trials solicitations directly, and not through MyVUMC. Based on this feedback, we have developed a new option so those of you who wish to receive clinical trials announcements in this format are able to do so. In order to allow employees who wish to be notified of individual clinical trials announcements we are creating a VUMC employee email distribution list that will allow for you to receive individual notifications about these trials as they are routed through the Vanderbilt Institute for Clinical and Translational Research (VICTR). To unsubscribe now, please reply to this email and place the phrase UNSUBSCRIBE VUMC-RECRUITMENT at the beginning of your email message.

  30. From: research.notifications@vanderbilt.edu Subject: Volunteers with Heart Disease and/or Diabetes Needed for Study Date: Wed, March 31, 2010 2:17 pm To: vumc-recruitment@LIST.VANDERBILT.EDU Researchers at Vanderbilt University are looking for participants >= 18 years old, especially those over 45, who have diabetes and/or cardiovascular disease and/or are on cholesterol medications called "statins" for a research study to better understand the role of lipids in heart disease in patients with kidney disease. If you do not have kidney-related problems and you meet any of the criteria above you may qualify. The study will include a one-time blood draw. We will also collect information about your general health condition. Participants will be compensated for their time upon completion of the study. For more information, or to see if you qualify, please send an email to ikizler.lab@vanderbilt.edu.

  31. From: research.notifications@vanderbilt.edu Subject: Women Needed to Complete Anonymous, Self-Administered Questionnaire Date: Thu, April 22, 2010 4:26 pm To: vumc-recruitment@LIST.VANDERBILT.EDU The Department of Urologic Surgery at Vanderbilt University Medical Center in Nashville, Tennessee is investigating the prevalence of lower urinary tract symptoms in young women. This is being done by a voluntary, anonymous, self-administered questionnaire. We are seeking responses from all women, who may or may not have urinary complaints, who are between the ages of 18 and 40, and who are not pregnant. We estimate that it takes 5-10 minutes to complete. Your participation is strictly voluntary. There is no way to identify you personally or to contact you by the information you provide. We hope that you will choose to participate in what we feel is an important health concern in a heretofore underrepresented population. To access the questionnaire, please follow the link: http://tinyurl.com/yhga4ec Should you have questions regarding this research, we can be contacted via email at the following address: xxx or by phone at xxx. Thank you in advance for your consideration of this important survey.

  32. From: Tonya Sent: Wednesday, April 14, 2010 10:33 AM To: Sherry Subject: Research utilization of whiteboard Sherry - We would like to utilize whiteboard to alert providers of potential studies the patients would be candidates for. We had been making comments in the Appt Notes section; however, discovered that our notes were either deleted or overwritten by other comments. Is there a way we could have a column where we could place research information for the providers in clinic? Tonya Research Nurse Specialist III Vanderbilt Medical Center G I Clinical Research 1211 21st Ave South, room 103C Nashville, TN 37212-1610

  33. Summary • CTSA Funding has greatly assisted with efforts to match volunteers/researchers and manage the research data (ResearchMatch and REDCap). • Electronic workflow tools can be employed to automatically assess for potential recruits and track existing study patients in real-time.

  34. Thanks! • Contact Info: Stuart T. Weinberg, MD FAAP stuart.weinberg@vanderbilt.edu Office: 615-936-4239

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