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Justine Shults, PhD & Andrew J. Cucchiara, PhD ITMAT Center for Human Phenomic Science (CHPS)

Explore the benefits and features of the REDCap system for electronic data capture in clinical and translational research. Learn about user support, security, documentation, and biostatistics roles, and how to access REDCap resources effectively.

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Justine Shults, PhD & Andrew J. Cucchiara, PhD ITMAT Center for Human Phenomic Science (CHPS)

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  1. Clinical and Translational Research 101Informatics and Biostatistics SupportBRB 14th Floor Faculty Lounge September 6, 2018, 10:30-10:50 AM Justine Shults, PhD & Andrew J. Cucchiara, PhD ITMAT Center for Human Phenomic Science (CHPS) shultsj@email.chop.edu & andy@upenn.edu Research Electronic Data Capture (REDCap) redcap@mail.med.upenn.edu ITMAT Study Design and Biostatistics Core (SDAB) sdab@mail.med.upenn.edu UPenn’s Office of Software Licensing https://secure.www.upenn.edu/business-services/softwarelicenses

  2. Institute for Translational Medicine And TherapeuticsBecome an ITMAT member:www.ITMAT.upenn.edu

  3. Center for Human Phenomic Science (CHPS)

  4. ITMAT Funding Opportunities Available atwww.itmat.upenn.edu/funding.shtml Sharing Partnership for Innovative Research in Translation (SPIRiT) Program

  5. CHPS Junior Investigator Pilot Grant (JIPG)

  6. Research Electronic Data Capture (REDCap)https://redcap.med.upenn.edu

  7. Requirements for Informatics Systems • Provide Adequate Capacity • Maintain Secure Storage • Allow Appropriate Access to Data • Generate Case Report Forms • Develop Good Data Structures • Allow Export to Other Applications • Provide Access to Technical Support • Easy to Apply for REDCap Account • Reasonably priced (or free?) access

  8. Advantages of the REDCap System (Research Electronic Data Capture): • Free of Cost Availability - REDCap software has no license fees • Web-based - build a project and input data from anywhere • Secure – authenticated web access to data with audit trails of access • Fast and flexible - project conception to production within a day • Multi-site access - concurrent access to project from many sites • Autonomy - researcher controls user access, completely • Exportability - for analysis using SAS, Stata, SPSS, S-Plus, R et al. • Customizable - investigators have control of project development • Collaborative –libraries of modifiable data dictionaries • Local and Developer Support • REDCap Technical Support Team and Monthly User Group Meetings • List of Frequently Asked Questions • Local Support access to REDCap developers via weekly meetings • Advanced features include … • Mid-study database modification • Branching logic {if ever smoked then for when and amount per day} • Calculated fields {e.g. body mass index from height & weight} • Automatic validation (range check/data integrity) in real time • Double data entry for verification • Mobile interface for smart phones and tablet computers

  9. REDCap Documentation • Training Resources for REDCap: • Frequently Asked Questions [Help/FAQ] • REDCap Video [Training Resources] • Coursera Data Mngmt for Clinical Research • Joint CHOP/UPenn REDCap Users’ Group: • Second Tuesday of even numbered months or • Second Wednesday of odd numbered months • Meetings at Roberts Ctr or Colket TRB • Meeting alerts e-mailed a week before

  10. ITMAT’s CHPS Informatics Support • Assistance with Research Electronic Data Capture to • Design new REDCap data dictionary structures • Access existing REDCap data structure libraries • Validate and Verify REDCap data entries • Assign REDCap access privileges to collaborators • Import data into REDCap created by other systems • Export REDCap data to various software packages • Provide guidance in the use of Statistical Software • Facilitate use of graphical display software • Assistance with Access to the Penn Data Store • By CHPS Facilitator Services: • Michael R Rickels, MD, MS, Director • rickels@mail.med.upenn.edu • Carl Shaw, Med, MBA, CIP • shawcarl@upenn.edu

  11. REDCap Security Answers 11 • Was designed to be HIPAA compliant • Is Title 21 CFR, Part 11 capable, but … • Is NOT Title 21 CFR, Part 11 compliant • Consortium Title 21 CFR, Part 11 WIKI • Title 21 CFR, Part 11 Working Group

  12. REDCap Common Misconceptions: • Have PennKey  HaveREDCap? • REDCap server to all at Vanderbilt? • REDCap servers are interconnected? • One account for team is good idea? • Support 24/7/365? (No, it’s 9-5 M-F) • Support will create projects for you? • Faster response to personal e-mail? • Access to one projectaccess to all? • Multicenters have access to all data?

  13. Roles for Biostatistics in Study Design • Estimate Adequate Sample Size • Implement Appropriate Control Group • Develop an Optimal Analysis Plan • Produce Complementary Graphs • Help Communicate Results, Clearly • Reduce Time to Approval/Publication • Generate a Realistic Budget • Review Drafts of Proposal/Manuscript ... so, how does one obtain biostatistical support?

  14. Study Design and Biostatistics (SDAB)sdab@mail.med.upenn.edu

  15. CHPS Biostatistical Support • Obtain Guidance or Assistance from • Abbas Jawad (CHOP) • Andy Cucchiara (HUP & PPMC) • with designing your experiment • in estimating Sample Size or Power • to develop Statistical Analysis Plan • for production of Statistical Results • with Interpretation of Results • in Generating Presentation Graphics • for Reviewing Drafts of Manuscript

  16. UPenn Supported Software

  17. UPenn Site Licensing

  18. STATA Licenses and YouTube

  19. Free LastPass Premium License

  20. Do spreadsheets help you Excel? • Yes for Financial Accountants • No for Analysis (IBM “White Paper”) • No for Presentation Graphics • No for Data Management • Yes to develop Time & Events Chart • Powerpoint for presenting Schema • Which Statistical Package to use? • SAS or JMP - R (Microsoft) • IBM’s SPSS - Minitab • STATA - MatLab

  21. Take Away Messages: • Slides and Video will be Available • Be Sure to Sign Attendance Sheet • Do Apply for ITMAT Membership • Request a REDCap Account, ASAP • Ask for a Tour of CHPS Sites • at Dulles, Perelman, Presby or CHOP • Tell us about your research idea • Describe your database issues • Statistical questions are welcomed • Request a LastPass Premium license

  22. Tools for Planning Research Longitudinal Progression of Trial Time and Events Chart Assessments / Interventions

  23. Example of a Time & Events Chart:Two Period Crossover Design, Period 1

  24. Why develop Time & Events Chart? Time and Events Charts can help you… Prepare for In-Service Presentation to Facilitators Develop Case Report and Informed Consent Forms Screen for Inclusion/Exclusion Criteria Guidance for (CHPS?) Support Staff and Facilitators Facilitator Checklist for Processing Study Subjects Design your REDCap Project Database Dictionary Demonstrate Study Feasibility to Reviewers/Funders Provide Guidance for Statistical Analyst and Analysis Select Literature Review and Background Material Generate and Complement Study Design Narrative

  25. An Example of Study Schema: Dick Landis is the PI of an NIDDK-funded (National Institute of Diabetes and Digestive and Kidney Diseases), multi-institutional Data Coordinating Center - the Chronic Prostatitis Collaborative Research Network (CPCRN)

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