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

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

19. UPenn Supported Software

20. UPenn Site Licensing

21. STATA Licenses and YouTube

22. Free LastPass Premium License

23. 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

24. 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

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

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

27. 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

28. 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)