1. REDCap User Group Meeting Special Meeting Meet the Experts Monday, September 15, 2014 10:00 am – 12:00 noon PSU Hershey – T2500 University Park – Henderson 115

2. Panel l PSU - Hershey n Allen Kunselman, PHS, Biostatistics n Rosanne Pogash, PHS Data Management n Terri Shkuda, Research Informatics n Christie Stetter, PHS, Biostatistics l PSU - University Park n Margaret Brech, Survey Research Center n Mengzhao Gao, Statistics n Larissa Witmer, Survey Research Center

3. Research Informatics Research Informatics supports the following CTSI resources with application maintenance and additional support as follows: l REDCap (Research Electronic Data Capture) - training, access, consultation, REDCap User Group Meetings, office hours l i2b2 (Informatics for Integrating Biology and the Bedside) – training, access, consultation, office hours l Profiles (Research networking software) l eagle-i (Biomedical research resource tool)

4. i2b2 – Informatics for Integrating Biology and the Bedside l Cohort discovery tool which can be used prior to IRB approval l De-identified database containing discrete data from HMC EMR, billing systems and other systems, with data from January 2011 to present l Feasibility tool to determine the existence of a set of patients meeting a specific criteria l Data contains: basic demographics, diagnosis, procedures, medications, lab tests, cancer registry, tissue availability

5. Research Informatics Contact l REDCap – redcap@hmc.psu.eduredcap@hmc.psu.edu l i2b2 – i2b2@hmc.psu.edui2b2@hmc.psu.edu l Profiles – profiles@hmc.psu.eduprofiles@hmc.psu.edu l eagle-i – researchcomputing@hmc.psu.eduresearchcomputing@hmc.psu.edu l CTSI website containing information about the above applications: https://ctsi.psu.edu/https://ctsi.psu.edu/

6. PHS Data Management Services l Develop data management plans l Design data collection forms l Design administrative forms to facilitate data collection and protocol adherence l Provide design assistance to investigators/coordinators creating REDCap projects l Create REDCap projects – forms, surveys, and data quality rules l Create an implement testing plans for REDCap designs and data quality rules l Perform data entry l Perform data monitoring activities

7. PHS Data Management Services l Up to 10 hours of services may be free using funds supported by the CTSI l Contact: n Rosanne Pogash Manager, PHS Data Management Unit n rpogash@psu.edu rpogash@psu.edu n 717-531-7689

8. CTSI BERD Support at CoM l BERD: Biostatistics, Epidemiology, Research Design l http://ctsi.psu.edu/ctsi- programs/biostatisticsepidemiologyresear ch-design/ http://ctsi.psu.edu/ctsi- programs/biostatisticsepidemiologyresear ch-design/

9. BERD Support at CoM l Clarification of study objective n With respect to clinical trials: u Superiority u Non-inferiority u Equivalence l Experimental design n Ex.: completely randomized, randomized complete block, Latin square, factorial, crossover, Bayesian, adaptive l Explicit definition of primary and secondary outcomes

10. BERD Support at CoM l Sample size and power l Identify potential sources of random error and bias l Randomization l Blinding methods l Interim analysis and stopping rules l Methods for handling missing data

11. BERD Support at CoM l Consideration for potential confounders and effect modifiers l Statistical data analysis l Interpretation l Reporting and graphics l Reproducible analysis l Data collection, management, monitoring, and archiving

12. BERD Support at CoM l Limited free BERD support l Request BERD support well in advance of any deadline l To request BERD support, complete the online consultation request form at: http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm

13. Survey Research Center (UP) l What is the SRC? n Part of the Social Science Research Institute n Experienced team of project managers to oversee data collection and project logistics l Provide survey and project management services l Promote and contribute to the science of survey research methodology l Educate the Penn State community about the best practices and emerging developments in survey research

14. Survey Research Center (UP) Data collection services l Multi-modal project management, including any of the following l Mail and self-administered surveys (scanned/data entry) l Phone surveys l Daily Diary Studies l Face-to-face interviews l In-school surveys l Web-based surveys l EMA Data Collection (DREAM) l Focus groups l Collection of biological samples

15. Survey Research Center (UP) l Project Management services n Help with study design decisions and instrument development n Develop project timelines, planning logistics n Coordinate multiple modes of data collection n Mailings (prenotifications, reminders, etc.) n Data collection staff hiring and training n Incentives n Scheduling and working with site contacts n Communication with respondents

16. Survey Research Center (UP) DREAM - Dynamic Real-time Ecological Ambulatory Methodologies l Smartphone surveys n Interval contingent, signal contingent, event contingent l Repeated collection of real-time data l Assess ongoing behavior, experiences, and environmental aspects of humans in their natural settings l Aims to understand processes as they naturally unfold in time and context l Phones and partnership with Verizon Wireless

17. Survey Research Center (UP) DREAM - Dynamic Real-time Ecological Ambulatory Methodologies l Ecological Momentary Assessment (EMA) l Experience Sampling l Daily diaries l Ambulatory physiological assessment l Physical and movement monitoring l Ambient environmental parameters l Opportunities with intervention studies

18. Survey Research Center (UP) l Contact: n Kurt Johnson, Ph.D. n Director, Penn State Survey Research Center n kdj11@psu.edu n 814-867-1290

19. CTSI BERD Support at UP BERD: Biostatistics, Epidemiology, Research Design at UP http://stat.psu.edu/consulting/ctsi- biostatistics-epidemiology-and-research- design

20. UP BERD Support l First four hours of consultation is provided free of charge. To request BERD support, complete the online consultation request form at: http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm http://webapp.hmc.psu.edu/walkin2/walkin_form.cfm l Graduate students and junior investigators will have priority for the free service. l Researchers may receive help with projects and grant preparations

21. UP BERD Support l Sample size and power analysis l Expertise in study design and statistical methodology l data collection, data management and data analysis l Genomic Data Analysis

22. Contact for UP CTSI BERD: l Dr. Mosuk Chow l mchow@psu.edu UP BERD Support