Welcome Master’s Program Orientation

1. WelcomeMaster’s Program Orientation Center for Clinical and Translational Science Educational Resources

2. Agenda • Introductions • CCaTS Program Overview • Master’s Requirements • Research Proposal • Scholar/Mentor Relationships • Competencies • Program Evaluations & Outcomes • Questions

3. Mayo Clinic Center for Clinical and Translational Science (CCaTS) Sundeep Khosla, MDCCaTSDirector and Principal Investigator Scott Kaese, MBA CCaTSDirector of Administration Jane Welter, MBA CCaTSAssociate Director of Administration Laura Meiners, MBACCaTSOperations Manager Drug Discovery and Development Andrew Badley, MD Co-PI and Director ResearchResources Sundeep Khosla, MD PI and Director Late Stage Translational Research Victor Montori, MD Co-PI and Director CommunityEngagement Victor Montori, MDCo-PI and Director Consultative, Regulatory and Informatics Services Rickey Carter, PhD Christopher Chute, MD Richard Sharp, PhD Education Resources David Warner, MDCo-PI and Director Consortia Development Robert Rizza, MD Co-PI and Director Sanford Burnham Medical Research Institute Office for Community Engaged Research Pre-doctoral Programs Translational Technology Cores Study Design and Biostatistics Translating Comparative Effectiveness Research into Practice Midwest Area Research Consortium for Health (MARCH) Post-doctoral Programs Research Ethics Program Specialized Phenotyping Facilities University of Minnesota CTSI Practice- Based Research Networks Research Team Education Biomedical Informatics Clinical Research Units University of Mississippi Medical Center Regulatory Support Research Subject Advocacy Services Dartmouth-Synergy CCTS Research Information Center Intramural Awards Program Internal Advisory Committee Communications External Advisory Committee

4. Mayo ClinicCenter for Clinical and Translational Science (CCaTS) • CCaTS Research Resources (CRU) • CCaTS Community Engagement • CCaTS Consultative, Regulatory and Informatics Services • CCaTS Education Resources – David O. Warner, MD, Director Glenn E. Smith, PhD, LP, Associate Director

5. Prasad Iyer, M.D. Director, Postdoctoral Programs Shawna L. Ehlers, Ph.D., L.P. Associate Director, Postdoctoral Programs Katrin Frimannsdottir, Ph.D. Director of Program Evaluation Karen Weavers – Operations Manager Tauna Juenger – Operations Coordinator Jesse Welch– Education Specialist Curriculum Linda Wenner –Education Specialist Master’s Ashley Noelke– Administrative Assistant Postdoctoral Administrative Staff

6. CCaTS Postdoctoral Program Goal: To train clinicians to participate in intramurally- and extramurally-funded patient-based research. The Social Contract of Medical Research (discovering and applying knowledge to improve health) is a privilege. AAMC-GREAT Group

7. CCaTS Master’s Degree Program Goal: To train independent investigators to perform outstanding extramurally-funded patient-based research. The Social Contract of Medical Research (discovering and applying knowledge to improve health) is a privilege. AAMC-GREAT Group

8. Master’s Program Expectations • Find time for coursework: • 1 hour lecture = 2-4 hours outside work • 1 credit = 48 hours/qtr or 4 hours/week • 3 credit/quarter ~ 12 hours/week • Aligned with research goals • Accept feedback from mentors/tutors/peers • Learn to identify the important questions • Take charge of your destiny • Submit by deadlines indicated

9. Master’s Program Requirements • 24 didactic credits – GPA 3.0 • 16 required, 8 electives • “Writing for Biomedical Publications” workshop • “Writing Winning Grants” workshop • Written Comprehensive Examination • Research resulting in thesis with 2-3 possible publications • Final Oral Examination

10. Required Coursework • CTSC 5020 Regulatory Issues (1 cr) • CTSC 5690 Critical Appraisal (1 cr) • CTSC 5720 Clinical Trials (1 cr) • Mayo Graduate School Course Information • CCaTS Annual Course Schedule • CTSC 5300, 5310 and 5390 Clinical Epidemiology (4cr total) • CTSC 5600, 5601 and 5610 Statistics in Clinical Research (6 cr total) • CTSC 5010 Clinical Research Protocol Development (2 cr) • CORE 6000 Responsible Conduct of Research (1 cr)

11. Potential Elective Courses Clinical Trials Behavioral Individualized Medicine Healthcare Delivery • CTSC 5640 Logistic Regression • CTSC 5650 Survival Analysis • CTSC 5720 Clinical Trials: Design & Conduct • MPET 6820 Regenerative Medicine • CTSC 5080 Eliminating Health Disparities • CTSC 5810 Qualitative Research Design • CTSC 5860 Behavioral Interventions in Clinic Research • CTSC 5870 Social & Behavioral Foundations of Health in HSR • BMB 8350 Intro to Bioinformatics • CTSC 5140 Epigenetics and Epigenomics • CTSC 5660 Design analysis & App of Bioinformatics • CTSC 5960 Medical Informatics • CTSC 5760 Medical Decision Making • CTSC 5761 Evidence Based Medicine for Clinical Researchers • CTSC 5910 Economic Evaluation in Health Care • CTSC 5940 Secondary Data Analysis

12. Workshops • Required Workshop: • Writing for Biomedical Publications • March ~ offered once per year only • Available at all three sites (MCR, MCA, MCF) • Registration Fee - $275 (fee waived) • Optional Workshop: • Write Winning Grants • November ~ offered once per year only • Available at all three sites (MCR, MCA, MCF) • Registration Fee - $275 (fee waived)

13. Research Proposal • Utilize CTSC 5010 Clinical Research Protocol Development • If you take course in the fall, submit proposal in January • If you take course in the spring, submit proposal in July • Research Proposal Format • Reviewed using the Research Proposal Review Criteria • Research Proposal Packet Includes: • Cover page • Cover letter signed by your mentor • Research proposal • Division research committee approval • IRB approval • Submission cycle to CCaTS review is twice each year • January or July only • Early submissions are accepted

14. Thesis Advisory Committee (TAC)(due with proposal, January or July 1) • Minimum of 4 members – • Thesis Advisory Committee (TAC) Form • Recommended Action on Thesis Protocol Form • TAC and scholar have defined roles and expectations • Chair - usually primary mentor – only member who can also be co-investigator (exception for statistician) • Members - need MGS Faculty Privileges (check Catalog) • Oversees progress and quality of research project • Meet every 6 months to review progress of scholar • Submit summary of Progress Report Meetings to CCaTS • Becomes Examining Committee at Thesis Defense

15. Master’s Degree Program Form (DPF)(due with proposal, January or July 1) • Include courses you propose to take to fulfill degree requirements (24 credits total; 17 required) • Can transfer in up to 6 credits (25%) and may require taking a test • Master’s Degree Program Form on Mayo Graduate School Web site

16. Comprehensive Written Exam • Taken after completion of (14 cr): • Protocol Development • Epi I & II • Advanced Applied Epi (III) • Stats I & II • Critical App of Stat Methods (III) • Clinical Trials Design • Full day exam • 3rd Thursday of January, April or August

17. Final Oral Examination –Thesis Defense • After completion of all course work, approval of DPF, research proposal and TAC and Comprehensive Written Exam • Follow CCaTS andMGS Thesis Guidelines • Six weeks prior to your anticipated defense date – • Submit thesis draft for CCaTS review (allow 1 week) • Find a date/time all TAC members will be present • Allow 3 weeks for TAC to review final draft and prepare examination questions • After successful defense, submit Verification of Thesis Corrections and Final thesis to Mayo Graduate School • Complete Evaluations

18. Program Timeline • Research Proposal Packet – July or January 1 • Writing Workshop – March 2015 • Publishing Workshop – November 2014 • Progress Report – 6 months after research proposal approval and every 6 months thereafter • Coursework complete (3.0 GPA) • Written Comprehensive Exam – 3rd Thursday of January, April and August only • Thesis submission to CCaTS • Final Oral Examination

19. Scholar and Mentor Relationships Expectations These are meant as a guide to help facilitate optimal scholar/mentor relationships. Contact CCaTS if issues arise. • Initial Agreement – at time of application • Progress Report – submit 6 months after research proposal is approved and every 6 months thereafter • Mentoring Effectiveness Assessment (Scholar & Mentor) – will be requested annually, spring quarter.

20. Competencies • Critically evaluate clinical/translational research in the medical literature • Articulate the ethical & legal responsibilities of an investigator • Develop feasible and testable hypotheses • Design and conduct a clinical/translational research project • Write competitive grant proposals • Effectively communicate research results through publications and presentation

21. Competencies (cont.) • Articulate and apply appropriate study designs • Use appropriate bio-statistical methods • Understand the peer-review process • Ability to navigate the peer-review process for grants and papers

22. Program Evaluations & Outcomes Program Evaluation Activities • Clinical Translational Research Appraisal (CTRAI) Pre/Post self-assessment – completed in CTSC 5300 Epi I and at end of program • Mentor Assessments – annual • Course Evaluations • Graduate tracking – annual CVs Publications, grants, promotions, awards, patents, leadership and professional activities, etc.

23. Websites to know CCaTS Education Resources http://ctsa.mayo.edu/education/index.html • Quarterly Course Schedule • Program Milestones • New course listings • This presentation Mayo Graduate School http://mayoweb.mayo.edu/mgs/ • Quarterly course listing • Course Registration • Other required forms

24. “The research we do today will determine the type of medical and surgical practice we carry on at the Clinic tomorrow.” -William J. Mayo, M.D.

25. Questions