1. ©2013 MFMER | slide-1 Educational Resources Center for Clinical and Translational Science Welcome Master’s Program Orientation

2. ©2013 MFMER | slide-2 Agenda Introductions CCaTS Program Overview Master’s Requirements Research Proposal Scholar/Mentor Relationships Competencies Program Evaluations & Outcomes Questions

3. ©2013 MFMER | slide-3 Communications Research Resources Sundeep Khosla, MD PI and Director Community Engagement Victor Montori, MD Co-PI and Director Education Resources David Warner, MD Co-PI and Director Consultative, Regulatory and Informatics Services Rickey Carter, PhD Christopher Chute, MD Richard Sharp, PhD Internal Advisory Committee External Advisory Committee Mayo Clinic Center for Clinical and Translational Science (CCaTS) Intramural Awards Program Translational Technology Cores Pre-doctoral Programs Post-doctoral Programs Research Team Education Practice- Based Research Networks Translating Comparative Effectiveness Research into Practice Office for Community Engaged Research Study Design and Biostatistics Research Subject Advocacy Services Clinical Research Units Biomedical Informatics Research Ethics Program Research Information Center Regulatory Support Consortia Development Robert Rizza, MD Co-PI and Director Sundeep Khosla, MD CCaTS Director and Principal Investigator Scott Kaese, MBA CCaTS Director of Administration Laura Meiners, MBA CCaTS Operations Manager Drug Discovery and Development Andrew Badley, MD Co-PI and Director Specialized Phenotyping Facilities Midwest Area Research Consortium for Health (MARCH) University of Minnesota CTSI Sanford Burnham Medical Research Institute Jane Welter, MBA CCaTS Associate Director of Administration Late Stage Translational Research Victor Montori, MD Co-PI and Director University of Mississippi Medical Center Dartmouth-Synergy CCTS

4. ©2013 MFMER | slide-4 Mayo Clinic Center for Clinical and Translational Science (CCaTS) CCaTS Research Resources (CRU) CCaTS Community EngagementCCaTS Community Engagement CCaTS Consultative, Regulatory and Informatics ServicesCCaTS Consultative, Regulatory and Informatics Services CCaTS Education Resources – David O. Warner, MD, Director Glenn E. Smith, PhD, LP, Associate Director

5. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-10 Required Coursework CTSC 5300, 5310 and 5390 Clinical Epidemiology (4 cr 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) CTSC 5020 Regulatory Issues (1 cr) CTSC 5690 Critical Appraisal (1 cr) CTSC 5720 Clinical Trials (1 cr) Mayo Graduate School Course InformationMayo Graduate School Course Information CCaTS Annual Course ScheduleCCaTS Annual Course Schedule

11. ©2013 MFMER | slide-11 Potential Elective Courses 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 Clinical Trials Behavioral Individualized Medicine Healthcare Delivery

12. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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 CriteriaResearch 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. ©2013 MFMER | slide-14 Thesis Advisory Committee (TAC ) (due with proposal, January or July 1) Minimum of 4 members – 1)Thesis Advisory Committee (TAC) FormThesis Advisory Committee (TAC) Form 2)Recommended Action on Thesis Protocol FormRecommended 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 CCaTSProgress Report Meetings Becomes Examining Committee at Thesis Defense

15. ©2013 MFMER | slide-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 siteMaster’s Degree Program Form

16. ©2013 MFMER | slide-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 3 rd Thursday of January, April or August

17. ©2013 MFMER | slide-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 and MGS Thesis GuidelinesMGS 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. ©2013 MFMER | slide-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 thereafterProgress Report Coursework complete (3.0 GPA) Written Comprehensive Exam – 3 rd Thursday of January, April and August only Thesis submission to CCaTS Final Oral Examination

19. ©2013 MFMER | slide-19 Scholar and Mentor Relationships Expectations These are meant as a guide to help facilitate optimal scholar/mentor relationships. Contact CCaTS if issues arise. 1)Initial Agreement – at time of application 2)Progress Report – submit 6 months after research proposal is approved and every 6 months thereafterProgress Report 3)Mentoring Effectiveness Assessment (Scholar & Mentor) – will be requested annually, spring quarter.

20. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-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. ©2013 MFMER | slide-25