©2013 MFMER | slide-1 Educational Resources Center for Translational Science Activities Welcome Certificate Program Orientation April 30, 2013

©2013 MFMER | slide-2 Agenda Introductions CTSA Program Overview Certificate Requirements Research Proposal Scholar/Mentor Relationships Competencies Program Evaluations & Outcomes Questions

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©2013 MFMER | slide-4 Mayo Clinic Center for Translational Science Activities (CTSA) CTSA Research Resources (CRU) CTSA Community EngagementCTSA Community Engagement CTSA Consultative, Regulatory and Informatics Services CTSA Education Resources – David O. Warner, MD, Director Glenn E. Smith, PhD, LP, Associate Director CTSA Certificate Program – W. Ray Kim, MD, Director Shawna L. Ehlers, PhD, LP, Associate Director

©2013 MFMER | slide-5 CTSA 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

©2013 MFMER | slide-6 Certificate Program Expectations Find time for coursework: 1 hr. lecture = 2-4 hours outside work 1 credit = 48 hours/qtr or 4 hours/week 3 cr/qtr ~ 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

©2013 MFMER | slide-7 Certificate Program Requirements 12 didactic credits 7 required 5 electives “Writing for Biomedical Publications” workshop Research resulting in publication Manuscript & Mentor Summary Letter & CV

©2013 MFMER | slide-8 Coursework Required Courses: CTSC 5300 & 5310 Clinical Epidemiology I & II (1 cr each) CTSC 5600 Statistics in Clinical Research (2 cr) CTSC 5010 Clinical Research Protocol Development (2 cr) CORE 6000 Responsible Conduct of Research (1 cr) Courses available in-person and online Registration begins one month prior to each quarter Required: 7 credits begining either summer or winter quarter Electives: 5 credits of either CTSC or MGS courses Up to 3 graduate credits may be transferred – must relate to your project Mayo Graduate School Course InformationMayo Graduate School Course Information CTSA Annual Course Schedule Publication Workshop: March 6, 2014

©2013 MFMER | slide-9 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

©2013 MFMER | slide-10 Workshops  Required Workshop: Writing for Biomedical Publications March 6, 2014 ~ offered once per year only Available at all three sites (MCR, MCA, MCF) Registration Fee - $275 (fee waived)  Optional Workshop: Write Winning Grants November 8, 2013 ~ offered once per year only Available at all three sites (MCR, MCA, MCF) Registration Fee - $275 (fee waived)

©2013 MFMER | slide-11 Research Proposal Packet 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 Includes: Cover page Cover letter signed by you and your mentor Research proposal Division research committee approval IRB approval Submission cycle to CTSA approval is twice each year January or July only Early submissions are accepted

©2013 MFMER | slide-12 Program Timeline Research Proposal Packet – Due January 2, 2014 Writing Workshop – March 6, 2014 Progress Report – April 1, 2014Progress Report Coursework complete (3.0 GPA) – June, 2014 Manuscript & Mentor Summary Letter – June, 2014 Cite the Grant! Reviewed by Postdoctoral Committee If requirements have been fulfilled – Certificate is awarded!

©2013 MFMER | slide-13 Scholar and Mentor Relationships Expectations These are meant as a guide to help facilitate optimal scholar/mentor relationships. Contact CTSA if issues arise. 1)Initial Agreement – at time of application 2)Progress Report – submitted 2 months after research proposal is approved 3)Mentoring Effectiveness Assessment (Scholar & Mentor) – will be requested annually, spring quarter.

©2013 MFMER | slide-14 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 publication Effectively communicate research results through presentation

©2013 MFMER | slide-15 Competencies (cont.) Articulate and apply appropriate study designs Use appropriate biostatistical methods Understand the peer-review process Ability to navigate the peer-review process for grants and papers

©2013 MFMER | slide-16 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.

©2013 MFMER | slide-17 Websites to know CTSA Education Resources Quarterly Course Schedule Program Milestones New course listings This presentation Mayo Graduate School Quarterly course listing Course Registration Other required forms

©2013 MFMER | slide-18 “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.

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