CPXXXXXX-1 CTSA Education Resources “Educating a new generation of clinical investigators to bring discovery into practice”

CPXXXXXX-2 CTSA Master’s Degree New Scholar/Mentor Orientation Agenda December 6, 2012  Introductions  Scholar/Mentor Relationships  CTSA Program Overview  MS Requirements  Program Evaluation & Outcomes  Questions

CPXXXXXX-3 CTSA Executive Committee Robert A. Rizza, MD Mayo Clinic Director for Research CTSA Director and Principal Investigator David O. Warner, MD Mayo Clinic Associate Director for Clinical/Translational Research CTSA Associate Director and Co-PI Scott Kaese / Cheryl A. Nelson Administrators, Mayo Clinic Research Administrative Services CTSA Director / Associate Director of Administration Research Resources S. Khosla, MD Co-PI and Director Education Resources D. O. Warner, MD Co-PI and Director External Advisory Committee Internal Advisory Committee CTSA Academic Affairs Committee Community Engagement D. O. Warner, MD Co-PI and Director Pilot and Feasibility Research Resources Review Panel (RRRP) Scientific Review Panels Novel Methodology Community- Based Research Networks Translating Comparative Effectiveness Research into Practice (TRACER) Office for Community Engaged Research (OCER) Research Volunteer Resource (RVR) Predoctoral Programs Postdoctoral Programs Research Management Programs Clinical Research Unit (CRU) Saint Marys Charlton Mobile Medical Student Programs CTS Masters and Certificate Programs Translational Technology Cores (TTC) PhD & MD/PhD Program in CTS KL2 Mentored Career Devel Program Scholarly Opportunity Award Regulatory Support Research Ethics Resource Consultative, Regulatory, and Informatics Services R. D. Simari, MD Co-PI and Director Communications Continuous Professional Development Program Study Coordinator Degree and Diploma Programs Specialized Phenotyping Facilities Study Design and Biostatistics Biomedical Informatics Res. Subject Advocacy Services Research Information Center

CPXXXXXX-4  CTSA Reseach Resources CTSA Reseach Resources  CTSA Community Engagement CTSA Community Engagement  CTSA Service Center CTSA Service Center  CTSA Education Resources – David O. Warner, Director Glenn E. Smith, PhD, LP, Associate Director Mayo Clinic Center for Translational Science Activities (CTSA)

CPXXXXXX-5 Mayo Clinic Center for Translational Science Activities (CTSA) CTSA Education Resources Predoctoral Programs Postdoctoral Programs Certificate Program (CTSA) Master’s Degree (CTSA) KL2 Career Development Program Research Management Programs Continuing Professional Development Courses

CPXXXXXX-6  W. Ray Kim, M.D. Associate Director, Postdoctoral Programs  Katrin Frimannsdottir, Ph.D. Director of Program Evaluation  Karen Weavers – Operations Manager  Tauna Juengers – Operations Coordinator  Anne Bofferding – Curriculum Manager  Linda Wenner/Nicole Ramaker –Program Coordinators  Ashley Noelke– Administrative Assistant Postdoctoral Administrative Staff

CPXXXXXX-7 Postdoctoral Program Goals To train independent investigators to perform outstanding extramurally-funded patient-based research To enhance clinical research skills for Mayo faculty as a whole

CPXXXXXX-8 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

CPXXXXXX-9 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 See complete list of competencies on the CTSA web site.

CPXXXXXX-10 What does it take to gain these competencies? TIME Coursework (Each 1 hr of lecture requires 2-4 hours outside class) Write proposal Gather/analyze data Write thesis TIMELINE ON YOUR CALENDAR WRITING SKILLS (reviews/critiques, proposals, hypotheses, manuscripts PROJECT MANAGEMENT EFFORT MENTORING (Asking questions, incorporating feedback)

CPXXXXXX-11 Mentoring Scholar and Mentor Expectations These expectations are meant as a guide to help facilitate optimal scholar/mentor relationships. program/for-current-scholars/mentoring-expectations 1)Initial Agreement – at time of application 2)Detailed Agreement – to be discussed and completed with mentor and submitted with proposal by Jan. 2, 2013.Detailed Agreement 3)Mentoring Effectiveness Assessment (Scholar & Mentor) – will be requested annually, spring quarter.

CPXXXXXX-12 Scholar Expectations Clarify expectations of mentor's role and communicate mutually agreed expectations. Take the initiative and bring ideas to the table. Follow up with these ideas or suggestions of the mentor. Progress with their research and course work in a timely manner. Accept critical appraisals of their work. Communicate effectively and timely regarding progress and questions. Take responsibility and initiative for their career development. Meet with their mentor on a weekly basis to ensure progress. Provide useful and important content to the research program of the mentor. Perform at an acceptable level. Be first author on research publications. Exhibit mutual respect.

CPXXXXXX-13 Mentor Expectations Clarify expectations of scholar's role and communicate mutually agreed expectations. Meet with the scholar on a weekly basis to ensure progress. Provide opportunities for scholar's ideas and input. Provide critical appraisal of writing and presentation skills. Communicate effectively and timely regarding progress of research and papers. Provide guidance on career development. The scholar's research should provide useful and important content to your research. Provide for research costs and expenses related to successful completion of the thesis/certificate project. Exhibit mutual respect.

CPXXXXXX-14 Program Overview Postdoctoral Master’s Degree - MGS 1) Coursework/Degree Program Form: 24 credits GPA 2) Comprehensive Written Examination (full-day) 3) Research project resulting in a thesis (2-3 papers) 4) Thesis Advisory Committee/ Progress Reports 5) Final Oral Examination (thesis defense)

CPXXXXXX-15 1) Coursework - Required Courses (16 credits)  5010-Clinical Research Protocol Development (2)  5020-Regulatory Issues in Clinical Research (1)  6000-Responsible Conduct of Research (1)  Grant Writing Wksp – Nov. 9, 2012  Publication Wksp - Mar. 1, 2013  5300 & 5310-Clinical Epidemiology I & II (1 ea)  Advanced Applied Epidemiological Methods (2)  5600-Statistics in Clinical Research (2)  5601-Utilizing Statistics in Clinical Research (1)  5610-Introductory Stats Methods II (3)  5720-Clinical Trials: Design and Conduct (1)  5690-Critical Appraisal of Statistical Methods in the Medical Literature (1)

CPXXXXXX-16 Electives can be CTSC or any other MGS courses 25% of the credits can be transfer credits CTSA Required & Elective Credits Mayo Graduate School Catalog 2) Coursework – Elective Courses (8 credits)

CPXXXXXX-17 1) Coursework/Degree Program Form (DPF) – due Jan. 2, 2013  Submit with thesis proposal and Thesis Advisory Committee forms  Include courses completed and those you propose to take to fulfill degree requirements (24 credits total; 16 required)  Can transfer in up to 6 credits (25%)  Form on Mayo Graduate School Web site:

CPXXXXXX-18 2) Comprehensive Written Exam  Taken after completion of (14 cr): CTSC Protocol Development CTSC 5300 & Epi I & II CTSC Advanced Applied Epi (III) CTSC 5600 & Stats I & II CTSC Critical App of Stat Methods (III) CTSC Clinical Trials Design  Full day exam  January 15, April 16 or August 20 ( written-exam.html) written-exam.html

CPXXXXXX-19 3) Research Project Proposal – due Jan. 2, Proposal - submitted for CTSA approval by January 2, 2013 a.Proposal Format ( degree-program/for-current-scholars/research-requirements ) degree-program/for-current-scholars/research-requirements b.Feasible to complete within timeline indicated c.Can be submitted earlier for approval d.Utilize Protocol Development course for another project e.Include a definition of scholar’s role of in the project f.Note standards for thesis (2-3 original papers) 2.Notice of IRB Approval 3.Notice of divisional research committee approval 4.Detailed Mentoring Agreement Reviewed by CTSA Postdoc Committee using proposal review criteria (

CPXXXXXX-20 4) Thesis Advisory Committee (TAC) – due Jan. 2, 2013  Minimum of 4 members – RATP forms* Chair - usually primary mentor – only member who can also be co-investigator (exception for statistician) Members - need MGS Faculty Privileges (check MGS website) *Thesis Advisory Committee (TAC) Form: *Recommended Action on Thesis Protocol form:  TAC and scholar have defined roles and expectations  Oversees progress and quality of research project  Meet every 6 months to review progress of scholar Submit summary of Progress Meeting to CTSA  Becomes Final Oral Examining Committee at Thesis Defense

CPXXXXXX-21 Other Components  Required Workshops: Write Winning Grants Friday, November 9, 2012 Available at all three sites (MCR, MCA and MCF) Registration Fee - $ (fee waived) Registration deadline October 26, workshops.html#grantshttp://ctsa.mayo.edu/education/writing- workshops.html#grants Writing for Biomedical Publications Friday, March 1, 2013 Available at all three sites (MCR, MCA and MCF) Registration Fee - $ (fee waived) Registration deadline February 22, workshops.html#biomedicalhttp://ctsa.mayo.edu/education/writing- workshops.html#biomedical

CPXXXXXX-22 Final Oral Examination – Thesis Defense  After completion of all course work, Comprehensive Written Exam and approval of DPF, research proposal and TAC  Follow CTSA and MGS Thesis GuidelinesCTSAMGS Thesis Guidelines  Requires a minimum of THREE MONTHS for scheduling. Contact Linda Wenner/Nicole Ramaker to set preliminary thesis defense date  Six weeks prior to your anticipated defense date – Submit thesis draft for CTSA 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

CPXXXXXX-23 Degree Clearance - Completion  Review DPF with transcript  Grade point average of 3.0  Two Workshops - required Grant Writing – November 9, 2012 Publication – March 1, 2013  Comprehensive Written Examination  Research Proposal & TAC & Progress Reports  Final Oral Examination (thesis defense)  Current CV

CPXXXXXX-24 Graduation  Degrees conferred quarterly (requirements completed by first day of preceding month) August (July 1) November (Oct. 1) February (Jan. 1) May (Apr. 8)  Formal Graduation Ceremony – May ONLY For a May graduation – Thesis to CTSA by February 8 All requirements completed by April 8

CPXXXXXX-25 Evaluation Program Evaluation Activities CTRAI (Pre/Post self-assessment – in CTSC 5000 and at awarding of Degree) Mentor Assessments (annual) Course evaluations (each course) Graduate tracking (annual CVs) Publications, grants, promotions, awards, patents, leadership and professional activities, etc.

CPXXXXXX-26 Outcomes Career Development Awards (K Awards) Intra- or Extramural Funding Publications, Presentations Academic Rank and career promotion Research leadership & mentoring

CPXXXXXX-27 What’s NEW?  New Winter Qtr 2013 CTSC 5082 American Indian Health Disparities (online from Kansas University Medical Center) CTSC 5920 Introduction to Health Care Systems Engineering CTSC 6140 Epigenetics and Epigenomics  New Spring Qtr 2013 CTSC 5081 Advanced Topics in Health Disparities CTSC 5510 Genetic Epidemiology (new revision) CTSC 5960 Medical Informatics for the Clinical Researcher CTSC 5761 Evidence-Based Medicine for Clinical Researchers CTSC 5870 Social and Behavioral Foundations of Health

CPXXXXXX-28 Web sites to know: CTSA Education Resources Quarterly Course Schedule New course listings This presentation Mayo Graduate School Quarterly course listing Registration forms Other required forms

CPXXXXXX Dates to Remember: January 2, 2013: Degree Program Form (DPF) Thesis Advisory Committee Form (TAC) With a Recommended Action Form for each Member Research Proposal Cover letter signed by you & your mentor IRB Approval (or evidence of submission) Divisional Research Committee Approval Detailed Mentoring Agreement March 1, 2013 – Publishing Workshop August 1, 2013 – First Progress Report

CPXXXXXX-30 “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.

CPXXXXXX-31 Questions???