Welcome
Master’s Program Orientation
Center for
Clinical and Translational Science
Educational Resources
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Agenda
• Introductions
• CCaTS Program Overview
• Master’s Requirements
• Research Proposal
• Scholar/Mentor Relationships
• Competencies
• Program Evaluations & Outcomes
• Questions
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Mayo Clinic Center for Clinical and Translational Science (CCaTS)
Sundeep Khosla, MD
CCaTS Director and Principal Investigator
Scott Kaese, MBA
CCaTS Director of Administration
Jane Welter, MBA
CCaTS Associate Director of Administration
Laura Meiners, MBA
CCaTS Operations Manager
Drug Discovery and
Development
Research
Resources
Andrew Badley, MD
Co-PI and Director
Sundeep Khosla, MD
PI and Director
Sanford Burnham
Medical Research
Institute
Translational
Technology
Cores
Specialized
Phenotyping
Facilities
Clinical
Research
Units
Late Stage
Translational
Research
Victor Montori, MD
Co-PI and Director
Translating
Comparative
Effectiveness
Research into
Practice
Community
Engagement
Victor Montori, MD
Co-PI and Director
Office for
Community
Engaged
Research
PracticeBased
Research
Networks
Consultative,
Regulatory and
Informatics Services
Education
Resources
Consortia
Development
Rickey Carter, PhD
Christopher Chute, MD
Richard Sharp, PhD
David Warner, MD
Co-PI and Director
Robert Rizza, MD
Co-PI and Director
Study Design and
Biostatistics
Pre-doctoral
Programs
Research Ethics
Program
Post-doctoral
Programs
Midwest Area
Research
Consortium
for Health (MARCH)
Biomedical
Informatics
Regulatory
Support
Research Subject
Advocacy Services
Research
Team Education
University of
Minnesota CTSI
University of
Mississippi
Medical Center
Dartmouth-Synergy
CCTS
Research
Information
Center
Internal Advisory Committee
External Advisory Committee
Communications
Intramural Awards Program
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Mayo Clinic
Center 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
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Postdoctoral Administrative Staff
• 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
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CCaTS Postdoctoral Program
Goal:
To train clinicians to participate in intramurallyand extramurally-funded patient-based research.
The Social Contract of Medical Research
(discovering and applying knowledge to improve
health) is a privilege.
AAMC-GREAT Group
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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
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Master’s Program Expectations
• Find time for coursework:
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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
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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
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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 Information
• CCaTS Annual Course
Schedule
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Potential Elective Courses
Clinical Trials
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CTSC 5640 Logistic Regression
CTSC 5650 Survival Analysis
CTSC 5720 Clinical Trials: Design & Conduct
MPET 6820 Regenerative Medicine
Behavioral
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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
Individualized
Medicine
Healthcare
Delivery
• BMB 8350 Intro to Bioinformatics
• CTSC 5140 Epigenetics and Epigenomics
• CTSC 5660 Design analysis & App of Bioinformatics
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CTSC
CTSC
CTSC
CTSC
CTSC
5960 Medical Informatics
5760 Medical Decision Making
5761 Evidence Based Medicine for Clinical Researchers
5910 Economic Evaluation in Health Care
5940 Secondary Data Analysis
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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)
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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:
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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
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Thesis Advisory Committee (TAC)
(due with proposal, January or July 1)
• Minimum of 4 members –
1) Thesis Advisory Committee (TAC) Form
2) Recommended Action on Thesis Protocol Form
• TAC and scholar have defined roles and expectations
• Chair - usually primary mentor – only member who can also be coinvestigator (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
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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
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Comprehensive Written Exam
• Taken after completion of (14 cr):
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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
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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 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
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Program Timeline
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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
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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 thereafter
3) Mentoring Effectiveness Assessment (Scholar &
Mentor) – will be requested annually, spring
quarter.
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Competencies
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Critically evaluate clinical/translational research in the
medical literature
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Articulate the ethical & legal responsibilities of an
investigator
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Develop feasible and testable hypotheses
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Design and conduct a clinical/translational research
project
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Write competitive grant proposals
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Effectively communicate research results through
publications and presentation
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Competencies (cont.)
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Articulate and apply appropriate study designs
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Use appropriate bio-statistical methods
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Understand the peer-review process
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Ability to navigate the peer-review process for grants
and papers
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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.
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Websites to know
CCaTS Education Resources
http://ctsa.mayo.edu/education/index.html
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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
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“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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