Career Advancement Program for Clinical Research Scholars (CAPS) ORIENTATION TBS
Opening Remarks Russell V. Luepker, MD, MS Mayo Professor  Division of Epidemiology & Community Health School of Public He...
NIH Roadmap and  CAPS Program Overview Russell V. Luepker, MD, MS Mayo Professor  Division of Epidemiology & Community Hea...
NIH Roadmap Goal Goal of K12 NIH Roadmap: ...to educate future leaders of multidisciplinary clinical research and speed th...
NIH Roadmap Re-engineering the Clinical Research  Enterprise Research Teams of the Future New Pathways to Discovery
<ul><li>Difficulty recruiting and retaining clinical researchers </li></ul><ul><li>Rising overhead costs and regulatory de...
Challenges of Interdisciplinary Research <ul><li>The current system of academic advancement favors the independent investi...
Multidisciplinary Clinical Research Career Development Program <ul><li>Roadmap K12 Program is designed to increase the nat...
CAPS Program Goals <ul><li>CAPS is more than a training program. </li></ul><ul><li>Goals: </li></ul><ul><li>to train clini...
CAPS Overview <ul><li>Minnesota’s Approach </li></ul><ul><li>Core Competencies </li></ul><ul><li>Training Program </li></u...
Minnesota’s Approach <ul><li>Faculty Career Development    Program </li></ul><ul><li>Executive Committee </li></ul><ul><li...
CAPS Core Competencies <ul><li>Study concepts </li></ul><ul><li>Study designs </li></ul><ul><li>Multidisciplinary collabor...
Training Program <ul><li>MS in Clinical Research or related field </li></ul><ul><li>Additional CAPS courses and seminars <...
Training Program (cont’d) MS Clinical Research (38 cr) <ul><li>Fundamentals of Clinical Research (3 cr) </li></ul><ul><li>...
Training Program (cont’d) Other Master’s Level Degrees <ul><li>MS in Health Services Research and Policy </li></ul><ul><li...
CAPS Expectations <ul><ul><li>Commit 75% effort to CAPS-related training, research, and career development activities (50%...
Career Advancement Program for Clinical Research Scholars (CAPS) Introductions
CAPS 2008 Scholars <ul><li>Scholar:   Aviva Abosch, MD, PhD, Assistant Professor, Neurosurgery </li></ul><ul><li>Mentors: ...
CAPS 2008 Scholars <ul><li>Scholar:   Jason Baker, MD, MS, Assistant Professor, Infectious Diseases & International Medici...
CAPS 2008 Scholars <ul><li>Scholar:   Monica Colvin-Adams, MD, Assistant Professor, Cardiology </li></ul><ul><li>Mentors: ...
CAPS 2008 Scholars <ul><li>Scholar:   Sean Elliott, MD, Assistant Professor, Urologic Surgery </li></ul><ul><li>Mentors:  ...
CAPS 2008 Scholars <ul><li>Scholar:   Lynda Polgreen, MD, MS, Fellow, Pediatric Endocrinology </li></ul><ul><li>Mentors:  ...
CAPS 2008 Scholars <ul><li>Scholar:   Steven Stovitz, MD, Assistant Professor, Family Medicine and Community Health; Adjun...
CAPS 2008 Scholars <ul><li>Scholar:   Fareed Suri, MD, Fellow, Neurology </li></ul><ul><li>Mentors:   Aaron R. Folsom, MD,...
CAPS 2006 Scholars <ul><li>Scholar:   Lisa Chow, MD, Assistant Professor, Endocrinology </li></ul><ul><li>Mentors:  Elizab...
CAPS 2006 Scholars <ul><li>Scholar:  Kamakshi Lakshminarayan, MD, Assistant Professor, Neurology </li></ul><ul><li>Mentors...
CAPS 2006 Scholars Scholar:   Daniel A Mulrooney, MD, MS, Assistant Professor, Pediatrics; Pediatric Hematology, Oncology,...
CAPS 2006 Scholars Scholar:   Heather E. Vezina, PharmD, Assistant Professor, Laboratory Medicine and Pathology/Experiment...
CAPS 2007 Scholars Scholar:   David R. Boulware, MD, Assistant Professor, Infectious Diseases & International Medicine Men...
CAPS 2007 Scholars <ul><li>Scholar:   Melissa A. Geller, MD, Assistant Professor, Obstetrics, Gynecology and Women's Healt...
CAPS 2007 Scholars <ul><li>Scholar:   Ken M. Kunisaki, MD, MS, Assistant Professor, Pulmonary, Allergy, Critical Care, and...
CAPS 2007 Scholars <ul><li>Scholar:   Jeffrey R. Wozniak, PhD, LP, Assistant Professor, Psychiatry </li></ul><ul><li>Mento...
CAPS Executive Committee Russell V. Luepker, MD, MS, Mayo Professor,  Epidemiology & Community Health, SPH CAPS Program Di...
CAPS  Multidisciplinary Advisory Committee <ul><li>Russell V. Luepker, MD, MS (Chair) </li></ul><ul><li>Linda H. Bearinger...
CAPS Ombudsman <ul><li>David M. Brown, MD, Professor Emeritus, Pediatrics/Laboratory Medicine and Pathology </li></ul><ul>...
CAPS & the CTSA ?
CAPS Mentoring and Evaluation CAPS Mentoring & Evaluation Director
CAPS Mentoring & Evaluation <ul><li>Why the emphasis on mentoring in this program </li></ul><ul><li>What do we know about ...
Why Emphasis on Mentoring? <ul><li>Faculty with mentors demonstrate higher levels of success on the following factors:   <...
Not all Mentoring is alike <ul><li>Effective faculty mentoring is a result of: </li></ul><ul><ul><li>Clarity of purpose </...
CAPS Mentoring Teams <ul><li>Mentoring teams include experienced clinical investigators </li></ul><ul><li>Teams are multid...
Mentoring Workshops <ul><li>Mentoring Workshop: </li></ul><ul><li>Scholars attend an initial mentoring workshop with their...
First Mentoring Workshop for  Mentors and Mentees   <ul><li>Working session to review: </li></ul><ul><ul><li>Mentee’s care...
Workshop for Mentors Only   <ul><li>Working session </li></ul><ul><ul><li>to review highlights of Scholars’ progress </li>...
Online Tracking of  Mentoring and Career Development (Optional) Matt Beecher, Informatics Manager,  General Clinical Resea...
CAPS Scholar Agreement <ul><li>Requirement:  </li></ul><ul><li>75% effort on CAPS-related training, research, and career d...
CAPS Scholar Agreement <ul><li>Expectations (continued): </li></ul><ul><ul><li>Participate in all CAPS-specific activities...
CAPS Mentor Agreement <ul><li>Requirement:   </li></ul><ul><li>Assure that scholars spend 75% effort on CAPS-related train...
CAPS Mentor Agreement <ul><li>Expectations (continued): </li></ul><ul><li>Approve career development plan components and s...
CAPS Baseline and Year-End Quantitative Evaluation <ul><li>Evaluation </li></ul><ul><li>Data collection at the beginning o...
Baseline Evaluation Forms <ul><li>Evaluation is a CAPS requirement </li></ul><ul><li>Baseline forms - complete and return ...
CAPS Scholar  Qualitative Evaluation <ul><li>At 6 months, 1 year, and then annually, a MAC Evaluation Subcommittee reviews...
Biostatistician Mentors in CAPS James D. Neaton, PhD, MS Professor, Division of Biostatistics, School of Public Health CAP...
Biostatistician Mentors: General Goals <ul><li>Work with you and the other mentors as part of a multi-disciplinary team </...
Biostatistician Collaborators Will Work With You To: <ul><li>Formulate study questions </li></ul><ul><li>Develop study imp...
 
CAPS Benefits & Administration Russell V. Luepker, MD, MS CAPS Program Director
CAPS Benefits <ul><li>Salary and Benefits - commensurate with rank and position (75% effort; 50% for surgical scholars) </...
Benefits Administration <ul><li>Salary  </li></ul><ul><li>Salary is paid through scholars’ departments </li></ul><ul><li>(...
Benefits Administration  (continued) <ul><li>Travel </li></ul><ul><li>Complete CAPS Travel Authorization (TA) form (on CAP...
Benefits Administration  (continued) <ul><li>Research Funds </li></ul><ul><li>Complete Research Funding Application (on CA...
Benefits Administration  (continued) <ul><li>Mentor Funds </li></ul><ul><li>Review policy re use of mentor funds (on Mento...
MS Program Application <ul><li>Submit choice of MS program to CAPS Program Director for approval </li></ul><ul><li>Apply t...
Public Information <ul><li>Scholar’s name </li></ul><ul><li>Photo </li></ul><ul><li>Biosketch </li></ul><ul><li>Area of st...
Notification of Changes <ul><li>Scholars are required to immediately notify  </li></ul><ul><li>CAPS Director in writing of...
Leaves of Absence <ul><li>Requires written request to CAPS Program Director </li></ul><ul><li>Requires approval of CAPS Pr...
Clinical Research Shared Support Office of Clinical Research: budget, study staff, clinic space Biostatistics Core: study ...
CAPS Contacts
Introductions EpiCH Support Staff
CAPS Coordinator   Terri Tharp, MPH [email_address] 612-626-8882
MS Clinical Research  Major Coordinator Andrea Kish, MS [email_address]
EpiCH Accounting Keith Coyer CAPS Accountant [email_address]
Administrative Support Jill Anderson Administrative Specialist [email_address] Janelle Willard Executive Secretary [email_...
CAPS Questions? CAPS Program Director Russell V. Luepker, MD, MS [email_address] CAPS Co-Director Elizabeth R. Seaquist, M...
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K12 Eligibility

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  • a single PI is recognized; indirect costs from collaborating institutions become embedded in direct costs of the “lead” institution indirect costs follow the PI.
  • K12 Eligibility

    1. 1. Career Advancement Program for Clinical Research Scholars (CAPS) ORIENTATION TBS
    2. 2. Opening Remarks Russell V. Luepker, MD, MS Mayo Professor Division of Epidemiology & Community Health School of Public Health CAPS Program Director
    3. 3. NIH Roadmap and CAPS Program Overview Russell V. Luepker, MD, MS Mayo Professor Division of Epidemiology & Community Health School of Public Health CAPS Program Director
    4. 4. NIH Roadmap Goal Goal of K12 NIH Roadmap: ...to educate future leaders of multidisciplinary clinical research and speed the translation of research discoveries into improved patient care.
    5. 5. NIH Roadmap Re-engineering the Clinical Research Enterprise Research Teams of the Future New Pathways to Discovery
    6. 6. <ul><li>Difficulty recruiting and retaining clinical researchers </li></ul><ul><li>Rising overhead costs and regulatory demands </li></ul><ul><li>Limitations due to NIH funding mechanisms, review, and program structure </li></ul><ul><li>Lack of a viable career pathway deters investigators from conducting clinical and translational research – impedes basic research results from entering into clinical practice </li></ul>How Did We Get Here?
    7. 7. Challenges of Interdisciplinary Research <ul><li>The current system of academic advancement favors the independent investigator </li></ul><ul><li>Most institutions house scientists in discrete departments </li></ul><ul><li>Interdisciplinary science requires interdisciplinary peer-review </li></ul><ul><li>Project management and oversight is currently performed by discrete ICs </li></ul><ul><li>Interdisciplinary research teams take time to assemble and require unique resources </li></ul>
    8. 8. Multidisciplinary Clinical Research Career Development Program <ul><li>Roadmap K12 Program is designed to increase the national pool of clinician-scientists from many disciplines </li></ul><ul><li>The program differs in its goal by supporting career development of the clinical research team </li></ul><ul><li>The clinical research team includes: nurses, sociologists, pharmacologists, biostatisticians, and epidemiologists, in addition to physicians, dentists, and other scientists. </li></ul><ul><li>Funding for up to 5 years includes didactic and practical training in design, conduct, and analysis of clinical research </li></ul><ul><li>Each clinical research scholar may be recruited from within a grantee institution or externally and has two mentors </li></ul>
    9. 9. CAPS Program Goals <ul><li>CAPS is more than a training program. </li></ul><ul><li>Goals: </li></ul><ul><li>to train clinical researchers </li></ul><ul><li>to launch Scholars’ careers </li></ul><ul><li>to increase the number of interdisciplinary researchers who are working together </li></ul>
    10. 10. CAPS Overview <ul><li>Minnesota’s Approach </li></ul><ul><li>Core Competencies </li></ul><ul><li>Training Program </li></ul><ul><li>Expectations </li></ul><ul><li>Scholars & Mentoring Teams </li></ul><ul><li>MAC </li></ul><ul><li>Shared Resources </li></ul><ul><li>Ombudsman </li></ul>
    11. 11. Minnesota’s Approach <ul><li>Faculty Career Development Program </li></ul><ul><li>Executive Committee </li></ul><ul><li>Multidisciplinary Scholars </li></ul><ul><li>Mentoring Teams </li></ul><ul><li>Infrastructure Support </li></ul><ul><li>Research Support </li></ul><ul><li>Evaluation </li></ul><ul><li>Upper Midwest Consortium </li></ul>
    12. 12. CAPS Core Competencies <ul><li>Study concepts </li></ul><ul><li>Study designs </li></ul><ul><li>Multidisciplinary collaboration </li></ul><ul><li>Research funding </li></ul><ul><li>Planning and managing research studies </li></ul><ul><li>Human Subjects Protection and Responsible Conduct of Research </li></ul><ul><li>Data collection, management, & analysis </li></ul><ul><li>Data interpretation </li></ul><ul><li>Reporting study findings (publications) </li></ul><ul><li>Professional presentation of study results </li></ul>
    13. 13. Training Program <ul><li>MS in Clinical Research or related field </li></ul><ul><li>Additional CAPS courses and seminars </li></ul><ul><ul><li>Career Development seminar (PubH 6309) </li></ul></ul><ul><ul><li>AHC Clinical Research Conference </li></ul></ul><ul><ul><li>Management for Clinical Research (PubH 6572) </li></ul></ul><ul><li>NIH CTSA KL2/K12 Annual Meeting </li></ul><ul><li>Midwest Consortium </li></ul>
    14. 14. Training Program (cont’d) MS Clinical Research (38 cr) <ul><li>Fundamentals of Clinical Research (3 cr) </li></ul><ul><li>Epidemiologic Methods I & II (3 cr each) </li></ul><ul><li>Biostatistics I & II (4 cr each) </li></ul><ul><li>Clinical Trials (3 cr) </li></ul><ul><li>Clinical Research Project Seminar (2 cr) </li></ul><ul><li>Writing Research Grants (2 cr) </li></ul><ul><li>Ethics in Public Health: Res & Policy (1 cr) </li></ul><ul><li>Thesis Credits: Master’s (10 cr) </li></ul><ul><li>Electives (3 cr) </li></ul>
    15. 15. Training Program (cont’d) Other Master’s Level Degrees <ul><li>MS in Health Services Research and Policy </li></ul><ul><li>MS in Clinical Investigation </li></ul><ul><li>MS in Social, Administrative, and Clinical Pharmacy - Experimental and Clinical Pharmacology Track </li></ul><ul><li>MPH in Epidemiology </li></ul>
    16. 16. CAPS Expectations <ul><ul><li>Commit 75% effort to CAPS-related training, research, and career development activities (50% effort for surgical scholars). </li></ul></ul><ul><ul><li>Commit no more than 25% total effort to clinical duties, teaching, and departmental administrative duties. </li></ul></ul><ul><ul><li>Post and update Career Development Plan, Ground rules, Confidentiality Agreement, and Mentoring Team interactions on mentor team website. </li></ul></ul><ul><ul><li>Meet regularly with mentoring team. </li></ul></ul><ul><ul><li>Participate in all CAPS-specific activities (seminar, conferences, workshops, etc). </li></ul></ul><ul><ul><li>Complete MS degree program (if not completed prior to CAPS). </li></ul></ul><ul><ul><li>Register for additional CAPS-specific courses. </li></ul></ul><ul><ul><li>Submit one peer-review article for publication per year (exceptions granted for full-time MS program students in first K12 year) </li></ul></ul><ul><ul><li>Presentations </li></ul></ul><ul><ul><li>Grant proposal (by end of CAPS period) </li></ul></ul>
    17. 17. Career Advancement Program for Clinical Research Scholars (CAPS) Introductions
    18. 18. CAPS 2008 Scholars <ul><li>Scholar: Aviva Abosch, MD, PhD, Assistant Professor, Neurosurgery </li></ul><ul><li>Mentors: Apostolos P. Georgopoulos, MD, PhD, Professor, Neuroscience; Jon E. Grant, MD, MPH, Associate Professor, Psychiatry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Lynn E. Eberly, PhD, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: Compulsive Behavior in Patients with Parkinson’s Disease before and after Deep Brain Stimulation </li></ul>
    19. 19. CAPS 2008 Scholars <ul><li>Scholar: Jason Baker, MD, MS, Assistant Professor, Infectious Diseases & International Medicine, HCMC </li></ul><ul><li>Mentors: James D. Neaton, PhD, Professor, Biostatistics; W. Keith Henry, MD, Professor, UMN AIDS Clinical Trials Unit, HCMC; Richard Grimm, MD, PhD, MPH, Professor, Cardiology/ Epidemiology; Daniel A. Duprez, MD, PhD, Professor, Cardiology </li></ul><ul><li>Project Title: Small and Large Arterial Elasticity and HIV Infection: a pilot study </li></ul>
    20. 20. CAPS 2008 Scholars <ul><li>Scholar: Monica Colvin-Adams, MD, Assistant Professor, Cardiology </li></ul><ul><li>Mentors: Daniel J. Garry, MD, PhD, Professor, Cardiology; </li></ul><ul><li>Daniel A. Duprez, MD, PhD, Professor, Cardiology; Robert F. Wilson, MD, Professor, Cardiology; John E. Connett, PhD, Professor and Head, Biostatistics; Robert Bache, MD, Professor, Cardiology </li></ul><ul><li>Project Title: Phosphodiesterase-5 Inhibition and Cardiac Allograft Vasculopathy </li></ul>
    21. 21. CAPS 2008 Scholars <ul><li>Scholar: Sean Elliott, MD, Assistant Professor, Urologic Surgery </li></ul><ul><li>Mentors: Timothy J. Wilt, MD, MPH, Professor, Internal Medicine; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration; Robert L. Kane, MD, Professor, Health Policy and Management; Roger Feldman, PhD, Professor, Health Policy and Management; Bradley P. Carlin, PhD, MS, Mayo Professor, Biostatistics </li></ul><ul><li>Project Title: The influence of financial incentives on practice patterns and outcomes in prostate cancer therapy </li></ul>
    22. 22. CAPS 2008 Scholars <ul><li>Scholar: Lynda Polgreen, MD, MS, Fellow, Pediatric Endocrinology </li></ul><ul><li>Mentors: Anna Petryk, MD, Assistant Professor, Pediatric Endocrinology; Antoinette M. Moran, MD, Professor, Pediatrics; Chester B. Whitley, MD, PhD, Professor, Pediatrics; William Thomas, PhD, MS, Associate Professor, Biostatistics </li></ul><ul><li>Research Project : To study bone health in two related populations: children after hematopoietic cell transplantation (HCT) and children with Mucopolysac-charidosis (MPS) diseases with and without HCT and/or enzyme replacement therapy (ERT) </li></ul>
    23. 23. CAPS 2008 Scholars <ul><li>Scholar: Steven Stovitz, MD, Assistant Professor, Family Medicine and Community Health; Adjunct Faculty, Kinesiology </li></ul><ul><li>Mentors: Robert W. Jeffrey, PhD, Professor, Epidemiology and Community Health; John H. Himes, PhD, Professor, Epidemiology and Community Health; Mark A. Pereira, PhD, Associate Professor, Epidemiology and Community Health; Peter J. Hannan, MStat, Senior Research Fellow, Epidemiology and Community Health </li></ul><ul><li>Research Project: To study childhood growth features which predict adult obesity utilizing the CATCH and SOLAR databases </li></ul>
    24. 24. CAPS 2008 Scholars <ul><li>Scholar: Fareed Suri, MD, Fellow, Neurology </li></ul><ul><li>Mentors: Aaron R. Folsom, MD, MPH, Professor, Epidemiology and Community Health; Adnan I. Qureshi, MD, Professor, Neurology; Cavan S. Reilly, PhD, MS, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: Renin-Angiotensin System Polymorphisms and Risk of Small Vessel Ischemic Stroke – Analysis from a Cardiovascular Cohort </li></ul>
    25. 25. CAPS 2006 Scholars <ul><li>Scholar: Lisa Chow, MD, Assistant Professor, Endocrinology </li></ul><ul><li>Mentors: Elizabeth R. Seaquist, MD, Professor, Medicine; </li></ul><ul><li>Michael Garwood, PhD, Professor, Radiology; </li></ul><ul><li>Lynn E. Eberly, PhD, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy </li></ul><ul><li>Scholar: Sarah A. Cooley, MD, Assistant Professor, Adult Hematology, Oncology and Transplantation </li></ul><ul><li>Mentors: Jeffrey S. Miller, MD, Professor, Medicine; </li></ul><ul><li>Daniel J. Weisdorf, MD, Professor, Hematology, Oncology and Transplantation; Chap T. Le, PhD , Distinguished Professor, Biostatistics </li></ul><ul><li>Project Title: Natural Killer Cell Receptors </li></ul>
    26. 26. CAPS 2006 Scholars <ul><li>Scholar: Kamakshi Lakshminarayan, MD, Assistant Professor, Neurology </li></ul><ul><li>Mentors: David C. Anderson, MD, Professor, Neurology; </li></ul><ul><li>Russell V. Luepker, MD, MS, Mayo Professor, Epidemiology & Community Health; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration; </li></ul><ul><li>David R. Jacobs, Jr., PhD, Professor, Epidemiology & Community Health </li></ul><ul><li>Project Title: Improving Evidence-Based Quality of Care in Acute Stroke </li></ul><ul><li>Scholar: Peter Milev, MD, PhD, Assistant Professor, Psychiatry </li></ul><ul><li>Mentors: Kelvin O. Lim, MD, Professor, Psychiatry; </li></ul><ul><li>Angus W. MacDonald III, PhD, Assistant Professor, Psychology; Susanne S. Lee, PhD, Assistant Professor and Statistician, Psychiatry </li></ul><ul><li>Project Title: Deficits in perceptual organization and thought disorder in schizophrenia: relationships with fMRI functional anatomy </li></ul>
    27. 27. CAPS 2006 Scholars Scholar: Daniel A Mulrooney, MD, MS, Assistant Professor, Pediatrics; Pediatric Hematology, Oncology, Blood and Marrow Transplantation Mentors: Joseph P. Neglia, MD, MPH, Professor, Pediatrics; Robert P. Hebbel, MD, Professor, Hematology, Oncology and Transplantation; James D. Neaton, PhD, Professor, Biostatistics Project Title: Atherosclerosis in Survivors of Childhood and Young Adult Hodgkin’s Disease Scholar: Marcie R. Tomblyn, MD, MS, Assistant Professor, Hematology, Oncology and Transplantation Mentors: Daniel J. Weisdorf, MD, Professor, Hematology, Oncology and Transplantation; Mary M. Horowitz, MD, Professor, Medicine, Medical College of WI; John P. Klein, PhD, Professor, Biostatistics, Medical College of WI; Brent R. Logan, PhD, Assistant Professor, Biostatistics, Medical College of WI Research Project: To design and execute local and multi-center trials to advance hematopoietic stem cell transplant (HSCT) for management of lymphoma
    28. 28. CAPS 2006 Scholars Scholar: Heather E. Vezina, PharmD, Assistant Professor, Laboratory Medicine and Pathology/Experimental and Clinical Pharmacology Mentors: Henry H. Balfour, Jr., MD, Professor, Lab Medicine and Pathology/Pediatrics; Richard Brundage, PharmD, PhD, Associate Professor, Pharmacy; William Thomas, PhD, Associate Professor, Biostatistics Project Title : Pharmacokinetic and pharmacodynamic characteristics of valacyclovir (V-ACV) in adults with primary Epstein-Barr virus (EBV) infectious mononucleosis (IM)
    29. 29. CAPS 2007 Scholars Scholar: David R. Boulware, MD, Assistant Professor, Infectious Diseases & International Medicine Mentors: Paul R. Bohjanen, MD, PhD, Associate Professor, Microbiology and Medicine; Edward N. Janoff, MD, Professor, Infectious Diseases, University of Colorado at Denver; James D. Neaton, PhD, MS, Professor, Biostatistics; Tracy L. Bergemann, PhD, Assistant Professor, Biostatistics Project Title: Immune Reconstruction Syndrome in HIV-infected Persons in Resource-Limited Areas Scholar: Adam F. Carpenter, MD, Assistant Professor, Neurology Mentors: Apostolos P. Georgopoulos, MD, PhD, Professor, Neuroscience; Gareth J. Parry, MD, Professor, Neurology; Kelvin O. Lim, MD, Professor, Psychiatry; Lynn E. Eberly, PhD, Associate Professor, Biostatistics Project Title: Protein markers of disease in Multiple Sclerosis (MS)
    30. 30. CAPS 2007 Scholars <ul><li>Scholar: Melissa A. Geller, MD, Assistant Professor, Obstetrics, Gynecology and Women's Health </li></ul><ul><li>Mentors: Amy P. N. Skubitz, PhD, Associate Professor, Laboratory Medicine and Pathology; Sundaram Ramakrishnan, PhD, Professor, Pharmacology; Douglas Yee, MD, Professor, Hematology, Oncology and Transplantation; Chap T. Le, PhD, Professor, Biostatistics </li></ul><ul><li>Project Title: Neoadjuvant Chemotherapy in Ovarian Cancer: Predicting Tumor Response </li></ul><ul><li>Scholar: L’Aurelle A. Johnson, PhD, Assistant Professor, Experimental & Clinical Pharmacology </li></ul><ul><li>Mentors: Timothy S. Tracy, PhD, Professor, Pharmacy; </li></ul><ul><li>Pamala A. Jacobson, PharmD, Associate Professor, Pharmacy; </li></ul><ul><li>Julie A. Ross, PhD, Professor, Pediatrics; Antoinette M. Moran, MD, Professor, Pediatrics; Melanie M. Wall, PhD, MS, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: The effect of childhood obesity on phase 1 and phase 2 drug metabolism enzymes </li></ul>
    31. 31. CAPS 2007 Scholars <ul><li>Scholar: Ken M. Kunisaki, MD, MS, Assistant Professor, Pulmonary, Allergy, Critical Care, and Sleep Medicine </li></ul><ul><li>Mentors: Dennis E. Niewoehner, MD, Professor, Pulmonary Section, VAMC; Allen S. Levine, PhD, Professor and Dean, College of Food, Agricultural and Natural Resources Sciences; John E. Connett, PhD, Professor and Head, Biostatistics </li></ul><ul><li>Project Title: Micronutrients and Exacerbations of COPD </li></ul><ul><li>Scholar: Donald R. Nixdorf, DDS, MS, Assistant Professor, Diagnostic & Biological Sciences, Dentistry </li></ul><ul><li>Mentors: Eric L. Schiffman, DDS, MS, Associate Professor, Dentistry; David A. Bereiter, PhD, Professor, Dentistry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Noam Harel, PhD, Assistant Professor, Medicine; James S. Hodges, PhD, MA, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: Functional Imaging of Trigeminal Neuropathic Pain </li></ul>
    32. 32. CAPS 2007 Scholars <ul><li>Scholar: Jeffrey R. Wozniak, PhD, LP, Assistant Professor, Psychiatry </li></ul><ul><li>Mentors: Kelvin O. Lim, MD, Professor, Psychiatry; Monica A. Luciana, PhD, Associate Professor, Psychology; Pi-Nian Chang, PhD, Associate Professor, Pediatrics/Psychiatry; Paul M. Thuras, PhD, Research Associate, Psychiatry </li></ul><ul><li>Project Title: Cerebral white matter effects of fetal alcohol exposure: A Diffusion Tensor Imaging (DTI) study of microstructural brain abnormalities and their neurocognitive correlates </li></ul><ul><li>Scholar: Fang Yu, PhD, RN, Assistant Professor, Adult and Gerontological Health Co-operative Unit, Nursing </li></ul><ul><li>Mentors: Jean F. Wyman, PhD, RN, FAAN, FGSA, Professor, Nursing Research/Community Health and Family Practice; </li></ul><ul><li>Maurice W. Dysken, MD, Professor, Psychiatry; Wei Pan, PhD, Associate Professor, Biostatistics </li></ul><ul><li>Project Title: The FIT-AD Study / Preserving Cognition and Function Through Aerobic Training in Alzheimer's Disease </li></ul>
    33. 33. CAPS Executive Committee Russell V. Luepker, MD, MS, Mayo Professor, Epidemiology & Community Health, SPH CAPS Program Director Elizabeth R. Seaquist, MD, Interim Director, OCR; Professor, Medicine; Director, GCRC; CAPS Co-Director James D. Neaton, PhD, Professor, Biostatistics, SPH CAPS Co-Director
    34. 34. CAPS Multidisciplinary Advisory Committee <ul><li>Russell V. Luepker, MD, MS (Chair) </li></ul><ul><li>Linda H. Bearinger, PhD, MS, RN, FAAN </li></ul><ul><li>David M. Brown, MD, Ombudsman </li></ul><ul><li>Barbara A. Elliott, PhD </li></ul><ul><li>Frank A. Lederle, MD </li></ul><ul><li>Bryan S. Michalowicz, DDS, MS </li></ul><ul><li>James D. Neaton, PhD </li></ul><ul><li>Nancy C. Raymond, MD </li></ul><ul><li>Timothy W. Schacker, MD </li></ul><ul><li>S. Charles Schulz, MD </li></ul><ul><li>Elizabeth R. Seaquist, MD </li></ul><ul><li>William Thomas, PhD, MS </li></ul><ul><li>Timothy S. Tracy, PhD </li></ul><ul><li>Todd M. Tuttle, MD, MS </li></ul><ul><li>Anne Marie Weber-Main, PhD </li></ul><ul><li>Daniel J. Weisdorf, MD </li></ul>
    35. 35. CAPS Ombudsman <ul><li>David M. Brown, MD, Professor Emeritus, Pediatrics/Laboratory Medicine and Pathology </li></ul><ul><li>Role of Ombudsman </li></ul><ul><li>• to provide scholars with feedback and advice </li></ul><ul><li>from outside the program </li></ul><ul><li>• to facilitate resolution of program-related difficulties and challenges </li></ul>
    36. 36. CAPS & the CTSA ?
    37. 37. CAPS Mentoring and Evaluation CAPS Mentoring & Evaluation Director
    38. 38. CAPS Mentoring & Evaluation <ul><li>Why the emphasis on mentoring in this program </li></ul><ul><li>What do we know about effective mentoring </li></ul><ul><li>How the CAPS program facilitates an effective mentoring approach </li></ul><ul><li>How the CAPS program evaluated </li></ul>
    39. 39. Why Emphasis on Mentoring? <ul><li>Faculty with mentors demonstrate higher levels of success on the following factors: </li></ul><ul><ul><li>Research productivity (Bland and Schmitz 1986, Byrne and Keefe 2002) </li></ul></ul><ul><ul><li>Professional socialization and interactions with colleagues (Corcoran and Clark 1984) </li></ul></ul><ul><ul><li>Salary levels; and satisfaction with salary and promotion (Melicher 2000) </li></ul></ul><ul><ul><li>Teaching effectiveness, evidenced by declines in teaching anxiety and improved student ratings of teaching effectiveness (Williams 1991). </li></ul></ul>
    40. 40. Not all Mentoring is alike <ul><li>Effective faculty mentoring is a result of: </li></ul><ul><ul><li>Clarity of purpose </li></ul></ul><ul><ul><li>Systematic tasks and activities that the mentor and mentee do together – not personal chemistry </li></ul></ul><ul><ul><li>Early and enduring mentoring is most beneficial </li></ul></ul><ul><ul><li>Regular meetings of the mentoring pairs/teams - which may require “nudging” </li></ul></ul><ul><ul><li>Using mentors from outside the mentee’s department is very effective </li></ul></ul><ul><li>(Boyle and Boice, 1998) </li></ul>
    41. 41. CAPS Mentoring Teams <ul><li>Mentoring teams include experienced clinical investigators </li></ul><ul><li>Teams are multidisciplinary and include a biostatistician </li></ul><ul><li>Mentors responsibilities are clearly delineated </li></ul><ul><li>Mentoring process and development of mentees is reviewed regularly </li></ul><ul><li>Mentors and mentees participate in training workshops </li></ul><ul><li>Online tracking of mentoring process (meetings and progress) is provided </li></ul>
    42. 42. Mentoring Workshops <ul><li>Mentoring Workshop: </li></ul><ul><li>Scholars attend an initial mentoring workshop with their senior mentors and, preferably, one or more associate mentors. </li></ul><ul><li>Mentor-to-Mentor Workshop: </li></ul><ul><li>Senior Mentors attend a mentors-only workshop to provide feedback on the mentoring experience. </li></ul><ul><li>Dates are posted on the CAPS Website as workshops are scheduled. </li></ul><ul><li>Next Mentoring Workshop (new Scholars & Mentors): </li></ul><ul><li>Friday, June 6, 2008 from 1:00-4:00 p.m. </li></ul><ul><li>at 142 WBOB </li></ul>
    43. 43. First Mentoring Workshop for Mentors and Mentees <ul><li>Working session to review: </li></ul><ul><ul><li>Mentee’s career vision, goals, next year’s objectives, and activities </li></ul></ul><ul><ul><li>Mentee’s incoming strengths and improvement areas </li></ul></ul><ul><ul><li>Mentoring ground rules and confidentiality agreements </li></ul></ul><ul><ul><li>Mentoring schedule (team is expected to meet as a group at least quarterly) </li></ul></ul><ul><ul><li>Role of each mentor on the team </li></ul></ul>
    44. 44. Workshop for Mentors Only <ul><li>Working session </li></ul><ul><ul><li>to review highlights of Scholars’ progress </li></ul></ul><ul><ul><li>to review Scholars’ time distribution </li></ul></ul><ul><ul><li>to discuss mentoring team roles (individual and group as a whole) </li></ul></ul><ul><ul><li>to review Scholars’ satisfaction with mentoring behaviors </li></ul></ul><ul><ul><li>to review adequacy of mentoring interactions </li></ul></ul><ul><ul><li>to discuss purpose of multidisciplinary mentoring and how best to achieve it </li></ul></ul><ul><ul><li>to share strategies for successful mentoring </li></ul></ul><ul><ul><li>to assess reasonableness of Scholars’ next year’s goals and timelines </li></ul></ul><ul><ul><li>to identify ways CAPS can better support mentoring activities. </li></ul></ul>
    45. 45. Online Tracking of Mentoring and Career Development (Optional) Matt Beecher, Informatics Manager, General Clinical Research Center <ul><li>Post career vision, goals, planned strategies, and timeline </li></ul><ul><li>Post ground rules and confidentiality agreement documents </li></ul><ul><li>Document mentor team meetings </li></ul><ul><li>Document use of Shared Clinical Research Support Group (SCRSG) </li></ul><ul><li>Note decisions from meetings, assignments before next meeting, and goals for next meeting </li></ul><ul><li>Maintain drafts of projects accessible by whole team </li></ul><ul><li>Ease mentor tracking burden </li></ul><ul><li>Aid evaluation without duplication of effort </li></ul>
    46. 46. CAPS Scholar Agreement <ul><li>Requirement: </li></ul><ul><li>75% effort on CAPS-related training, research, and career development activities (50% surgical scholars) </li></ul><ul><li>Expectations: </li></ul><ul><ul><li>Career development plan (post on team website within 2 wks of Mentoring Workshop; update 2 wks prior to scheduled MAC review meetings) </li></ul></ul><ul><ul><li>Ground rules and confidentiality agreements (post on team website w/in 2 wks of Mentoring Workshop) </li></ul></ul><ul><ul><li>Regularly scheduled mentoring team meetings (post schedule and interactions on mentor team website - post meetings and action items w/in 2 wks of each interaction) </li></ul></ul>
    47. 47. CAPS Scholar Agreement <ul><li>Expectations (continued): </li></ul><ul><ul><li>Participate in all CAPS-specific activities </li></ul></ul><ul><ul><li>Complete MS degree program (if not completed prior to CAPS) - 9-14 cr in first year; maintain 3.5 GPA </li></ul></ul><ul><ul><li>Register for additional CAPS-specific courses (all scholars) </li></ul></ul><ul><ul><li>Peer-review articles (1 per yr - exceptions granted to full-time students in first year) </li></ul></ul><ul><ul><li>Presentations </li></ul></ul><ul><ul><li>Grant proposal (by end of CAPS period) </li></ul></ul>
    48. 48. CAPS Mentor Agreement <ul><li>Requirement: </li></ul><ul><li>Assure that scholars spend 75% effort on CAPS-related training, research, and career development activities (50% effort for surgical scholars) </li></ul><ul><li>Expectations: </li></ul><ul><li>Attend CAPS Orientation and mentoring workshops </li></ul><ul><li>Participate in regularly scheduled mentoring team meetings </li></ul><ul><li>Senior Mentor provides accountability for scholar’s work and coordination of team - plans meeting agendas with Scholar to address research and career mentoring topics </li></ul><ul><li>Complete written mentoring ground rules and confidentiality agreements with scholar </li></ul><ul><li>Assist scholar with career development plan components including annual goals and objectives with specific strategies and timeline </li></ul>
    49. 49. CAPS Mentor Agreement <ul><li>Expectations (continued): </li></ul><ul><li>Approve career development plan components and subsequent changes (posted on mentor team website) </li></ul><ul><li>Monitor scholar’s career development, CAPS activities, and mentoring interactions - review team website entries monthly </li></ul><ul><li>Assure that scholar is receiving support and resources from home department </li></ul><ul><li>Provide information for semi-annual program evaluation of mentoring activities </li></ul><ul><li>Develop plans for grant submission </li></ul><ul><li>Benefits: </li></ul><ul><li>Mentor funds for CAPS-related activities including travel, continuing education, CAPS research project support, or salary redistribution </li></ul>
    50. 50. CAPS Baseline and Year-End Quantitative Evaluation <ul><li>Evaluation </li></ul><ul><li>Data collection at the beginning of the program and abbreviated follow-up at the end of each year as well as ongoing mentoring tracking: </li></ul><ul><ul><li>Scholar Clinical Research Appraisal Inventory </li></ul></ul><ul><ul><li>Scholar Department/Division Culture </li></ul></ul><ul><ul><li>Scholar Discipline Identification </li></ul></ul><ul><ul><li>Mentor Discipline Identification </li></ul></ul><ul><ul><li>Scholar and Mentor Consent form </li></ul></ul>
    51. 51. Baseline Evaluation Forms <ul><li>Evaluation is a CAPS requirement </li></ul><ul><li>Baseline forms - complete and return to CAPS Administrative Specialist (forms are posted on CAPS website) </li></ul><ul><li>Consent form - grants permission to use evaluation data for research purposes </li></ul>
    52. 52. CAPS Scholar Qualitative Evaluation <ul><li>At 6 months, 1 year, and then annually, a MAC Evaluation Subcommittee reviews: </li></ul><ul><ul><li>Clinical Schedule (protected time) </li></ul></ul><ul><ul><li>Overall Weekly Schedule (time management) </li></ul></ul><ul><ul><li>MS Degree Program </li></ul></ul><ul><ul><li>Current Research </li></ul></ul><ul><ul><li>Career Development </li></ul></ul><ul><ul><li>Mentoring Team Interactions </li></ul></ul><ul><ul><li>Connections in Professional Field </li></ul></ul><ul><ul><li>Use of Shared Resources </li></ul></ul><ul><ul><li>Overall CAPS Satisfaction </li></ul></ul><ul><ul><li>Completion of Evaluation Forms </li></ul></ul><ul><ul><li>Clinical Research Skills Development </li></ul></ul>
    53. 53. Biostatistician Mentors in CAPS James D. Neaton, PhD, MS Professor, Division of Biostatistics, School of Public Health CAPS Co-Director
    54. 54. Biostatistician Mentors: General Goals <ul><li>Work with you and the other mentors as part of a multi-disciplinary team </li></ul><ul><li>Learn about your field and area of research </li></ul><ul><li>Advise/teach biostatistical topics relevant to your research </li></ul><ul><li>Convey the value of early biostats mentor involvement re project design, data collection, and problem resolution </li></ul><ul><li>Discuss potential role of biostatistician mentors on future grants </li></ul>
    55. 55. Biostatistician Collaborators Will Work With You To: <ul><li>Formulate study questions </li></ul><ul><li>Develop study implementation plans </li></ul><ul><li>Interpret data </li></ul><ul><li>Determine the next question </li></ul>
    56. 57. CAPS Benefits & Administration Russell V. Luepker, MD, MS CAPS Program Director
    57. 58. CAPS Benefits <ul><li>Salary and Benefits - commensurate with rank and position (75% effort; 50% for surgical scholars) </li></ul><ul><li>Tuition and program application fee for up to 14 cr/sem and 6 cr/summer session </li></ul><ul><li>Travel funds for annual NIH-sponsored CTSA/K12 Meeting for Scholars , Upper Midwest Consortium meeting, and professional meetings (up to $2,500/year) </li></ul><ul><li>Research funds (up to $25,000 per year) </li></ul><ul><li>Mentor funds (up to $10,000 per year/team) </li></ul><ul><li>CAPS Award is renewable annually (3-5 years) </li></ul>
    58. 59. Benefits Administration <ul><li>Salary </li></ul><ul><li>Salary is paid through scholars’ departments </li></ul><ul><li>(departments cross charge K12 grant) </li></ul><ul><li>Tuition </li></ul><ul><li>Full tuition coverage for scholars in MS programs (e-mail Student Accts Receivable page to CAPS Coordinator each semester) </li></ul><ul><li>Scholars not in MS program apply for Regents Scholarship (non-degree student information and form are posted on CAPS website) </li></ul><ul><li>Required course textbooks and software are covered by CAPS (SAS forms on CAPS website) </li></ul>
    59. 60. Benefits Administration (continued) <ul><li>Travel </li></ul><ul><li>Complete CAPS Travel Authorization (TA) form (on CAPS website) & submit to CAPS Coordinator prior to travel </li></ul><ul><li>Check GSA per diem when completing TA (link posted on CAPS website) </li></ul><ul><li>Complete Employee Expense Worksheet (on CAPS website) and submit with original receipts after travel (internet charges are not allowed by K12 grant) </li></ul>
    60. 61. Benefits Administration (continued) <ul><li>Research Funds </li></ul><ul><li>Complete Research Funding Application (on CAPS website) </li></ul><ul><li>Complete NIH budget and justification </li></ul><ul><li>Contact Coordinator re equipment order forms </li></ul><ul><li>Submit forms electronically to the CAPS Coordinator with IRB approval/renewal letter </li></ul><ul><li>Include electronic signatures or send a signed hard copy to CAPS Coordinator at EpiCH, 300 WBOB </li></ul><ul><li>For subsequent year renewal requests, submit NIH budget and justification electronically and the most recent IRB approval/renewal letter </li></ul>
    61. 62. Benefits Administration (continued) <ul><li>Mentor Funds </li></ul><ul><li>Review policy re use of mentor funds (on Mentoring page of CAPS website) </li></ul><ul><li>Each Scholar’s team decides how to divide funds </li></ul><ul><li>Mentor funds may be used for professional travel, continuing education, CAPS research project, or salary redistribution </li></ul><ul><li>Submit forms to the CAPS Coordinator as early in each budget year as possible </li></ul>
    62. 63. MS Program Application <ul><li>Submit choice of MS program to CAPS Program Director for approval </li></ul><ul><li>Apply to program (see SPH website and Graduate Studies Coordinator for information) </li></ul><ul><li>Attend the SPH Orientation </li></ul><ul><li>Maintain contact with Major Coordinator and Advisor </li></ul><ul><li>Refer to Student Guidebook throughout program </li></ul><ul><li>Register for course load as outlined in plan </li></ul><ul><li>Maintain cumulative GPA of 3.5 </li></ul>
    63. 64. Public Information <ul><li>Scholar’s name </li></ul><ul><li>Photo </li></ul><ul><li>Biosketch </li></ul><ul><li>Area of study and research interest </li></ul><ul><li>Disclosed in press releases, program reports, web pages, and similar documents </li></ul>
    64. 65. Notification of Changes <ul><li>Scholars are required to immediately notify </li></ul><ul><li>CAPS Director in writing of: </li></ul><ul><li>Changes that preclude meeting award requirements </li></ul><ul><li>Acceptance of similar award with duplicate benefits </li></ul><ul><li>Changes in course load </li></ul><ul><li>Changes in clinical responsibilities </li></ul><ul><li>Changes in teaching load </li></ul><ul><li>Withdrawal from degree program </li></ul>
    65. 66. Leaves of Absence <ul><li>Requires written request to CAPS Program Director </li></ul><ul><li>Requires approval of CAPS Program Director </li></ul><ul><li>Maximum, if approved, is 2 months of unpaid absence </li></ul>
    66. 67. Clinical Research Shared Support Office of Clinical Research: budget, study staff, clinic space Biostatistics Core: study design, coordination, analysis GCRC: study staff, clinic space Clinical Pharmacology Center: pharmacokinetic and pharmacodynamic studies; pharmacogenetics Mentoring Core: guidelines, training, mentoring issues Scientific Writing Core: grant writing, manuscript preparation and review, presentations IRB: Human Subjects protection, informed consent issues IND/IDE Assistance Program: FDA/IND applications, FDA and industry-related issues Office of General Counsel: legal assistance, negotiating agreements, policy guidance CAPS Website: caps.umn.edu contacts, CR-related links, announcements, forms
    67. 68. CAPS Contacts
    68. 69. Introductions EpiCH Support Staff
    69. 70. CAPS Coordinator Terri Tharp, MPH [email_address] 612-626-8882
    70. 71. MS Clinical Research Major Coordinator Andrea Kish, MS [email_address]
    71. 72. EpiCH Accounting Keith Coyer CAPS Accountant [email_address]
    72. 73. Administrative Support Jill Anderson Administrative Specialist [email_address] Janelle Willard Executive Secretary [email_address]
    73. 74. CAPS Questions? CAPS Program Director Russell V. Luepker, MD, MS [email_address] CAPS Co-Director Elizabeth R. Seaquist, MD [email_address] CAPS Co-Director James D. Neaton, PhD jim@ccbr.umn.edu CAPS Mentoring and Evaluation Director TBN CAPS Coordinator Terri Tharp, MPH [email_address] CAPS Website www.caps.umn.edu

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