Courses with Semester & Time Requirements
(See Overview for Credits and other Requirements)
K30 PROGRAM YEAR ONE* |
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Summer B |
3 weeks of all-day classes in July |
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Course # |
Credits | Course Name | ||
GMS 6875 |
3 | Ethical & Regulatory Aspects of Clinical Research | ||
GMS 6840 |
2 | Cultural & Diversity Issues in Clinical Research | ||
GMS 6844 |
1 | Basic Principles of Patient-Oriented Research | ||
Fall |
Full Semester on-line courses |
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Course # |
Credits | Course Name | ||
PHC 6050 |
3 | Biostatistics (Web-based) | ||
PHC 6000 |
3 | Epidemiology (Web-based) Option: May be offered in class another semester |
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Spring |
2 weeks of half-day classes mid-Spring with 1 week break |
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Course # |
Credits | Course Name | ||
GMS 6841 |
1 | Fundamentals of Translational Research | ||
GMS 6843 |
2 | Scientific Communication | ||
K30 PROGRAM YEAR TWO* |
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Summer A |
4 days of 4 hr classes in one to two weeks in June |
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Course # |
Credits | Course Name | ||
GMS 6905 |
1 | Grantsmanship I | ||
Summer C |
Mid-May to Mid-July every Tu & Th 5:00-7:15 pm |
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Course # |
Credits | Course Name | ||
PHC 6020 |
3 | Design & Conduct of Clinical Trials | ||
Fall |
Every other week, Wed 3:00-5:00 pm |
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Course # |
Credits | Course Name | ||
GMS 6906 |
1 | Grantsmanship II | ||
Spring |
Every other week, Wed 3:00-5:00 pm |
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Course # |
Credits | Course Name | ||
GMS 6907 |
1 | Grantsmanship III | ||
*EXCEPTIONS to 2-YR Schedule of One-Time per Semester Required Core Course Offerings |
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Offered Every Semester |
Meets monthly on Wednesday 3-5 pm, plus mentor meetings |
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Course # |
Credits | Course Name | ||
GMS 6093 |
Variable | Clinical and Translational Mentored Research | ||
Every Other Year |
10 sessions of 90 minutes each, Fall and Spring -TBA |
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Course # |
Credits | Course Name | ||
GMS 6921 |
1+1 | Colloquium on Building a Successful Academic Career | ||
NOTE: Each scholar is required to identify and complete a Graduate Level Basic Science Course |
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Course Descriptions
GMS 6875 Ethical & Regulatory Aspects of Clinical Research (3 credits):Summer B-alternate calendar (1st year)
Core components of training in the responsible conduct of research and professional ethics, which have been defined by the NIH Office of Research Integrity, National Academy of Sciences Institute of Medicine, Association of American Medical Colleges, and other scientists and ethicists are used as the core of this course. The major topics covered include: history of international agreements on ethics of human research; data acquisition, management, sharing, and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; human subjects; studies involving genetic information or gene therapy; use of human tissues and samples in research; stem cell research; research involving animals; research misconduct; conflicts (real and apparent) of interest; confidentiality and HIPAA requirements. In addition to classroom time, there is required attendance to observe deliberations of the Institutional Review Board, Scientific Review Committee; Protocol Monitoring Committee, and Institutional Animal Care and Use Committee.
GMS 6840 Cultural & Diversity Issues in Clinical Research (2 credits):Summer B-alternate calendar (1st year)
One purpose of this course is to encourage the trainees to have a clear understanding of the rationales, and to make it a strong priority, to include the broadest population possible in clinical and translational research studies. Attitudes, language, and cultural differences that create misunderstandings and may inhibit participation of underserved and disadvantaged individuals in clinical research will be addressed. Diversity in clinical research subjects is discussed in its broad sense to include diversity of races, ethnic groups, gender, age, disease status, and co-morbidities that is reasonable and is thought to be safe. The rationales of gaining the greatest knowledge about effectiveness and safety of new drugs and drug combinations in the broadest populations of patients possible and of the necessity of serving all of the diverse populations of patients nationally and internationally will be emphasized. The second major purpose of this course is to introduce trainees to principles and methods of conducting research into how cultural, racial, and socioeconomic differences influence overall health status, health care access, health care utilization, compliance with recommended medical care, acceptance of treatment, differential access to treatments, responsiveness to treatment, offers of participation in clinical research, and willingness to participate in clinical research.
GMS 6844 Basic Principles of Patient-Oriented Research (1 credit):Summer B-alternate calendar (1st year)
This course is designed to be an introduction to the principles, approaches and challenges to conducting clinical and translational research. Students are exposed to how to the construct valid clinical therapeutic studies at all stages from phase I through phase IV, how to conceive, design and conduct population-based clinical studies, the role of meta-analyses in determining best medical practices, how the drug discovery process works, how to interact properly and productively with biotechnology and pharmaceutical companies to conduct patient-oriented research, how to relate basic science research findings to developing and conducting clinical research studies, how to incorporate the translational research aspects into the overall scheme of a clinical study, how to identify the kinds and sources of support needed to engage in studies with patients, and how to construct a clinical and translational research training and career development plan and specific research plan within the context of a grant application.
PHC 6050 Biostatistics I (3 credits):Fall (1st year) (Web-based)
This course provides trainees with an understanding of the basic information on statistical applications to basic, clinical, and population-based research, which is required for them to conduct solid, valid research studies and to interact intelligently with (but not to be) biostatisticians.
PHC 6000 Epidemiology (3 credits):Fall (1st year) (Web-based)
The study of epidemiological methods to evaluate the patterns and determinants of health and disease in populations. Option: This course may be offered as in class one semester per year.
GMS 6841 Fundamentals of Translational Research (1 credit):Spring (1st year) Alternate Sched.
The purpose of this course is to educate the students on how to consider basic research principles and hypotheses when designing clinical and translational research studies, interacting productively with basic scientists in creating superior translational research projects, principles of pharmacokinetics and pharmacodynamics, incorporation of biological markers and endpoints in clinical research studies, and understanding of modern types of biological tests that are available through core facilities or in the research laboratories of basic scientists and which may have relevance to clinical studies.
GMS 6843 Scientific Communication (2 credits):Spring (1st year) Alternate Schedule
The purpose of this course is to develop and improve written and verbal communication skills of trainees, which are essential for their career development. These skills include preparation of research abstracts, presentations of abstracts orally and as posters; preparation of manuscripts describing basic research, clinical and translational research, population studies, review articles and book chapters; determination of most appropriate journals for submission of manuscripts; electronic submission of manuscripts and abstracts; manuscript review process; how to respond to major and minor criticisms/suggestions from reviewers; resubmission of revised manuscripts; organizing and presenting research work at lab meetings; organizing and presenting research work in seminar formats; PowerPoint slide preparation skills. Trainees make oral presentations in front of the group, critique their own and others’ presentations, and participate in projects on writing and reviewing abstracts and manuscripts.
GMS 6905 Grantsmanship I & GMS 6906 Grantsmanship II & GMS 6907 Grantsmanship III (3 credits):1 credit (2nd Summer) Alternate Schedule; 1 credit (2nd Fall); 1 credit (2nd Spring)
The purpose of this course is to teach the principles of preparation of grant applications and grant management to trainees who have little or no experience in these processes and the skills that are necessary for success. This course consists of a combination of web-based and classroom presentations and individual and group exercises. The main thrust is a systematic approach to practical aspects of structuring and writing career development and research grant applications. Other closely related topics covered include: major types of grants (training, career development, individual research projects, program projects, SPORE and SCORE-type grants, center grants, contracts, special grants and supplements available for underserved minorities, loan repayment grants, foundation grants, pharmaceutical and biotechnology industry grants); mechanics of grant handling, review and funding processes at NIH; interactions with NIH or foundation administrative staff; mock peer-review study section meeting; how to respond effectively to critiques of an unfunded grant proposal; budgeting; managing grants financially and scientifically; progress reports; competing renewals; individual and interactive group trainee assignments for various stages of grant preparation; interactive sessions to critique the trainees’ model grant applications. Those topics that are most relevant to the beginning investigator are emphasized. All students are required to prepare a grant application in the format for submission to NIH for either a career development grant (K-type awards) or research grant (R-type awards).
PHC 6017 Design and Conduct of Clinical Trials (3 credits): Summer C (2nd year)
The course familiarizes students with the issues in the design and conduct of clinical trials. Factors involved in organizing a trial, randomizing subjects, implementation, and analyzing data from the study are considered.
GMS 6921 Colloquium on Building a Sucessful Academic Patient-Oriented Research Career (2 credits total): Offered every other academic year for 1 credit (2nd Fall); 1 credit (2nd Spring)
Seminars are presented by faculty members who are at various stages of development of a successful academic career in patient-oriented research. Guest speakers from other institutions, pharmaceutical companies, and government also will present seminars on patient-oriented research careers in the private sector and in government. The goal of this seminar series is to expose trainees to the various career opportunities that exist and strategies that are useful in developing a successful career in patient-oriented research.
MS 6093 Clinical and Translational Mentored Research (variable up to 3 cr per semester by agreement with rersearch mentor) Offered each semester upon submission of required form on K30 website under “Mentored Research”.
The Clinical and Translational Mentored Research course is designed to facilitate and provide continuous feedback and guidance for the mentored research efforts of the students in the graduate concentration of clinical and translational patient-oriented research in the Medical Sciences program of USF Health. Regular meetings between the program director and course participants, in addition to the meetings with their research mentors, will supplement and support the research efforts of the students by providing a continuing independent review of research plans, monitoring of progress, and evaluation of problems as they arise so that each of the students advances to successful completion of their project. The course includes reference readings on various aspects of clinical research, along with exercises the beginning student can use to assess their own level of understanding, both for their own project and for reading and assessing the applicability of published articles relevant to their topic of research. The meetings will require presentations by the students and feedback and input by the other students, as well as by program faculty with expertise pertaining to the area of research being conducted.
of Interest
Centers/Institutes