What is the Curriculum?

The components of the CITE program are divided equally between core content areas and mentored clinical research. The 30 credits leads to a Master of Science in Clinical Research. Besides didactic classes, there is substantial research (which will fulfill the thesis requirement) and training in scientific writing and grant preparation. The curriculum is designed to cover core competency areas through a combination of coursework and mentored research.

Master of Science in Clinical Research

Clinical Research Methods (3 credits)

This course covers the major types of study design (other than clinical trials) used in clinical research, including cohort, case-control, cross-sectional, survey, and secondary database studies. Fundamental themes in clinical research - and how to appropriately investigate them -are also addressed, such as diagnostic tests, therapy, etiology, and prognosis. Other topics include questionnaire design, meta-analysis, economic analysis, health status measurement, qualitative research, computerized searching, and health services and outcomes research.

Clinical Trials (3 credits)

This course covers core topics in conducting clinical trials, including design, recruitment, informed consent, randomization, blinding, data collection and analysis, safety monitoring, study closeout, and alternative designs such as cross-over and nonrandomized trials. Also, regulatory and special topics are covered including drug trials phase I through IV, patenting and other legal issues, institutional review boards, cancer trials, cells and human tissue, and trials involving special populations

Biostatistics (3 credits)

This course covers the use of computers and statistical software for data analyses, fundamental statistical concepts including probability and distributions, and application of parametric and nonparametric statistics on continuous and categorical data. Individuals who also want training in more complex statistical techniques, such as multivariate analysis and survival analysis, are encouraged to take a second course in biostatistics.

Research Ethics (2-3 credits)

This course provides an introduction to both the theory and practice of research ethics and covers the key ethical principles and concepts. Topics covered include the history of science and misconduct, mentoring and laboratory supervision, data management and ownership, human subjects research (including safety compliance), animal rights and welfare, research writing, authorship and mentorship, conflict of interest and industry relationships, intellectual property and copyright, and genetic technology.

Research Communication (2 credits)

This course combines a core didactic set of classes on the key elements of scientific writing along with the requirement for completion of a paper to be submitted for publication in a peer-reviewed journal. Two secondary skills are also covered. Manuscript review is addressed, including co-review of a manuscript with a mentor or other faculty scientist. The principles of presenting research at scientific meetings are also covered, including preparing an abstract, an oral presentation, and a poster.

Grant Writing (3 credits)

This course combines a core didactic set of classes along with the requirement for completion of a grant to be submitted for intramural or external funding. Topics covered include specific aims and hypotheses, background section and previous work, study design and methods, statistical analysis and sample size determination, budget preparation, and other special issues. Identifying federal and nonfederal funding sources will be addressed. Elements of a successful grant are further reinforced through grant review and mock study sections.

Mentored Clinical Research (7-9 credits)

This is an organized research project in the form of an organized scientific contribution or comprehensive analysis conducted under the mentorship of a faculty scientist from the individual CITE enrollee's core discipline. The capstone experience is submission of an abstract to a scientific meeting, defense of one's research before an Advisory Committee, and completion of a first-authored paper deemed suitable for publication in a scientific journal.

Electives (4-6 credits)

Example electives include graduate level courses in more advanced biostatistics, epidemiology, clinical pharmacology, genetics, molecular biology, and computer sciences. However, CITE enrollees may select electives from the entire offering of graduate courses at both Indiana University and Purdue University at Indianapolis as well as IU at Bloomington.

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What is the Time Commitment?

Because of the dual components - coursework leading to an M.S. degree and ongoing mentored clinical research - 70% time allocation to the CITE program for a two-year period is strongly recommended. This means that clinical, teaching, and administrative activities should typically not exceed 30% of one's time while participating in the program. The 70% time allocation will be about equally divided between formal coursework leading to the degree and mentored clinical research leading to at least one grant and one or more manuscripts for publication. Candidates considering a different model (such as having less than 70% protected time, or completing the program in a time frame longer than two years) should discuss this with the CITE Program Director. Exceptions will be considered on a case by case basis.

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What are the Resources and Environment for Clinical Research?

The State of Indiana has a population of over 5,000,000. Indiana University Medical Center acts as a primary care center for metropolitan Indianapolis with a population of about 800,000, the nation's 12th largest city. In 1997 University Medical Center comprising University Hospital with 332 beds, Riley Hospital for Children with 243 beds, and Methodist Hospital with 760 beds merged to form Clarian Health. In 1997 Clarian Health had more than 63,000 admissions, 350,000 total inpatient days and 950,000 total outpatient visits. In addition, Wishard Hospital has 470 beds, with 17,500 inpatient admissions and 165,000 outpatient visits each year. The Roudebush Veterans Administration Hospital has 175 beds and 60 nursing home beds, with nearly 6,000 inpatient admissions and 280,000 outpatient visits each year. Clarian Health acts as the major secondary and tertiary referral center for the State of Indiana.

The Indianapolis campus includes Indiana's only Medical and Dental Schools and the nation's largest Nursing School. The IU School of Medicine numbers approximately 1,100 medical students, as well as over 1,000 individuals pursuing graduate medical education, including interns, residents, and fellows. There are more than 370 students in the School of Dentistry and 650 students in the School of Nursing. The School of Allied Health Sciences includes more than 500 professional and 450 pre-professional students. Together, these IU health profession schools have over 1,200 full-time faculty.

The General Clinical Research Center (GCRC) is located on the fifth floor of University Hospital with offsite facilities in Neonatology and Gene therapy. It supports a large portion of the School of Medicine's NIH funded research in patients and on average has 150 active protocols. The School of Medicine receives over 100 million dollars of research funding each year, of which approximately two-thirds comes from the NIH. Besides hundreds of grants to individual investigators, there are 20 federally funded research centers or program projects, and another 14 supported by nonfederal grants. The IU School of Nursing receives 4 million dollars in grants for research and ranks 11th among nursing schools nationwide in federal funding. Local sources of research include the Research Investment Fund, Clarian Health, and the Indiana University Foundation. INGEN resources have recently been added with 6 programs and 9 cores in the field of genomics. Indiana University ranks 15th in the nation among all universities in private sector support and 13th in the nation among public universities in the value of its endowment.

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How is Mentorship Provided?

Mentorship in clinical research is an integral component of the CITE program in that the knowledge imparted through a formal curriculum is greatly enhanced by the practical skills attained in designing a project, preparing a grant, collecting and analyzing data, and publishing the results in a scientific journal. For most CITE participants, a mentor will be selected prior to enrollment, usually a faculty scientist from the enrollee's own discipline and area of research interest. The lead responsibility for identifying a mentor will reside with faculty in the CITE trainee's primary division, department, or research unit. Further assistance may be provided as needed by the CITE Program Director and Education Committee.

CITE trainees are expected to meet at least monthly with their primary mentor. Together, the CITE trainee and primary mentor will identify at least two other faculty scientists to serve on an Advisory Committee, which meets five times during the trainee's participation in the CITE program, at approximately 4-month intervals. The Advisory Committee oversees the trainee's progress, provides guidance and necessary support, evaluates the completion and quality of research, and offers ongoing career advice. The primary mentor chairs the Advisory Committee and forwards an evaluation report to the CITE Program Director following each Advisory Committee meeting The CITE Program Director also meets individually with each CITE trainee twice a year to discuss progress and needs as well as to solicit feedback.

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Can One Enroll in Individual Courses?

Participation in the full CITE program is strongly recommended for those planning a career in clinical research. In some cases, however, an individual may wish to enroll in only one or several courses. For certain courses, this may be on a space-available basis, so contacting the CITE Program Director (see below) is strongly recommended.

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What are the Costs of Participating in the CITE Program?

The major cost is the time commitment required for completion of the full program, which typically requires support by the head of the division, department or research unit in which the CITE trainee resides. Many CITE participants will have salary or stipend support funded by a fellowship, training grant, or junior faculty career award. Others will arrange for the necessary protected time with their supervisor with the express purpose and intent of building the research capacity and productivity of their division or department.

Tuition, fees, and books are the other cost of the program. Since most CITE enrollees will be clinical faculty or other employees of the university, fee courtesy will apply to approximately half of the necessary credit hours. For such enrollees, the typical costs will not exceed several thousand dollars. Many CITE enrollees will be supported by a research training grant or career award that funds tuition and training-related costs. In other cases, the trainee's division or department may subsidize these costs. A limited amount of funds are available in the CITE program itself to provide tuition support for some (but not all) of the program participants.

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