General Medical Sciences


The Division of General Medical Sciences was established in 1986 to provide an organizational home for units pursuing interdisciplinary research and education objectives. The division is the equivalent of an academic department, and its constituent units are characterized as Centers.  The Dean of the School of Medicine serves as the Chair of the division; each Center is led by a director.  The unique nature of each of the General Medical Sciences centers is described in the paragraphs below.  (Centers are listed in alphabetical order by full title, and associated academic programs including certificate, MS and PhD programs described in top navigation tabs).

Case Comprehensive Cancer Center

Phone: 216.844.8797
http://cancer.case.edu
Stanton L. Gerson, MD, Director, Case Comprehensive Cancer Center

The Case Comprehensive Cancer Center (Case CCC) based at Case Western Reserve University (CWRU) is a partnership organization supporting cancer-related research efforts at CWRU, University Hospitals Cleveland Medical Center, and Cleveland Clinic. Located in Cleveland, Ohio, the Case CCC serves the cancer research and clinical needs of an urban manufacturing and rural agricultural region containing over 4 million people in Northern Ohio.

The Case CCC provides a unique forum and academic network for cancer researchers across our community to accomplish more than they may individually. Through the Case CCC, our medical institutions are linked in a stronger and more unified effort to understand the causes and progression of cancer and to use that understanding to develop treatments and to reduce the likelihood that our population will develop cancer and suffer from its consequences. The Cancer Center advocates for cancer research support across the institutions; provides funding for promising pilot grants, shared resource development, training programs, and recruitments; and catalyzes multidisciplinary and transdisciplinary cancer research across institutions, emphasizing innovative discovery that will have an impact on cancer patients.

The mission of the Case CCC is to:

  • Improve the prevention, diagnosis and therapy of cancer through discovery, evaluation and dissemination.
  • Stimulate and support innovative, coordinated interdisciplinary clinical research on cancer diagnosis, treatment, prevention and control.
  • Develop clinical applications of discovery and make these available to Northern Ohio residents as quickly as possible through the integrated efforts of the major health systems in the region.
  • Develop cancer prevention and control activities that build on the expertise of the Center and result in a reduction of cancer morbidity and mortality in Northern Ohio and the nation.

The research efforts of the Case CCC members are organized into seven interdisciplinary scientific programs. The clinical research effort is supported by 12 Clinical Trials Disease Teams that develop and prioritize clinical trials, and a single Protocol Review and Monitoring System, Data Safety and Monitoring Plan integrate cancer research, cancer therapeutics, and prevention services at the partner institutions and throughout the region.

Research programs of the Case CCC are also extending into community medical centers operated by University Hospitals and Cleveland Clinic. Outreach programs for clinical practice-based prevention and screening initiatives, educational programs, minority recruitment, and facilitation of patient referrals are also supported by the partner institutions.

In addition to successfully competing for a Cancer Center Support Grant from the National Cancer Institute, the Center must meet specific criteria for:

  • Breadth and depth of basic cancer research; clinical cancer research; and prevention, control and population/behavioral sciences research in cancer; and
  • Strength of interaction among these three major research areas.

The Case Comprehensive Cancer Center is one of only 50 NCI-designated Comprehensive Cancer Centers in the nation. Learn more about the National Cancer Institute’s Cancer Centers program at cancercenters.cancer.gov.

Center for Clinical Investigation

Phone: 216.368.3286
James Spilsbury, PhD, Academic Development Core Director

The Center for Clinical Investigation (CCI) was founded in 2007 and is part of Case Western Reserve University School of Medicine’s Division of General Medical Sciences.  The CCI serves as the academic home of Cleveland’s Clinical & Translational Science Collaborative, a partnership of 4 local institutions (Case Western Reserve University, the Cleveland Clinic Foundation, the MetroHealth System, and University Hospitals) and member of a national consortium of approximately 66 institutions funded by the National Institutes of Health to increase the efficiency and speed of clinical and translational research across the country.

The CCI’s mission is to enhance clinical and translational research efforts across the Cleveland area by: (1) spurring advances in knowledge of risk factors, outcomes and treatment effectiveness in the population; (2) facilitating the transfer of scientific advances to the community; and (3) developing a new generation of clinical researchers equipped with the skills needed to efficiently design, implement and interpret novel studies that address important public health questions. To accomplish its mission, the CCI provides computer systems and applications support for basic science and clinical research activities and works closely with basic science and clinical investigators in the CWRU Schools of Medicine, Nursing, and Dental Medicine, as well as the University Hospitals Case Medical Center, Cleveland Clinic, and MetroHealth System. The CCI has supported hundreds of clinical research and epidemiology projects, including local and national multicenter, longitudinal studies.  The CCI has two cores that provide research support to all investigators: the Academic Development Core and Statistical Sciences Core.

The Academic Development Core manages the newly created PhD Program in Clinical Translational Science, the Master’s Degree Program in Clinical Research (Clinical Research Scholars Program - see "Clinical Research" tab above), and the Graduate Certificate Program in Clinical Research. The Academic Development Core also delivers seminars and short courses in clinical research and works to coordinate educational activities in interdisciplinary clinical research across the CTSC’s institutional members. The programs target investigators and other key members of the research team, including data managers and study coordinators. Training efforts in research design, research data management, statistical sciences, statistical software, and scientific communication are emphasized.

Center for Global Health and Diseases

Phone: 216.368.6321
https://case.edu/medicine/globalhealth/node/1
James W. Kazura, MD, Director

The Center for Global Health and Diseases was formed in 2002 as a result of a merger between the Center for International Health (first established in 1987) and the Division of Geographic Medicine. The new center is located on the fourth floor of the Biomedical Research Building on the Case Western Reserve University’s School of Medicine campus in Cleveland, Ohio. The center provides a coordinating structure to help link the numerous international health resources of the university, its affiliated institutions, and the Northern Ohio community in a multidisciplinary program of research, training and clinical application related to global health. The center brings together many disciplines at CWRU to make life better in developing countries, and thus facilitates international collaborations throughout the institution.

The mission of the Center for Global Health and Diseases is to promote health in the world and enrich the community around CWRU.

This is accomplished by:

  • bringing together experts from the university’s community that specialize in infectious diseases, epidemiology, anthropology, tropical diseases, neglected tropical diseases (dengue, dracunculiasis [guinea-worm disease], lymphatic filariasis, onchocerciasis [river blindness], rabies, schistosomiasis, and various helminthiases), nursing, pediatrics, etc.
  • uniting university faculty in programs of collaborative research and education, student and faculty international exchanges, and community enrichment to promote health in the world and enrich the international community.

The center focuses on three main objectives that have been present throughout its history:

  • developing a critical mass of creative investigators with multidisciplinary capabilities and providing them with appropriate resources and environments for basic, clinical and epidemiological research, in order to develop linkages within and beyond the university community.
  • establishing an education and training program to ensure the continuing replenishment of the pool of intellectual talent in this country and to enhance the scientific proficiency of scientists from developing countries via an educational program based at the university, reaching a wide audience.
  • advancing a collaborative interdisciplinary application program in international health overseas to bring together diverse disciplines, adaptation, and adoption of practices and the application of technology to underserved populations of the world.

A certificate in Global Health is available.

Center for Medical Education

Phone: 216.368.1948
Patricia A. Thomas, MD, FACP, Director
Klara Papp, PhD, Director, CAML

The Center for Medical Education, established in 2010, provides an organizational home for teaching and learning programs in the School of Medicine and a supportive environment for those who want to develop special skills in medical education.

The Center also sponsors faculty appointments, both full- and part-time, for faculty whose roles are predominantly focused on teaching medical students and physician assistant students.  These include community clinicians who welcome medical students into their clinics and practices.
The Center for the Advancement of Medical Learning (“CAML”) operates its programs under the auspices of the CMEd. CAML supports and promotes the development of teaching and lifelong-learning skills among students, faculty, staff, residents, and alumni.  CAML pursues research into educational innovations to advance our knowledge of medical learning and teaching.  The Center offers workshops to faculty locally, regionally, and nationally to enhance faculty teaching, research and evaluation skills.

Center for Proteomics and Bioinformatics

Phone: 216.368.0291
http://proteomics.case.edu
Mark R. Chance, PhD, Director
Biomedical Research Building, Ninth Floor

The Case Center for Proteomics and Bioinformatics was created, in part, to strengthen Cleveland's presence in modern proteomics and bioinformatics research to make the region a leader in the field. The vision for the Center has been shaped over the past several years by the leadership of the Center's Director, Mark Chance, PhD, with over $120 million in grants awarded to the Center and its collaborators since its inception in February 2006. One of the primary goals of the CPB is to develop an infrastructure of sophisticated equipment that facilitates and maximizes shared equipment usage, as well as to offer a wide array of proteomics, and metabolomic services including protein and small molecule mass spectrometry, protein expression/interactions, systems biology, and biostatistical analyses.

The CPB has expanded its vision to include education of graduate students in systems biology and bioinformatics. The Center for Proteomics and Bioinformatics developed a graduate program in Systems Biology and Bioinformatics in collaboration with Schools and Departments across the campus. For more information regarding the SYBB graduate program please see "Systems/Bioinformatics" tab above.  You may also visit http://bioinformatics.case.edu/.

In studying proteins and metabolites, bioinformatics analysis enables researchers to take an integrated pan-omics approach for discovering networks involved in human disease. The School of Medicine has established the Center for Proteomics and Bioinformatics to perform research to better understand the genetic and environmental bases of disease as well as provide new technologies to diagnose diseases such as cancer, heart disease, and diabetes. Utilizing bioinformatics enables researchers to take an integrated -omics approach for discovering networks involved in human disease.

New technologies in mass spectrometry are also allowing protein expression, localization, structure, post-translational modifications, and interactions to be studied in increasing detail and on a genome-wide scale. The Center is also developing and applying state-of-the-art-structural proteomics technology, metabolomic and small molecule analysis, especially for pharmacokinetic (PK) studies to support clinical, translational, and structural research.

The CPB has three major research areas: Proteomics and Bioinformatics, Metabolomics, and Macromolecular Structure.

Proteomics and Bioinformatics faculty and staff support research in protein expression analysis, protein modifications, and protein interactions in a wide variety of biological contexts as well as develops new bioinformatics tools in Proteomics research. This includes multiple Proteomics Cores to support these activities.

Metabolomics faculty and staff support metabolite small molecule quantification research in the CWRU community.  The services provided range from drug PK studies to quantification of endogenous metabolites in clinical and preclinical samples.

Macromolecular Structure faculty and staff supports interdisciplinary research in new methods of structure determination, the combination of computational and experimental structural biology approaches and developing and maintaining the infrastructure for macromolecular structure determination.

The CPB also offers a wide range of seminars, workshops, and possibilities for individual training. These activities are posted on the CPB Web site. For a list of services and to explore opportunities to collaborate, please visit the Web site: https://case.edu/medicine/nutrition/case-center-proteomics-and-bioinformatics

Center for Psychoanalytic Child Development

Phone: 216.991.4472
Kimberly Bell, PhD; John A. Hadden Jr. Assistant Professor of Psychoanalytic Child Development

The Center for Psychoanalytic Child Development was established in 2001 as a memorial to John A. Hadden Jr., past President of the Board of Trustees of the Cleveland Center for Research in Child Development and of the Hanna Perkins School. The mission of the center is to advance the science of psychoanalytic child development at the School of Medicine.

The Center offers medical students and residents who are interested in working with children the opportunity for observational learning in the Hanna Perkins school. In addition, didactic courses, case conferences and supervision are available to deepen students’ understanding of the relationship between physical and psychological development in the first 5 years of life.

The Center for RNA Science and Therapeutics

Phone: 216.368.0299
https://www.rnacenter.org/
Jeffery M. Coller, PhD, Director

The Center for RNA Science and Therapeutics is a free standing academic unit in the basic sciences within the School of Medicine at Case Western Reserve University. The RNA Center was established in the mid-nineties as a core entity in recognition of the strong cadre of research laboratories devoted to studying post-transcriptional mechanisms of gene expression focusing on various aspects of RNA Biology.  The current mission of the RNA Center is to parlay the strengths of RNA Center scientists towards the development of unique therapeutic initiatives.  The RNA Center is combining the usage of nanoparticle technology with RNA science to develop new classes of drugs, leading towards the amelioration of a variety of diseases.  Current efforts are focused on metabolic disorders, cancer immunotherapies, immunity, and protein replacement. In addition, we are developing new technologies that promise to improve diagnostics, allowing for earlier detection of a variety of human diseases, especially cancer. 

The RNA Center contains one of the largest concentrations of RNA scientists in the nation.  The faculty of the RNA Center cover nearly every aspect of RNA research.  Current research in the Center focuses on several problems ranging from extremely basic questions such as the mechanism of RNA catalysis and how proteins interact with RNA to the roles of RNA processing in disease. Specific research interests include splicing and its regulation, RNA editing, tRNA maturation, mechanisms of translation regulation, RNA degradation, RNA trafficking, RNA interference and regulation of gene expression by microRNAs and non-coding RNAs.

Collectively, the RNA Center provides a valuable resource for collaborative efforts within the University and its affiliated institutions: the Cleveland Clinic Foundation, MetroHealth Medical Center, the Cleveland VA Medical Center, and University Hospitals Cleveland Medical Center.  In addition, the official journal of the RNA Society “RNA” was founded and continues to be housed in the RNA Center.  The members of the RNA Center have an excellent funding record and the research performed is regularly published in highly visible journals such as Science, Nature, Molecular Cell, NSMB, Molecular Cell, etc.  

Center for Science, Health and Society 

Phone: 216.368.2059
http://casemed.case.edu/cshs/
Nathan A. Berger, MD, Director

Recognizing that the successful futures of Case Western Reserve University, the City of Cleveland, and Cuyahoga County are integrally related, the Center for Science, Health and Society (CSHS) was created in 2002 to focus the efforts of the University and the community in a significant new collaboration to impact the areas of health and healthcare delivery systems through community outreach, education, and health policy. The Center, based in the School of Medicine, with university wide associations, is engaging the many strengths of the University and the community to improve the health of the community.

The Center has engaged the community at the level of the individual and the neighborhood, in public and private schools, at civic and faith-based organizations, and at the level of governmental agencies and community leadership to identify community problems, perceptions, assets and resources; advise the community of faculty skills, assets and expertise; and, catalyze that community service based scholarship that benefits community interests and promotes mutual enhancement. The Center coordinates the Scientific Enrichment Opportunity outreach program that brings Cleveland high school students on to the medical school campus in the summer to work along with our distinguished faculty in their research labs, to introduce and stimulate the students and help prepare them to enter careers in the health career professions and biomedical workforce. The Center also coordinates the Mini Medical School Program presented every Spring and Fall to educate the community on the latest developments in healthcare, particularly those developed at CWRU. The overall goal of these programs is to educate and empower the community to become better consumers of healthcare and more informed and stronger advocates for healthcare policy and legislation in their own interests.

Center for the Study of Kidney Biology and Disease

Phone: 216.444.8415
John R. Sedor, MD, Director
Thomas H. Hostetter, MD, Co-director
Jeffrey Garvin, MD, PhD, Co-director
Jeffrey Schelling, MD, Co-director

Chronic Kidney Disease (CKD) is a growing public health problem in the United States. More than seventeen percent of US adults—more than 30 million Americans—have CKD. CKD generally progresses over time and can cause cardiovascular disease, anemia, bone disease, fluid overload, and eventually end-stage kidney disease (ESKD). Patients with ESKD need renal replacement therapy, either from dialysis or a kidney transplant, to live. The risk of death for patients receiving dialysis is nearly eight times higher than the non-ESRD population, leading to a 20% annual probability of death. Kidney disease disproportionately affects minorities and vulnerable populations. Kidney disease treatment is expensive and uniquely tied to federal expenditures through the Medicare entitlement program. The cost of care for ~ 550,000 ESKD patients is nearly $34 billion annually, exceeding the total NIH budget. Treating all health conditions of CKD and ESRD patients consumes nearly 25% of Medicare’s budget.

The Center’s mission is to accelerate discovery and its translation for treatment and cure of kidney diseases in an interdisciplinary environment within the rich, research environment of the CWRU School of Medicine. The faculty is an accomplished and highly interactive group of investigators, based in the adult or pediatric Divisions of Nephrology in CWRU-affiliated hospitals as well as other clinical and basic science departments. Research interests of the faculty include digital pathology image analysis, glomerular diseases, diabetic and other chronic kidney diseases, epithelial cell biology and ion transport, tubular physiology, genetic epidemiology, health services research, renal transplantation, health disparities research and clinical trials. Center faculty are members of the NIDDK-funded Kidney Precision Medicine Project. Research projects use cellular, molecular biological, computational, genetic, genomic and epidemiological methods to study in vitro and animal models and/or patients. Many projects by Center investigators use health data, culled from electronic health records, and biological samples from patients with kidney diseases in order to generate novel hypotheses, which can then tested with animal models and cell lines. Training opportunities are available for undergraduate, pre- and post-doctoral students.

National Center for Regenerative Medicine

Phone: 216.368.0846
http://www.ncrm.us/
Stanton L. Gerson, MD, Director
The National Center for Regenerative Medicine (NCRM) is a platform to facilitate translational research, clinical application, and commercialization of regenerative medicine, tissue engineering, and stem cell therapeutics across a consortium of institutions. NCRM is driven by four nationally ranked, medical research powerhouses, Case Western Reserve University, Cleveland Clinic, University Hospitals Cleveland Medical Center and Ohio State University. Through this network of researchers and clinicians, research discoveries are actively being translated into cell-based therapies for patient care.

NCRM is leading the way in Northeast Ohio in the following areas:

  • Regenerative medicine and stem cell research
  • Cellular manufacturing
  • Clinical trials for cellular therapeutics

Global partnerships have been established with academic institutions and biotechnology companies to further expand research and discovery efforts.

NCRM Goals:

  • Translational Research: To support stem cell and regenerative medicine research across various disciplines, institutions and commercial entities.
  • Education and Training: To develop cutting-edge education programs for researchers, clinicians, trainees and the general public.  For more information regarding the RGME graduate program please visit https://case.edu/medicine/ncrm/training-education.
  • Strategic Partnership: To build networks across academic, clinical, commercial and public sectors.
  • Commercialization: To translate innovative technologies and cell-therapies into business opportunities.

Case Western Reserve University offers three areas of study in Clinical Research/Clinical Translational Science:

  1. Graduate Certificate in Clinical Research

  2. Master's in Clinical Research

  3. PhD in Clinical Translational Science

Each of the aforementioned programs was designed to fit an ever growing need for well-trained clinical investigators. The curriculum for each program was designed to make the student a more effective, ethical, and efficiient researcher.

The Graduate Certificate in Clinical Research

This 11 credit hour program provides the foundational training in clinical research methods to those individuals who are seeking an alternative to the Master of Science in Clinical Research. It is geared towards clinicians and other health-science professions who are interested in conducting clinical research and/or collaborating with other clinician-scientists who are conducting clinical research. This program is also beneficial to health-science students, basic-sicence researchers, and other health science professionals who would like to enhance their skills in patient-oriented research.

Clinical Research Scholars Program (CRSP)

The Clinical Research Scholars Program (CRSP) is designed for individuals committed to a career in clinical investigation in an academic or related field. CRSP offers a Master's Degree in Clinical Research through two pathways.

Training in both clinical research and career development provides CRSP Scholars with an educational experience that prepares them to identify a research question and critically evaluate relevant literature; transform the question into a feasible and valid study design; develop and execute the study protocol; and analyze and effectively communicate the findings.

The PhD in Clinical Translational Science Program

The goal of this program is to train and graduate clinical-translational scientists to meet the need for a transformed clinical and translational enterprise. Students in the program will be rigorously educated in the theory and practice of clinical translational science in order to make significant clinical discoveries and to move these discoveries across the translational continuum. The curriculum is based on a set of nationally-developed core competencies to guide the nationwide training of clinical and translational scientists and will provide students with the required knowledge, skills, and experience to become productive and innovative researchers in the field of Clinical Translational Science.

Faculty 

The program resides in the Department of Population and Quantitative Health Sciences (PQHS) in the School of Medicine. The academic units involved include the School of Medicine, Nursing, Management, and Dentistry. The faculty is selected for their expertise and commitment to teaching and mentorship in clinical investigation. They are primarily drawn from the Departments of Medicine, Pediatrics, and PQHS from the School of Medicine.

For Questions and Information Please Contact:

Angela Bowling, MA
Clinical Research Scholars Program
Case Western Reserve University
10900 Euclid Ave., W-G74A
Cleveland, OH 44106-4945

216.368.2601

Clinical Research Scholars Program (CRSP)

The Clinical Research Scholars Program (CRSP) is designed for individuals committed to a career in clinical investigation in an academic or related field.

CRSP offers a Master's Degree in Clinical Research through two pathways:

  1. CRSP Type A (Thesis) -
  • Curriculum was developed for those with an existing degree in medicine, dentistry, nursing, or an allied science such as pharmacy or biomedical engineering.
  • This pathway is to prepare a new generation of clinical investigators for leadership roles in academia, government, and industry.
  1. ​​CRSP Type B (Capstone) -
  • Curriculum was created for individuals who may not be playing a principal investigator or clinical research study, but who:
  • desire strong preparation in clinical research methods and associated statistical approaches
  • envision themselves playing a critical role on the clinical research team as a research assistant, study coordinator, or data manager
  • This pathway is to provide the student with fundamental knowledge and/or experience in important tasks related to the clinical research endeavor.

Training in both clinical research and career development provides CRSP Scholars with an educational experience that prepares them to identify a research question and critically evaluate relevant literature; transform the question into a feasible and valid study design; develop and execute the study protocol; and analyze and effectively communicate the findings.

The CRSP program consists of three parts:

  • Formal didactic modular and semester-long course work
  • A seminar series that focuses on communication skills required for career development
  • An intensive mentored experience centered on a specific clinical research problem (Type A Pathway) or a Capstone Project (Type B Pathway)

It is expected that individuals so trained can master fully the challenges in clinical investigation of the next decade, particularly the new translational opportunities being developed. As such, they should be attractive candidates for positions in clinical science departments, research institutes, or industry.

A dual degree track has also been established for medical students interested in obtaining dual MD/MS degree. The dual MD/MS program:

  • seeks individuals committed to a career in clinical investigation in an academic or related environment
  • consists of a total of 30 credits: 21 credit hours of coursework, 9 credit hours of mentored research and a formal oral thesis defense
  • both focus and flexibility in its curriculum -
    • Focus is provided through a core curriculum (15-16 credit hours) highlighting clinical research methods, the ethical conduct of research, and a seminar series that introduces the skills necessary for scholarly success.
    • Flexibility is provided through elective coursework. Students typically have special interests in a particular area of clinical research, both clinically and methodologically. This program facilitates pursuit of different methodological interests guided by seasoned CWRU research faculty and addressed partly with choice of appropriate electives (5-6 credit hours).

Requirements for the dual MD/MS degree differ to reflect integration with the medical school curriculum. Most graduates of this program are currently working in academic medical settings, with smaller numbers located in research positions in the private sector or private practice.

CURRICULUM FOR THE TYPE A (THESIS) MASTER'S DEGREE IN CLINICAL RESEARCH

30 credit hours are required (of which 15-16 are core coursework; 9 of thesis research; and 5-6 of elective coursework) for completion of this Master of Science in Clinical Research degree.

Core Courses and Thesis Requirement

CRSP 401Introduction to Clinical Research Summer Series3
PQHS 490Epidemiology: Introduction to Theory and Methods3
CRSP 412Communication in Clinical Research - Grant Writing1
CRSP 413Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media1
CRSP 431Statistical Methods I3
CRSP 432Statistical Methods II3
CRSP 603Research Ethics and Regulation1 - 2
CRSP 651Clinical Research Scholars Thesis9
Total Units24-25


CURRICULUM FOR THE TYPE B (CAPSTONE) MASTER'S DEGREE IN CLINICAL RESEARCH

30 credit hours are required (of which 11-12 are core coursework; 3 Capstone; and 15-16 are elective coursework) for completion of this Master of Science in Clinical Research degree.

Core Courses and Capstone

CRSP 401Introduction to Clinical Research Summer Series1 - 3
PQHS 490Epidemiology: Introduction to Theory and Methods3
CRSP 413Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media1
CRSP 431Statistical Methods I3
CRSP 603Research Ethics and Regulation1 - 2
Total Units9-12

Each scholar is encouraged to develop his/her own area of concentration based on personal interests and needs.  Typical areas of concentration include: Clinical Research Trials, Health Services Research and Outcomes, and Multidisciplinary/Translational Clinical Research.  Please consult with CRSP faculty and your Research Mentor on which electives will best suit your needs.

The choices of electives listed below are for illustrative purposes and include but are not limited to:

CRSP 406Introduction to R Programming2
CRSP 410Independent Study in Clinical Research1 - 3
CRSP 440Translational & Patient-Oriented Research Theory3
CRSP 450Seminar in Multidisciplinary Clinical & Translational Research0
CRSP 500Design and Analysis of Observational Studies3
CRSP 501Team Science - Working in Interdisciplinary Research Teams1
CRSP 502Leadership Skills for Clinical Research Teams2
CRSP 503Innovation and Entrepreneurship1
CRSP 504Managing Research Records - A System's Approach2 - 3
CRSP 505Investigating Social Determinants of Health2 - 3
CRSP 510Health Disparities3
PQHS 411Introduction to Health Behavior3
PQHS 450Clinical Trials and Intervention Studies3
PQHS 467Comparative and Cost Effectiveness Research1

MS Clinical Research Type A (Thesis), Plan of Study

Prep YearUnits
Summer
CRSP Program starts in the Summer Term of First Year
Year Total:  
 
First YearUnits
FallSpringSummer
Epidemiology: Introduction to Theory and Methods (PQHS 490)3    
Research Ethics and Regulation (CRSP 603)1 - 2    
Statistical Methods I (CRSP 431)3    
Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media (CRSP 413)1    
Communication in Clinical Research - Grant Writing (CRSP 412)  1  
Elective  3  
Statistical Methods II (CRSP 432)  3  
Introduction to Clinical Research Summer Series (CRSP 401)    3
Year Total: 8-9 7 3
 
Second YearUnits
FallSpringSummer
Clinical Research Scholars Thesis (CRSP 651)3    
Elective3    
Clinical Research Scholars Thesis (CRSP 651)  3  
Clinical Research Scholars Thesis (CRSP 651)    3
Year Total: 6 3 3
 
Total Units in Sequence:   30-31

MS Clinical Research Type B (Capstone Experience), Plan of Study

Prep YearUnits
Summer
CRSP Program starts in the Summer Term of First Year
Year Total:  
 
First YearUnits
FallSpringSummer
Epidemiology: Introduction to Theory and Methods (PQHS 490)3    
Research Ethics and Regulation (CRSP 603)1 - 2    
Statistical Methods I (CRSP 431)3    
Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media (CRSP 413)1    
Electives3    
Electives  9-12  
Introduction to Clinical Research Summer Series (CRSP 401)    3
Introduction to R Programming (CRSP 406)    2
Year Total: 11-12 9-12 5
 
Second YearUnits
Fall
Elective2-6
CRSP 560 Capstone Experience3
Year Total: 5-9
 
Total Units in Sequence: 30-38

MD/MS Biomedical Investigation-Clinical Research Track

For information about Program Admission and MD requirements, please see MD Dual Degrees section. The Clinical Research track includes formal instruction in methods common to all fields of clinical investigation along with mentored research.  In addition to medical school credits, students must complete the track-specific courses and electives listed below.

All students in this track must complete the CRSP Core Curriculum or equivalents:

IBIS 434Integrated Biological Sciences in Medicine (**or IBIS 401 and 402)6
CMED 401Intro to Clinical Research and Scientific Writing3
or CRSP 401 Introduction to Clinical Research Summer Series
PQHS 490Epidemiology: Introduction to Theory and Methods3
CMED 403Introduction to Clinical Epidemiology3
or CRSP 402 Study Design and Epidemiologic Methods
CMED 404Clinical Research Seminars (*)1
or CRSP 412 Communication in Clinical Research - Grant Writing
CMED 405Clinical Research Seminars (*)1
or CRSP 413 Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media
CMED 450Clinical Trials3
CMED 458Statistical Modeling with Applications in Clinical Research3
CMED 500Scientific Integrity in Biomedical Research0-1
or IBMS 500 On Being a Professional Scientist: The Responsible Conduct of Research
CMED 601Clinical Research Project18
IBIS 600Exam in Biomedical Investigation0

Program Advisors: Dr. Chris Moravec (College students) and Dr. William Merrick (University students).

PhD in Clinical Translational Science

The goal of the PhD in Clinical Translational Science program is to train and graduate clinical-translational scientists to meet the need for a transformed clinical and translational enterprise. Students in the program will be rigorously educated in the theory and practice of clinical translational science in order to make significant clinical discoveries and to move these discoveries across the translational continuum. 

The program's curriculum is based on a set of nationally-developed core competencies to guide the nationwide training of clinical and translational scientists and is purposefully designed to furnish our students with the required knowledge, skills and experience to become productive and innovative researchers in the field of clinical translational science.

Program graduates will be able to:

  • Independently lead, design, execute, manage and interpret multidisciplinary clinical-translational research in a conceptually, methodologically, ethically and regulatory sound manner
  • Assume leadership roles in both academic and industry settings
  • Establish national reputations as leaders in a given area of expertise.

Eligible applicants include: 

  • Individuals with an advanced clinical degree (e.g., MD, DMD, DRNP) 
  • Individuals enrolled in dual clinical-research degree programs, such as CWRU’s MD-PhD and DMD-PhD programs
  • Individuals with an existing Master’s degree in a health-related field  (e.g., MS, MSN, MPH)
  • Individuals with other scientific or clinical backgrounds to be evaluated on a case-by-case basis.

Curriculum Requirements:

Curriculum requirements are based on student's previous education and training:

  • Student with No Existing Advance Research Degree - 
    • Students will complete a minimum of 54 credit hours
    • 36 credit hours is coursework, of which a minimum of 24 must be graded. 
      • 19 credit hours will be required coursework
      • 17 credit hours are elective courswork
    • 18 credit hours of Dissertation

Students with an Advanced Research Degree (e.g. MS, MPH, MNS) -

Students with a relevant advanced degree must petition the PhD Steering Committee to obtain a waiver for required coursework. For the waiver, the student must submit transcripts showing the course and grade, as well as the syllabus for the course.

Per the School of Graduate Studies, curriculum for individual with relevant advanced degree:

  • Minimum of 18 credit hours of coursework, of which 12 must be graded. The courses used to achieve the 18 credit hours will depend on individual needs and require the academic advisor’s (mentor’s) approval.
  • 18 credit hour of Dissertation

Students Seeking Dual Degree MD/PhD Through Case Western Reserve University's Medical Scientist Training Program and Clinical Translational Science Training Program:

Curricula of the two-degree programs are integrated.

Curriculum for Dual-Degree students:

  • 39 credit hours of coursework, as follows:
    • 16 credit hours of required courses (CRSP 401, “Introduction to Clinical Research”, is waived as course material is covered in medical school’s curriculum)
    • 2 credit hours of core electives
    • 6 credit hours of research rotations
    • Up to 18 credit hours of CRSP 601, “Research Practicum”, or electives

The PhD in Clinical Translational Science Curriculum:

  • REQUIRED COURSES:
CRSP 401Introduction to Clinical Research Summer Series3
PQHS 490Epidemiology: Introduction to Theory and Methods3
CRSP 412Communication in Clinical Research - Grant Writing1
CRSP 413Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media1
CRSP 431Statistical Methods I3
CRSP 432Statistical Methods II3
CRSP 440Translational & Patient-Oriented Research Theory3
CRSP 450Seminar in Multidisciplinary Clinical & Translational Research0
CRSP 501Team Science - Working in Interdisciplinary Research Teams1
CRSP 550Meta-Analysis & Evidence Synthesis2 - 3
CRSP 603Research Ethics and Regulation1 - 2
Total Units21-23

CORE ELECTIVES

Student must take a minimum of 2 credit hours of courses from the list below, depending on their specific needs and mentor approval.

CRSP 502Leadership Skills for Clinical Research Teams2
SYBB 421Fundamentals of Clinical Information Systems3
PQHS 450Clinical Trials and Intervention Studies3
PQHS 467Comparative and Cost Effectiveness Research1
Total Units9

ELECTIVES:

Students will take electives and CRSP 601, "Research Practicum," to satisfy the graded and pass/fail course requirements and to advance to candidacy. These courses are selected based on students' needs and mentor approval. Any CWRU credit-bearing course may qualify. The courses could be "field specific" or include other core elective courses not taken as part of the requirement above. The following list is for illustative purposes only and is not limited to those listed.

PQHS 490Epidemiology: Introduction to Theory and Methods3
CRSP 410Independent Study in Clinical Research1 - 3
CRSP 500Design and Analysis of Observational Studies3
CRSP 504Managing Research Records - A System's Approach2 - 3
CRSP 505Investigating Social Determinants of Health2 - 3
CRSP 510Health Disparities3
NURS 518Qualitative Nursing Research3
PQHS 411Introduction to Health Behavior3
SASS 614Models of Qualitative Research3
Total Units23-27

RESEARCH COMPONENT

CRSP 601Research Practicum1 - 9
CRSP 701Dissertation Ph.D.1 - 9
Total Units2-18

=================================================

SAMPLE TRACK OF STUDENT WITH NO EXISTING ADVANCE RESEARCH DEGREE: 

Prep YearUnits
Summer
CRSP Program starts in the Summer Term of First Year
Introduction to Clinical Research Summer Series (CRSP 401)1 - 3
Year Total: 1-3
 
First YearUnits
FallSpringSummer
Statistical Methods I (CRSP 431)3    
Translational & Patient-Oriented Research Theory (CRSP 440)3    
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0    
Epidemiology: Introduction to Theory and Methods (PQHS 490)3    
Communication in Clinical Research - Grant Writing (CRSP 412)  1  
Elective  3  
Statistical Methods II (CRSP 432)  3  
Meta-Analysis & Evidence Synthesis (CRSP 550)  2 - 3  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0  
Research Practicum (CRSP 601)  1 - 9  
Introduction to Clinical Research Summer Series (CRSP 401)    3
Year Total: 9 10-19 3
 
Second YearUnits
FallSpringSummer
Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media (CRSP 413)1    
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0    
Team Science - Working in Interdisciplinary Research Teams (CRSP 501)1    
Research Practicum (CRSP 601)1 - 9    
Research Ethics and Regulation (CRSP 603)1 - 2    
Fundamentals of Clinical Information Systems (SYBB 421)3    
Research Practicum (CRSP 601)  1 - 9  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0  
Clinical Research Scholars Thesis (CRSP 651)    3
Year Total: 7-16 1-9 3
 
Third YearUnits
FallSpring
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0  
Dissertation Ph.D. (CRSP 701)1 - 9  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0
Dissertation Ph.D. (CRSP 701)  1 - 9
Year Total: 1-9 1-9
 
Fourth YearUnits
FallSpring
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0  
Dissertation Ph.D. (CRSP 701)1 - 9  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0
Dissertation Ph.D. (CRSP 701)  1 - 9
Year Total: 1-9 1-9
 
Total Units in Sequence:  38-98

=================================================

SAMPLE TRACK OF STUDENT WITH ADVANCE RESEARCH DEGREE:

Prep YearUnits
Summer
CRSP Program starts in the Summer Term of First Year
Year Total:  
 
First YearUnits
FallSpringSummer
Translational & Patient-Oriented Research Theory (CRSP 440)3    
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0    
Research Practicum (CRSP 601)1 - 9    
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0  
Meta-Analysis & Evidence Synthesis (CRSP 550)  2 - 3  
Research Practicum (CRSP 601)  1 - 9  
Introduction to Clinical Research Summer Series (CRSP 401)    3
Year Total: 4-12 3-12 3
 
Second YearUnits
FallSpringSummer
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0    
Dissertation Ph.D. (CRSP 701) (EXAMINATION AND ADVANCEMENT TO CANDIDACY)1 - 9    
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0  
Dissertation Ph.D. (CRSP 701)  1 - 9  
Research Rotation in Medical Scientist Training Program (MSTP 400)    0 - 9
Year Total: 1-9 1-9  
 
Third YearUnits
FallSpring
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0  
Dissertation Ph.D. (PQHS 701)1 - 9  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0
Dissertation Ph.D. (CRSP 701)  1 - 9
Year Total: 1-9 1-9
 
Total Units in Sequence:  14-72

=================================================

SAMPLE TRACK OF STUDENT SEEKING DUAL DEGREE MD/PHD

Prep YearUnits
Summer
CRSP Program starts in the Summer Term of First Year
Research Rotation in Medical Scientist Training Program (MSTP 400)0 - 9
Year Total:  
 
First YearUnits
FallSpringSummer
Integrated Biological Sciences I (IBIS 401)1 - 9    
Clinical Science II (IBIS 412)2    
Research Rotation in Medical Scientist Training Program (MSTP 400)0 - 9    
Elective  3  
Integrated Biological Sciences II (IBIS 402)  1 - 9  
Clinical Science II (IBIS 412)  2  
Research Rotation in Medical Scientist Training Program (MSTP 400)  0 - 9  
Introduction to Clinical Research Summer Series (CRSP 401)    3
Year Total: 3-20 6-23 3
 
Second YearUnits
FallSpring
Integrated Biological Sciences III (IBIS 403)1 - 9  
Clinical Science III (IBIS 413)2  
Translational & Patient-Oriented Research Theory (CRSP 440)3  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0
Meta-Analysis & Evidence Synthesis (CRSP 550)  2 - 3
Research Practicum (CRSP 601)  1 - 9
Year Total: 6-14 3-12
 
Third YearUnits
FallSpring
Statistical Methods I (CRSP 431)3  
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)0  
Team Science - Working in Interdisciplinary Research Teams (CRSP 501)1  
Research Ethics and Regulation (CRSP 603)1 - 2  
Epidemiology: Introduction to Theory and Methods (PQHS 490)3  
Communication in Clinical Research - Grant Writing (CRSP 412)  1
Statistical Methods II (CRSP 432)  3
Seminar in Multidisciplinary Clinical & Translational Research (CRSP 450)  0
Research Practicum (CRSP 601)  1 - 9
Year Total: 8-9 5-13
 
Total Units in Sequence:  34-103

Certificate in Global Health

Ronald Blanton, MD, Director            
216.368.4814

Daniel Tisch, PhD, Co-Director
216.368.0875                          

The Certificate is the centerpiece of the Framework for Global Health Curricula comprised of faculty from across the Case Western Reserve University campus, whose objective is to promote education in global health issues.  Nearly every department at CWRU offers multiple educational activities in global health.  Rather than attempt to own all of these activities, the group at CWRU (representing Applied Social Sciences, Anthropology, Bioethics, Biology, Engineering, Mathematics, Medicine, Nursing, Population and Quantitative Health Sciences) elected to develop a structure within which each department could develop independently while taking advantage of what the others had to offer.  The organizing structure for this became the certificate program rather than a separate degree.  This approach recognizes that student's need to graduate within a recognized discipline as well as recognition of a student’s focus, time and effort in training. 

Each student in the Certificate program will be grounded in global health by a core course (INTH 301 Fundamentals of Global Health/INTH 401 Fundamentals of Global Health) that will allow them to understand concepts and vocabulary across disciplines and that will facilitate meaningful communication with others based in a different discipline.  In addition to the Certificate, the Framework for Global Health Curricula had identified and is annotating all global health related courses at CWRU.  It has supported the recent revival of Medical Spanish and new courses and electives in Global Health. 

Requirements for Certificate in Global Health:

Anthropology

Undergraduate:

INTH 301Fundamentals of Global Health3
ANTH 215Health, Culture, and Disease: An Introduction to Medical Anthropology3
ANTH 359Introduction to Global Health3
And one elective selected from list of approved electives in the Anthropology Department

Contact: Vanessa M. Hildebrand, 216.368.2630

Graduate:          

INTH 401Fundamentals of Global Health3
ANTH 459Introduction to Global Health3
ANTH 511Seminar in Anthropology and Global Health: Topics3
And one elective selected from list of approved electives in the Anthropology Department

Contact: Janet McGrath, 216.368.2287


Bioethics         

INTH 401Fundamentals of Global Health3
BETH 414International Health Research Ethics3
And complete one elective selected from list of approved electives in the Bioethics Department

Contact: Patricia Marshall, 216.368-6196


Population and Quantitative Health Sciences        

INTH 401Fundamentals of Global Health3
PQHS 484Global Health Epidemiology1 - 3
And complete an epidemiology research project with global perspective (may be substituted with other course work).

Contact: Daniel Tisch, 216.368.0875


Math/Applied Math specialization: 

INTH 301Fundamentals of Global Health3
or INTH 401 Fundamentals of Global Health
PQHS 431Statistical Methods I3
or PQHS 490 Epidemiology: Introduction to Theory and Methods
MATH 449Dynamical Models for Biology and Medicine3
or EECS 397/600 Special Topics
Complete a heal related modeling project with global perspective (may be substituted with other course work).

 Contact: David Gurarie, 216.368.2857


Medicine

INTH 401Fundamentals of Global Health3
Complete a global health related project (may be student's thesis or may be substituted with other course work)

Contact: Ronald Blanton, 216.368.4814


Nursing

Undergraduate:

INTH 301Fundamentals of Global Health3
NURS 372Health in the Global Community3
NURS 394Global Health Seminar3
Complete a global health related project (may be substituted with other course work)

Graduate:       

INTH 401Fundamentals of Global Health3
NURS 394Global Health Seminar3
Complete a global health related project (may be substituted with course work)

 Contact: Elizabeth Madigan, 216.368.8532


Biology           

INTH 301Fundamentals of Global Health3
or INTH 401 Fundamentals of Global Health
Additional Biology electives from approved list

Contact: Christopher Cullis, 216.368.5362


Engineering

INTH 301Fundamentals of Global Health3
or INTH 401 Fundamentals of Global Health
Approved electives Engineering related courses

Contact: N. Sree Sreenath, 216.368.6219


Mandel School of Applied Social Sciences           

INTH 401Fundamentals of Global Health3
Additional MSASS elective from approved list

Contact: Sharon Milligan, 216.368.2335

Certificate in Cancer Biology

216.844.5375 
Stanton Gerson, MD, Director
Damian J. Junk, PhD, Assistant Director Cancer Training and Education, Case Comprehensive Cancer Center
http://www.case.edu/cancer/

The Clinical Oncology Research Career Development Program (CORP) provides interdisciplinary training in clinical and translational oncology research for clinical oncology junior faculty physicians who are interested in pursuing academic research careers as physician scientists. This training addresses the need for clinician investigators to translate fundamental cancer research discoveries into medical care of cancer patients. Eligible candidates are physicians (MD, DO or MD/PhD) with a clinical training background in one of a number of oncology disciplines, including medical, surgical, pediatric, dermatological, gynecological and radiation oncology. Scholars select one of three areas of concentration:

  • Mechanism Based Therapeutics and Clinical Trials

  • Stem Cell Biology and Hematopoietic Malignancy Clinical Trials

  • Prevention, Aging and Cancer Genetics and Clinical Trials

The Scholars' individual training plan consists of a 2-year certificate program which includes a didactic curriculum designed to provide basic background and highly individualized advanced training in both clinical and methodological components of clinical and translational cancer research.

Each Scholar is co-mentored by both a basic or behavioral scientist and a clinical investigator. A mentoring committee comprised of faculty in the Scholar's focus of oncology research provides additional guidance and support. During the period of mentored laboratory training, the Scholars develop original hypothesis-based experiments related to disease mechanisms at a molecular or cellular level. As the Scholars build on their laboratory conclusions to create and implement clinical trials, they are mentored by clinical investigators. Clinical trials are aimed at developing new methods for diagnosis and testing promising ideas for novel therapeutic interventions. These components come together with the Scholar's presentations at a national conference, publications in peer review journals and application for independent funding as a physician scientist. 

This two-year certificate program is administered through the Case Comprehensive Cancer Center. The overall goal of the K12 CORP certificate program is to foster interdisciplinary training in clinical and translational oncology therapeutic research for physicians. Upon completion of this 15-19 hour two year training, scholars will earn the K12 CORP Certificate.

The formal didactic program includes a course in responsible conduct IBMS 500 On Being a Professional Scientist: The Responsible Conduct of Research (0) or CRSP 603 Research Ethics and Regulation (2 hr); CNCR 501 Translational Cancer Research A (Translational Cancer Research Course (1 hr/semester); and one elective (1-3). Additional required activities include Clinical Protocol Tutorials, Intensive Mentored Research Project, Ongoing seminars, Meetings and Presentations; and applications for independent funding. 

Formal Didactic Curriculum Coursework *:

IBMS 500On Being a Professional Scientist: The Responsible Conduct of Research1-2
or CRSP 603 Research Ethics and Regulation
CNCR 501Translational Cancer Research A (All four modules required, one each semester of the program (501-1, 501-2, 501-3, 501-4))1

 *Additionally, choose one course from following core courses for credit towards certificate:

CRSP 401Introduction to Clinical Research Summer Series1 - 3
CRSP 402Study Design and Epidemiologic Methods3
CRSP 406Introduction to R Programming2
CRSP 413Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media1
CRSP 412Communication in Clinical Research - Grant Writing1
CRSP 500Design and Analysis of Observational Studies3
CRSP 501Team Science - Working in Interdisciplinary Research Teams1

Graduate Certificate in Clinical Research

James Spilsbury, PhD, Director
Angela Bowling, Education Administrator
Center for Clinical Investigation
http://case.edu/medicine/crsp/programs/certificate-program/
216.368.2601

The Clinical Research Certificate program is a four course, 11 credit hour program. Students who successfully complete the required coursework will receive a Certificate in Clinical Research. Coursework includes: Introduction to Clinical and Translational Research; Study Design and Epidemiologic Methods; Advanced Statistics: Linear Models; and a course on Research Ethics and Regulation. 

Admissions will be administered by the Clinical Research Scholars program in the Populations and Quantitative Health Science Department. Individuals who want to participate in the program will complete an online application form that includes a brief personal statement describing the reason(s) for seeking clinical research training and a recent CV or resume. Per CWRU School of Graduate Studies requirements, individuals who are not already graduate-degree-seeking students at CWRU must submit to the School of Graduate Studies a completed non-degree application form. Individuals who are not faculty, staff, or employees of CWRU must also submit a transcript or copy of their diploma, documenting completion of a baccalaureate degree. Once accepted into the Certificate program, participants will register for the courses through the Student Information System. The program will have rolling admissions, and students will be able to start taking courses in the summer or fall semester. The coursework for the Certificate will be listed on the official CWRU transcript. However, the Certificate in Clinical Research will be issued by the Clinical Research Scholars Program, not the University, and will not appear on the official CWRU transcript.

Performance Standards: A grade of B or higher in each graded course will be required for successful completion of the Certificate program. Enrollees will be responsible for keeping track of the courses they take.

Required Courses:

CRSP 401Introduction to Clinical Research Summer Series3
CRSP 402Study Design and Epidemiologic Methods3
NURS 630Advanced Statistics: Linear Models3
or CRSP 431 Statistical Methods I
CRSP 603Research Ethics and Regulation2

Exit Standards: Students who complete all required coursework will submit a checklist to the Clinical Research Scholars Program notifying the Education Administrator/Manager that all coursework has been completed. This administrator will verify with the registrar’s office that all requirements have been met and will then issue a certificate to the enrollee, documenting completion of the program.

Post-baccalaureate Readiness Instruction for BioMedical Education (PRIME) Certificate Program

216.368.5296 
https://case.edu/medicine/prime
Anthony Saar, MEd
Director, PRIME Program

prime@case.edu

PRIME is a post-baccalaureate certificate (non-degree) program for students who need additional preparation to have a competitive application for MD or DO programs. 

This program is designed for two types of students:

  • Career changers - students who have not yet completed all their pre-med requirements.
  • Academic enhancers - students who need to improve their undergraduate GPA and their foundation in key pre-med content.

Key features of this program include:

  • A highly flexible and individually tailored program of study providing each student the preparation that they need to be competitive applicants
  • A dedicated program director who has experience advising for medical school admissions and who meets regularly with students one-on-one
  • Problem-based Clinical Inquiry (IQ) coursework designed to give students exposure to medical terminology and clinical reasoning and develop professional growth via self-reflection
  • Specialized Medical College Admissions Test (MCAT) preparatory course designed to comprehensively review all MCAT content areas, as well as testing methods.
  • Diverse opportunities for shadowing, volunteering, and research in affiliation with 4 world-class health systems (The Cleveland Clinic, University Hospitals Cleveland Medical Center, VA Medical Center, and MetroHealth Medical Center)
  • Opportunity to interview with the CWRU School of Medicine for select students

The PRIME program is highly flexible. To earn the certificate, students must complete at least 24 credit hours. A program of study must be approved by the program director. Each student will work closely with the program director to tailor the program to their needs. Based on previous coursework taken, some students may need to take more than 24 credit hours to complete the prerequisite courses for medical school and earn the PRIME certificate. This program can be completed in 1-2 years, depending on a student's individual needs.

Required Program Coursework:
MGRD 310Introduction to Clinical Inquiry (IQ)3
MGRD 311Introduction to Clinical Inquiry (IQ) II3
Required Medical School Coursework:
BIOC 307Introduction to Biochemistry: From Molecules To Medical Science4
BIOL 214Genes, Evolution and Ecology3
BIOL 214LGenes, Evolution and Ecology Lab1
BIOL 215Cells and Proteins3
BIOL 215LCells and Proteins Laboratory1
or BIOL 216 Development and Physiology
BIOL 216LDevelopment and Physiology Lab1
CHEM 105Principles of Chemistry I3
CHEM 106Principles of Chemistry II3
CHEM 113Principles of Chemistry Laboratory2
CHEM 223Introductory Organic Chemistry I3
CHEM 224Introductory Organic Chemistry II3
CHEM 233Introductory Organic Chemistry Laboratory I2
CHEM 234Introductory Organic Chemistry Laboratory II2
MATH 125Math and Calculus Applications for Life, Managerial, and Social Sci I4
MATH 126Math and Calculus Applications for Life, Managerial, and Social Sci II4
or STAT 201 Basic Statistics for Social and Life Sciences
PHYS 115Introductory Physics I4
PHYS 116Introductory Physics II4
PSCL 101General Psychology I3
SOCI 101Introduction to Sociology3

Students may have completed some of these required courses prior to the start of this program and thus the students would be eligible for exemption from taking these courses for the certificate. Depending on course grades, students, with approval of the program director, may waive the required courses. Students may also elect to retake these courses for reference and/or to improve their undergraduate GPA.

Elective Coursework

In consultation with the program director, students will develop the best program of study for their needs. Typically, if a student has already taken the medical school prerequisites, but needs to improve their overall undergraduate GPA, taking upper level undergraduate courses would show more rigor compared to retaking lower level courses. With successful grades, a student’s undergraduate GPA will also improve.

Students may take additional elective coursework across the university with program director and instructor approval. Although science and math classes will be the primary focus for most students, some students may also seek to take graduate coursework to demonstrate academic rigor. Further, some students may also elect to take other courses based on interests or a desire to improve technical skills (such as writing or language skills).

Systems Biology and Bioinformatics MS and PhD Programs

BRB 9th Floor, School of Medicine
http://bioinformatics.case.edu/
Phone: 216.368.6971
David T. Lodowski, PhD, Co-Director
Mark Chance, PhD, Co-Director
Program email: sybb@case.edu


Do you want to convert big data into understandable models that just might change the world? With a graduate degree in systems biology and bioinformatics, you can combine your love of math, statistics, computers and biology to develop computational models with which to provide new insight and understanding of big data, leading to big discoveries in both laboratory or clinical settings.

Data science is the convergence of data engineering, math, statistics, advanced computing, the scientific method and subject-matter expertise. It involves the collection, management and transformation of "big data" into actionable information that can answer some of the world's most pressing problems. Yet there is a distinct need for data science experts who can efficiently interpret data into information that is useful for strategic decision-making. It is the goal of the Systems Biology and Bioinformatics program to produce the scientists that are needed to assist in extracting meaning from the burgeoning biological 'omics field. 

‌The SYBB program offers a multidisciplinary training program personally customized to the student leading to an MS or PhD. The program draws training faculty (currently 38 trainers) from more than 12 departments and 6 schools across the CWRU campus, ensuring students in the program acquire the core competencies needed to succeed in the bioinformatic analysis of biological big data.

The Systems Biology and Bioinformatics PhD program at CWRU offers trainees the opportunity to combine both experimental and computational or mathematical disciplines to understand complex biological systems. The SYBB program will train scientists who are able to generate and analyze experimental data for biomedical research and to develop physical or computational models of the molecular components that drive the behavior of a biological system. The goal of the program is to produce scientists who are familiar with multiple disciplines and equipped to conduct interdisciplinary research.

The Case Western Reserve University (CWRU) graduate program in Systems Biology and Bioinformatics (SYBB) has two tracks:

Translational Bioinformatics - The SYBB track in Translational Bioinformatics poises students to work at the interface of applied ‘omics research and clinical medicine. From integrating genomic and functional genomic data into electronic medical records, to developing meta-analysis tools for communicating genomic risk to patients to utilizing this data in personalized medicine. Students trained in the Translational Bioinformatics track work to integrate bioinformatics tools and technologies into clinical workflows. Graduates of this training track will find ample opportunities within industry and, as genomics enters the clinical arena, within hospitals, as well.

Molecular and Computational Biology - The SYBB track in Molecular and Computational Biology embraces the pursuit of basic science research, employing the application and development of computational approaches to address difficult questions derived from today’s “Big data” derived from ‘omics approaches. This track equips students in the acquisition of experimental data utilizing approaches including proteomics, metabolomics, genomics and structural biology and extends this work with interpretation provided by computational analysis. Graduates of this training track will find ample opportunities within the pharmaceutical industry, contract research organizations as well as more traditional academic career paths.

Students can choose either track for both the MS and PhD programs.

The SYBB participating departments and centers include:

  • Biology
  • Biomedical Engineering
  • Case Comprehensive Cancer Center
  • Cleveland Clinic Lerner College of Medicine
  • Center for Proteomics and Bioinformatics
  • Center for Systems Immunology
  • Electrical Engineering and Computer Science
  • Epidemiology and Biostatistics
  • Genetics and Genome Sciences
  • Mathematics
  • Nutrition
  • Physiology and Biophysics
  • Pharmacology
Program Competencies

The specific academic requirements of the SYBB Program are intended to provide students with a required core curriculum in Systems Biology and a set of electives designed both to assure minimum competencies in Fundamental Core Competencies and equip them for their particular thesis research discipline. Each trainee will be guided in their customized course of study by a mentoring committee to ensure the completion of training in the program competencies as well as maintenance of a focus on molecular systems theory. These competencies include:

  • Evaluation of the scientific discovery process and of the role of bioinformatics in it in detail, including data generation steps and understanding the biology.
  • Application of computational and statistical methods appropriate to solve a given scientific problem
  • Construction of software systems of varying complexity based on design and development principles.
  • Effective teamwork to accomplish a common scientific goal.
  • Building knowledge in local and global impact of bioinformatics and systems biology on individuals, organizations, and society.
  • Effective communication of bioinformatics and systems biology problems to a range of audiences, including, but not limited to, other bioinformatics professionals.
Masters Degree Plan A Summary

The minimum requirements for the master’s degree under Plan A are 21 semester hours of course work plus a thesis equivalent to at least 9 semester hours of registration for 30 hours total. These must include SYBB 501 Biomedical Informatics and Systems Biology Journal Club, and a minimum of 9 hours of SYBB 651 Thesis MS. Additional required courses for the Translational Bioinformatics and Molecular and Computational Biology tracks are SYBB 459 Bioinformatics for Systems Biology and SYBB 555 Current Proteomics.  The curriculum plan must be approved by the program steering committee and include appropriate coverage of the core competencies in genes and proteins, bioinformatics, and quantitative modeling and analysis. At least 18 semester hours of course work, in addition to thesis hours, must be at the 400-level or higher.

Each student must prepare an individual thesis that must conform to regulations concerning format, quality, and time of submission as established by the dean of graduate studies as well as conforming to the SYBB program guidelines. For completion of master’s degrees under Plan A, an oral examination (defense) of the master’s thesis is required, where the examination is conducted by a committee of at least three members of the university faculty.

Masters Degree Plan B Summary

The minimum requirements for the master’s degree under Plan B are 30 semester hours of course work (with at least 18 semester hours of course work at the 400 level or higher) and a written comprehensive examination or major project with report to be administered and evaluated by the program steering committee. The coursework must include SYBB 501 Biomedical Informatics and Systems Biology Journal Club. Additional required courses for the Translational Bioinformatics and Molecular and Computational Biology tracks are SYBB 459 Bioinformatics for Systems Biology and SYBB 555 Current Proteomics.   The curriculum plan must be approved by the program steering committee and include appropriate coverage of the core competencies in genes and proteins, bioinformatics, and quantitative modeling and analysis.

Sample Plan of Study for MS Degree in Molecular and Computational Biology

Plan of Study includes required courses as well as electives. 

First YearUnits
FallSpring
Survey of Bioinformatics: Technologies in Bioinformatics (SYBB 411A)1  
Survey of Bioinformatics: Data Integration in Bioinformatics (SYBB 411B)1  
Survey of Bioinformatics: Translational Bioinformatics (SYBB 411C)1  
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)0  
Statistical Methods I (PQHS 431)3  
Topical Elective from Elective Course List3  
Survey of Bioinformatics: Programming for Bioinformatics (SYBB 412)  3
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)  0
Current Proteomics and Bioinformatics (SYBB 555)  3
Additional 3 Credit Course TBD  3
Year Total: 9 9
 
Second YearUnits
FallSpring
Machine Learning (EECS 440)3  
Protein Biophysics (BIOC 475)3  
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)0  
Thesis M.S. (SYBB 651)3  
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)  0
Thesis M.S. (SYBB 651)  3 or 6
Year Total: 9 3-6
 
Total Units in Sequence:  30-33

PhD Program Summary

The Systems Biology and Bioinformatics program differs from current CWRU programs in the comprehensive requirement for an understanding of biological systems, bioinformatics, and quantitative analysis & modeling. The program includes a minimal set of required courses including (SYBB 501 Biomedical Informatics and Systems Biology Journal Club) and a course in the Responsible Conduct of research (IBMS 500 On Being a Professional Scientist: The Responsible Conduct of Research). Additional required courses for the Translational Bioinformatics and Molecular and Computational Biology tracks are SYBB 459 Bioinformatics for Systems Biology and SYBB 555 Current Proteomics.  At least six additional courses will be required based upon individualized student interests. Other requirements include a qualifier exam, a PhD Dissertation, and oral defense. The total credits required for the PhD is at least 54 credits: 24 graded credits, 12 pre-dissertation research credits, and at least 18 dissertation research credits.  Admissions to this program may be obtained through the integrated Biomedical Sciences Training Program, by direct admission to the department in rare cases or via the Medical Scientist Training Program.

Sample Plan of Study for PhD Degree

Plan of study includes required courses as well as electives.  Visit http://bioinformatics.case.edu/ for information regarding Plan of Study for all SYBB Tracks.

Plan of Study Grid for Translational Bioinformatics Track

First YearUnits
FallSpring
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)0  
Survey of Bioinformatics: Technologies in Bioinformatics (SYBB 411A)1  
Survey of Bioinformatics: Data Integration in Bioinformatics (SYBB 411B)1  
Survey of Bioinformatics: Translational Bioinformatics (SYBB 411C)1  
Cell Biology I (IBMS 453)3  
Molecular Biology I (IBMS 455)3  
Systems Biology and Bioinformatics Research (SYBB 601)1-9  
Survey of Bioinformatics: Programming for Bioinformatics (SYBB 412)  3
Current Proteomics and Bioinformatics (SYBB 555)  3
Bioinformatics for Systems Biology (SYBB 459)  3
Systems Biology and Bioinformatics Research (SYBB 601/651)  1-9
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)  0
On Being a Professional Scientist: The Responsible Conduct of Research (IBMS 500)  1
Year Total: 10-18 11-19
 
Second YearUnits
FallSpring
Contemporary Approaches to Drug Discovery (SYBB 528)3  
Fundamentals of Clinical Information Systems (SYBB 421)3  
Statistical Methods I (PQHS 431)3  
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)0  
BioDesign (SYBB 472)  3
Biomedical Informatics and Systems Biology Journal Club (SYBB 501)  0
Systems Biology and Bioinformatics Research (SYBB 601)  3
Statistical Methods II (PQHS 432)  3
Year Total: 9 9
 
Third YearUnits
FallSpring
Dissertation Ph.D. (SYBB 701)1-9  
Dissertation Ph.D. (SYBB 701)  1-9
Year Total: 1-9 1-9
 
Fourth YearUnits
FallSpring
Dissertation Ph.D. (SYBB 701)1-9  
Dissertation Ph.D. (SYBB 701)  1-9
Year Total: 1-9 1-9
 
Fifth YearUnits
FallSpring
Dissertation Ph.D. (SYBB 701)1-9  
Dissertation Ph.D. (SYBB 701)  1-9
Year Total: 1-9 1-9
 
Total Units in Sequence:  45-109

Footnotes

Required Core Courses for the Molecular and Computational Biology and Translational Bioinformatics Tracks of the MS and PhD programs

Course List

SYBB 459Bioinformatics for Systems Biology3
SYBB 555Current Proteomics and Bioinformatics3
SYBB 501Biomedical Informatics and Systems Biology Journal Club0
SYBB 601Systems Biology and Bioinformatics Researchup to 9
SYBB 651Thesis M.S. (For MS Students only) *9 credits for Plan A, 0 credits for Plan B*
SYBB 701Dissertation Ph.D. (For PhD students only)18

Elective Courses for MS and PhD programs

Genes and Proteins Courses  

Course List

PHOL/CHEM/PHRM/BIOC/NEUR 475Protein Biophysics3
PHOL 456Conversations on Protein Structure and Function2
PHOL 480Physiology of Organ Systems4
IBMS 453Cell Biology I3
IBMS 455Molecular Biology I3
BIOC 452Nutritional Biochemistry and Metabolism3
BIOC 412Proteins and Enzymes3
BIOC 420Current Topics in Cancer3
BIOC 454Biochemistry and Biology of RNA3
SYBB 528Contemporary Approaches to Drug Discovery3
BETH 412Ethical Issues in Genetics/Genomics3

Bioinformatics and Computational Biology Courses 

Course List

BIOL/EECS 419Applied Probability and Stochastic Processes for Biology3
PQHS 451A Data-Driven Introduction to Genomics and Human Health3
EECS 458Introduction to Bioinformatics3
NEUR 478/BIOL 378/COGS/MATH 378/BIOL 478/EBME 478Computational Neuroscience3
SYBB 411ASurvey of Bioinformatics: Technologies in Bioinformatics1
SYBB 411BSurvey of Bioinformatics: Data Integration in Bioinformatics1
SYBB 411CSurvey of Bioinformatics: Translational Bioinformatics1
SYBB 412Survey of Bioinformatics: Programming for Bioinformatics3
SYBB 459Bioinformatics for Systems Biology3
SYBB 472BioDesign3

Quantitative Analysis and Modeling 

Course List

MPHP 405Statistical Methods in Public Health3
PQHS 431Statistical Methods I3
PQHS 432Statistical Methods II3
EECS 435Data Mining3
PQHS 515Secondary Analysis of Large Health Care Data Bases3
PQHS 480Introduction to Mathematical Statistics3
EECS 440Machine Learning3
MATH 441Mathematical Modeling3
EBME 300/MATH 449Dynamics of Biological Systems: A Quantitative Introduction to Biology3
MIDS 301Introduction to Information: A Systems and Design Approach3
PQHS 457Current Issues in Genetic Epidemiology: Design and Analysis of Sequencing Studies3
PQHS 451A Data-Driven Introduction to Genomics and Human Health3
PQHS 452Statistical Methods for Genetic Epidemiology3
PQHS 453Categorical Data Analysis3
PQHS 459Longitudinal Data Analysis3

Part-time SYBB MS program

The program in systems biology and bioinformatics offers a flexible curriculum with a minimal number of required classes (SYBB 501 Biomedical Informatics and Systems Biology Journal Club), SYBB 459 Bioinformatics for Systems BiologySYBB 555 Current Proteomics and Bioinformatics are the only required classes); the majority of classes taken toward the MS are tailored to the student's research interests and thesis project. This flexibility enables students that are interested in pursuing the MS on a part time basis to maximize employee tuition benefits. A CWRU employee (or spouse) has a total of 15 credit hours/year (6 per semester and 3 per summer session) with which to pursue a degree. Taking only this number will net a part time student a MS in 5 semesters and 2 summer sessions; not taking a class during the summer sessions will result in taking 6 semesters to get the MS; and if a student were to take a single class a semester, it would take 11 semesters to reach the requisite number of classes needed for the MS.

Master's of Science in Regenerative Medicine & Entrepreneurship (RGME)

Stanton L. Gerson, MD
Associate Professor, Pediatrics
Director, Case Comprehensive Cancer Center
Director, National Center for Regenerative Medicine
Professor, Medicine-Hematology/Oncology
slg5@case.edu

Tracey Bonfield, PhD
Associate Professor, Pediatrics
tracey.bonfield@case.edu

Horst von Recum, PhD
Associate Professor, Biomedical Engineering
horst.vonrecum@case.edu

https://case.edu/medicine/ncrm/training-education/masters-program-rgme

The RGME is the first two-year master's level program in Ohio focused on Regenerative Medicine and Entrepreneurship. Students enrolled in the RGME program will have access to cutting-edge clinical and research facilities along with small biotechnology companies within the network of the National Center for Regenerative Medicine (NCRM).

This unique, interdisciplinary program will provide a rigorous educational pathway targeting individuals seeking the advanced skills and training required to excel in the unique workforce necessary to support the exponential growth and application of the field of regenerative medicine. The Master’s program in RGME will train individuals to work in academic, commercial, and clinical settings to support cellular manufacturing, biotechnology innovation, legal and compliance, financial analyst and venture capital, and business development activities taking advantage of our strengths across the disciplines of regenerative medicine as a whole.

Core Courses

18 required core credits across disciplines

RGME 525Current Topics in Regenerative Medicine2
RGME 535Foundations in Regenerative Medicine3
RGME 545Stem Product Biology, Bench to Bedside Development and Therapeutic Translation3
RGME 560Regenerative Medicine Independent Study, Research Project3
RGME 565Regenerative Medicine Independent Study, Internship3
BIOL 491Contemporary Biology and Biotechnology for Innovation I3
BIOL 492Contemporary Biology and Biotechnology for Innovation II3

Electives

6 credits of science electives

6 credits of business electives (strongly recommended to be GENE 467, LAWS 5366, or PHYS 491)

Total Credit Hours Required for Degree:  30

Sample Curriculum

Fall Semester 1

RGME 535

BIOL 491

Science Elective

Seminars

Spring Semester 1

RGME 545

BIOL 492

Science Elective

Fall Semester 2

RGME 560

Business Development Elective (Strongly Recommended -GENE 467: Commercialization and IP Management)

Seminars

Spring Semester 2

RGME 565

Business Development Elective (Recommended - LAWS 5366: Venture Finance and Transactions; PHYS 491: Modern Physics for Innovation)

Questions? Contact Melanie Prestage (mxp449@case.edu) for more information. 

CRSP Courses

CRSP 401. Introduction to Clinical Research Summer Series. 1 - 3 Units.

This course is designed to familiarize one with the language and concepts of clinical investigation and statistical computing, as well as provide opportunities for problem-solving, and practical application of the information derived from the lectures. The material is organized along the internal logic of the research process, beginning with mechanisms of choosing a research question and moving into the information needed to design the protocol, implement it, analyze the findings, and draw and disseminate the conclusion(s). Prereq: M.D., R.N., Ph.D., D.D.S., health professionals.

CRSP 402. Study Design and Epidemiologic Methods. 3 Units.

This course will cover the methods used in the conduct of epidemiologic and health services research and considers how epidemiologic studies may be designed to maximize etiologic inferences. Topics include: measures of disease frequency, measures of effect, cross-sectional studies, case-control studies, cohort studies, randomized controlled trials, confounding, bias, effect modification, and select topics. Recommended preparation: CRSP 401 or permission of instructor.

CRSP 406. Introduction to R Programming. 2 Units.

This course will provide students with an introduction to R. Major topics will include session management, data objects, reading and writing data, restructuring and combining data frames, handling missing data, working with dates, statistical analysis concepts, and R traditional graphics. Students will learn R programming conventions, how to create, manage and edit R scripts programs, and how to interpret output. Each class will consist of a demo on each lesson followed by a practice session when time permits. Small research datasets will be used both in class examples and in the exercises for each lesson. Students will be expected to complete all homework assignments on time and submit a take-home final exam.

CRSP 407. Logistic Regression and Survival Analysis. 3 Units.

This course will focus on the conceptual understanding and practical application of multivariable modeling in the context of binary and time to event outcomes. Particular emphasis will be placed on model specification, assessment of model assumptions and proper interpretation and visualization of model results. Classes will generally involve a conceptual discussion of the topic in question, followed by a practical application using R statistical software. Planned topics include contingency tables, logistic regression models, Kaplan-Meier curves, Cox proportional hazard models, and sample size estimation for binary and time to event outcomes. Students will be expected to complete biweekly assignments and two course projects involving problem specification, data collection, analysis using R, and a presentation. Prior to taking this course students should have working knowledge of linear regression and its application using R. Students must have the latest software version of R installed on their laptops. Recommended preparation: CRSP 406. Prereq: NURS 630.

CRSP 410. Independent Study in Clinical Research. 1 - 3 Units.

Independent Study in Clinical Research enables the student to undertake study of advanced topics in clinical research that are not offered as standing courses at Case Western Reserve University. The student(s) and a member of the Clinical Research Scholars Program faculty, or another faculty member at CWRU, submit a 1-2 page proposal for independent study to the CRSP Program Director. The proposal should include a descriptive title (e.g., research method or clinical topic area) to be studied; a list of up to 5 student-centered objectives of the study; how the subject matter will be learned; and how success in achieving the objectives will be measured (e.g., manuscript, essay, grant proposal, or other written product; examination, etc.). It is expected that there will be at least one contact hour per week for each credit hour requested.

CRSP 412. Communication in Clinical Research - Grant Writing. 1 Unit.

Written communication is a critical skill in clinical science. We disseminate our work to others through publications, and we obtain the resources to conduct research through grant proposals. This course has been developed for Kl2 and CRSP scholars. The course focuses on writing grant proposals and, in particular, specific sections of an NIH-style grant. However, the principles discussed in the course apply to any type of proposal. Prereq: CRSP 401 or equivalent.

CRSP 413. Communication in Clinical Research - Oral Presentation, Posters, and the Mass Media. 1 Unit.

To move their work forward, investigators must be able to present their research effectively to both scientific and lay audiences. Although "the written word" is probably the first medium that comes to mind when we think of communication in scientific circles, other modes of communication are also vital. The main objective of this course is to help scholars improve their oral and poster presentation skills, as well as interaction with the mass media. This objective will be achieved through a combination of didactic sessions, readings, and presentations by the students. Prereq: CRSP 401 or equivalent.

CRSP 431. Statistical Methods I. 3 Units.

Application of statistical techniques with particular emphasis on problems in the biomedical sciences. Basic probability theory, random variables, and distribution functions. Point and interval estimation, regression, and correlation. Problems whose solution involves using packaged statistical programs. First part of year-long sequence. Offered as ANAT 431, BIOL 431, CRSP 431, PQHS 431 and MPHP 431.

CRSP 432. Statistical Methods II. 3 Units.

Methods of analysis of variance, regression and analysis of quantitative data. Emphasis on computer solution of problems drawn from the biomedical sciences. Design of experiments, power of tests, and adequacy of models. Offered as BIOL 432, PQHS 432, CRSP 432 and MPHP 432. Prereq: PQHS/EPBI 431 or equivalent.

CRSP 440. Translational & Patient-Oriented Research Theory. 3 Units.

Clinical (patient-oriented) and translational science has emerged as a new scientific discipline aimed to accelerate scientific discovery into effective practice. This course provides an overview of the theoretical framework, rationale, process, methodologies, and ethics of clinical and translational research. An integral feature of this course is the participation of a multidisciplinary teaching team, whose expertise and perspective will contribute to providing real-world insights into the complexities of translational and patient-oriented research.

CRSP 450. Seminar in Multidisciplinary Clinical & Translational Research. 0 Unit.

The purpose of this monthly seminar is to introduce students to the processes and challenges of multidisciplinary clinical/translational science, through which discoveries in the laboratory or in early clinical studies are transformed into interventions, treatments, and ultimately, best practices and policies on national and international levels. The seminar will use a case-based approach. Examination of active projects at Case Western Reserve University, Cleveland Clinic Foundation, the MetroHealth Medical Center, University Hospitals Case Medical Center, and the Louis Stokes Veterans Administration Medical Center will enable students to learn first-hand about clinical translational science in action.

CRSP 500. Design and Analysis of Observational Studies. 3 Units.

An observational study investigates treatments, policies or exposures and the effects that they cause, but it differs from an experiment because the investigator cannot control assignment. We introduce appropriate design, data collection and analysis methods for such studies, to help students design and interpret their own studies, and those of others in their field. Technical formalities are minimized, and the presentations will focus on the practical application of the ideas. A course project involves the completion of an observational study, and substantial use of the R statistical software. Topics include randomized experiments and how they differ from observational studies, planning and design for observational studies, adjustments for overt bias, sensitivity analysis, methods for detecting hidden bias, and focus on propensity score methods for selection bias adjustment, including multivariate matching, stratification, weighting and regression adjustments. Recommended preparation: a working knowledge of multiple regression, some familiarity with logistic regression, with some exposure to fitting regression models in R. Offered as CRSP 500 and PQHS 500.

CRSP 501. Team Science - Working in Interdisciplinary Research Teams. 1 Unit.

This course will assist learners to understand how different professional disciplines, each representing a body of scientific knowledge, can best work together to develop and disseminate translational knowledge. Learners will develop a set of skills specific to be an effective member and leader of an interdisciplinary research team, including working with different value and knowledge sets across disciplines, understanding the mental models of other disciplines, creating shared mental models, running effective meetings, managing conflict, giving and receiving feedback, and group decision making techniques. Using the small group seminar approach and case studies, learners will practice individual and group communication, reflective and self-assessment techniques, and engage in experiential learning activities regarding effective teamwork in interdisciplinary research teams. Techniques to increase group creativity and frame new insights will be discussed.

CRSP 502. Leadership Skills for Clinical Research Teams. 2 Units.

Leadership Assessment and Development is for participants to learn a method for assessing their knowledge, abilities, and values relevant to management; and for developing and implementing plans for acquiring new management related knowledge and abilities. The major goals of this course include generating data through a variety of assessment methods designed to reveal your interests, abilities, values, and knowledge related to leadership effectiveness; learning how to interpret this assessment data and use it to design/plan developmental activities; small group sharing of insights from the various assessments. Recommended preparation: K grant appointment or consent of instructor.

CRSP 503. Innovation and Entrepreneurship. 1 Unit.

The purpose of this module is to acquaint and ultimately engage clinical researchers with the business of innovation and entrepreneurship. Goals include: (1) to provide researchers with many of the skills that they would need to translate academic research into commercial uses: (2) to sensitize clinical researchers to the goals of the business community and facilitate their ability to work with the private sector on technology development; and (3) to make clinical researchers aware of the processes of academic technology development and transfer. Sessions consist of a lecture and case discussion facilitated by one of the co-directors.

CRSP 504. Managing Research Records - A System's Approach. 2 - 3 Units.

This course will provide an approach to managing data for research studies. Major topics include a discussion of a research study system including database design and development, data management, and clinical data management; how to evaluate the data needs of a study including the impact of required regulations; summary of key regulations; the role of the data manager including protocol review, development of a data management plan, CRF design, data cleaning, locking studies and ensuring best practices. Each session will include a lecture, class discussion, and student presentation.

CRSP 505. Investigating Social Determinants of Health. 2 - 3 Units.

The biopsychosocial model highlights the inter-related roles that biological, psychological, and social factors play in health and illness. This course is geared towards clinical research scholars who would like to incorporate aspects of the "social context" in their research. The course will examine the conceptualization, measurement, and effects of several key socio-cultural determinants of health and illness. Sample studies that incorporate social determinants of health will be reviewed. The course will also consider strategies and techniques to conduct clinical research involving social factors in socially and ethnically diverse settings. Students will be encouraged to develop a prototypical study design to incorporate social determinants in their research. To earn an optional third credit hour for this course, students will be required to complete additional assignments tailored to the students' research needs and interests upon mutual agreement with the instructor at the beginning of the course. Recommended preparation: CRSP 401.

CRSP 510. Health Disparities. 3 Units.

This course aims to provide theoretical and application tools for students from many disciplinary backgrounds to conduct research and develop interventions to reduce health disparities. The course will be situated contextually within the historical record of the United States, reviewing social, political, economic, cultural, legal, and ethical theories related to disparities in general, with a central focus on health disparities. Several frameworks regarding health disparities will be used for investigating and discussing the empirical evidence on disparities among other subgroups (e.g., the poor, women, uninsured, disabled, and non-English speaking populations) will also be included and discussed. Students will be expected to develop a research proposal (observational, clinical, and/or intervention) rooted in their disciplinary background that will incorporate materials from the various perspectives presented throughout the course, with the objective of developing and reinforcing a more comprehensive approach to current practices within their fields. Offered as CRSP 510, PQHS 510, MPHP 510, NURS 510, and SASS 510.

CRSP 550. Meta-Analysis & Evidence Synthesis. 2 - 3 Units.

Systematic reviews use reproducible methods to systematically search the literature and synthesize the results of a specific topic area. Meta-analysis is a specific analytic technique used to pool results of individual studies. Systematic reviews are useful ways to establish one's knowledge in a particular field of study, and can highlight gaps in research which can be pursued in future work. They can also inform the background of a grant. This course is designed to introduce students to the methods of conducting a high quality systematic review and meta-analysis of intervention studies. We will cover the design, methods, and analytic techniques involved in systematic reviews. These concepts will prepare students to conduct their own systematic review or evaluate the systematic reviews of others. Sessions will be lectures, labs, and presentations. Topics include developing a search strategy, abstracting key data, synthesizing the results qualitatively, meta-analytic techniques, grading the quality of studies, grading the strength of the evidence, and manuscript preparation specific to systematic reviews and meta-analysis of intervention studies. Caveat: If you would like to conduct a systematic review of your own that can be published after the course ends, you will need to have several other class members or colleagues willing to work with you on the project. The systematic review should be on a topic where you expect no more than 20-30 included studies in order to be able to complete the review soon after the course ends. Offered as CRSP 550 and PQHS 550. Prereq: CRSP 401, PQHS/EPBI 431, MPHP 405, NURS 532 or Requisites Not Met permission.

CRSP 560. Special Topics in Clinical Research. 1 Unit.

In this 1 credit hour course, students will explore particular issues and themes related to Clinical Research. The course content will vary and is designed to explore content not covered in other CRSP courses or to expand student knowledge on topics introduced by other CRSP courses.

CRSP 601. Research Practicum. 1 - 9 Units.

Research practicum and/or laboratory rotation.

CRSP 603. Research Ethics and Regulation. 1 - 2 Units.

This course is designed to introduce students to the ethical, policy, and legal issues raised by research involving human subjects. It is intended for law students, post-doctoral trainees in health-related disciplines and other students in relevant fields. Topics include (among others): regulation and monitoring of research; research in third-world nations; research with special populations; stem cell and genetic research; research to combat bioterrorism; scientific misconduct; conflicts of interest; commercialization and intellectual property; and the use of deception and placebos. Course will meet once per week for 2 hours throughout the semester. Grades will be given based on class participation and a series of group projects and individual short writing assignments. Offered as BETH 503, CRSP 603 and LAWS 5225.

CRSP 650. Capstone Experience. 3 Units.

The Capstone will provide hands-on experience in conducting clinical research. To complete the Capstone project the student will register for 3 credit hours and dedicate at least 160 hours over the course of a semester, typically 20 hours per week for 8 weeks. Under the guidance of a Capstone Advisor the student will develop a Capstone project or internship/practicum, which may take diverse forms: A study project; Internship/Practicum: A combination of tasks necessary for the successful implementation of a study, such as attending team meetings, developing an IRB protocol, designing study forms, assisting with recruitment, study procedures, data management/cleaning, descriptive analysis, secondary analysis; Another format, with approval of CRSP director and Capstone Advisor.

CRSP 651. Clinical Research Scholars Thesis. 1 - 18 Units.

CRSP Thesis M.S.

CRSP 701. Dissertation Ph.D.. 1 - 9 Units.

Ph.D. Dissertation credits. Prereq: Predoctoral research consent or advanced to Ph.D. candidacy milestone.

RGME Courses

RGME 525. Current Topics in Regenerative Medicine. 2 Units.

Current Topics in Regenerative Medicine, will be an elective course in the newly approved Master's Program in Regenerative Medicine and Entrepreneurship. The objective of this course is for each student to develop a general understanding of concepts and current topics related to Regenerative Medicine, Stem Cell research, entrepreneurship and product development. -To expose students to principles in Cell Biology and Tissue Engineering relevant to the field -To review the current landscape and spectrum of topics which makes up the field of regenerative medicine -To explore current and emerging technologies supporting regenerative medicine research -To discuss federal regulatory and compliance issues related to clinical research and the development of therapeutics -To explore cellular manufacturing approaches for regenerative medicine products -Discuss ethical and societal issues related to regenerative medicine research and technologies

RGME 535. Foundations in Regenerative Medicine. 3 Units.

Foundations in Regenerative Medicine is a team-taught course using multiple faculty content experts. The objective of this course is for each student to develop a general understanding of the foundations and concepts related to Regenerative Medicine and Stem Cell research. -To expose students to foundational principles in Cell Biology and Tissue Engineering relevant to the field -To review the current landscape and spectrum of topics which makes up the field of regenerative medicine -To explore current and emerging technologies supporting regenerative medicine research -To discuss federal regulatory and compliance issues related to clinical research and the development of therapeutics -To explore cellular manufacturing approaches for regenerative medicine products -Discuss ethical and societal issues related to regenerative medicine research and technologies

RGME 545. Stem Product Biology, Bench to Bedside Development and Therapeutic Translation. 3 Units.

This course is a team - taught course using multiple faculty content experts. The objective of this course is for each student to understand the concept of stem cell biology from procurement to therapeutic development. This course will provide an overview of the regulatory framework, concepts, lab operations, and biologic techniques to support cell and regenerative medicine product manufacturing. To work in this emerging field, students must understand the scientific and regulatory development of biologic therapies as well as operational issues related to manufacturing in the cleanroom space under quality systems. The goals are to: 1) Develop an understanding of the infrastructure and compliance required to manufacture biologics for clinical use of stem cells. 2) Identify and critically analyze key operational issues related to clinical development and use of biologics from expansion to pre-clinical validation and therapeutic use. 3) Perform hands on activities using current techniques. 4) Discuss ethical and societal issues related to regenerative medicine research and technologies.

RGME 560. Regenerative Medicine Independent Study, Research Project. 3 Units.

The RGME 560 Independent Study-Research Project allows students to explore a topic of interest under the close supervision of a RGME program director and mentor. The course may include directed readings, applied work, assisting a faculty member with a research project, carrying out an independent research project, or other activities deemed appropriate. Regardless of the activities, the work must culminate in a formal paper. The specific course requirements are described in the Independent Studies Proposal form to be completed by the student, project mentor and program director prior to enrollment in the course. Prereq: RGME 535 and RGME 545.

RGME 565. Regenerative Medicine Independent Study, Internship. 3 Units.

The RGME 565 Independent Study-Industry Internship provides students with the opportunity to gain practical experience within an industry environment. Course objectives are: -Acquire knowledge of the industry sector in which the internship is completed. -Translate knowledge and skills learned in the classroom into a work environment. -Explore additional career options available with the designated industry sector. -Identify areas for future knowledge and skill development. Prereq: RGME 535 and RGME 545.