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CLNR 504 – Special Research in Clinical Research
Credit: Variable (Maximum 2 Hours)
This course will introduce the graduate student to the scientific inquiry process used in clinical and scientific research. This involves application of the scientific process including but not limited to: literature evaluation, literature search, project design, written and verbal skill development, data acquisition and analysis, use of web-based systems and data and project management.
CLNR 505 – Principles of Clinical Research
Credit: 2 Hours
This course will provide a broad understanding of Clinical Research definition, methodology, conduct and applications. The course will explore the basic elements of clinical research including the hierarchy of clinical trial design, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.
CLNR 515 – New Product Development
Credit: 2 Hours
New Product Development provides an introductory overview of the process of developing a molecule into a therapeutic agent, as well as an overview of the process from discovery through regulatory approval and introduction to the market place. This course will provide a perspective of the interaction required between Research & Development and Marketing in order to ensure product success in a regulated environment. It is designed to provide students with the background necessary to pursue a wide range of additional courses leading to degrees in clinical research.
CLNR 517 – Biostatistical Literacy
Credit: 2 Hours
The course seeks to provide students with a conceptual understanding of the most commonly utilized statistical methods in clinical research. A literacy course, the focus will be on the consumption, not the production, of statistics. That is, provided results (from published research articles and created examples) will be dissected, discussed, evaluated and interpreted. Limited computation is required in this course. Prerequisite: CLNR 324, MATH 160 or approved general Statistics course
CLNR 518 – Biostatistics II
Credit: 2 Hours
The second of the two-part biostatistics course sequence, the focus in this elective course will be on the production of statistics. Building off the conceptual learning that occurred in 517, the most common basic statistical methods utilized in clinical research will be revisited. Statistical software will be implemented as the students learn how to analyze, interpret and report data. Topics covered include descriptive and summary statistics, analysis of proportions and count data, one and two-sample means, one-way ANOVA, correlation, and linear and logistic regression.
Prerequisite: CLNR 517
CLNR 519 – Physical & Clinical Assessment
Credit: 2 Hours
This course is designed to introduce the student to the basic principles of medical terminology, history taking, the basic techniques of physical examination assessment, and diagnostic test data.
Prerequisite: BIOL 221 or equivalent Anatomy & Physiology course
CLNR 520 – Advanced Data Management
Credit: 2 Hours
This advanced course covers in detail topics such as the role of data management in clinical trials and the duties of the Clinical Data Coordinator. Topics include organization, collection, review, and tracking of data. Coding of adverse drug experiences, drugs and disease states, and standardized terminology are also considered.
Prerequisites: CLNR 505
CLNR 525 – Medical Ethics
Credit: 2 Hours
This course will use a combination of didactic lectures, interactive discussion, case presentations, and student presentations to explore the field of medical ethics. The course will primarily focus on medical ethics as it relates to clinical research. However, medical ethics in clinical practice may also be addressed. Historical cases as well as current events will be extensively used to highlight key principles of medical ethics. During the course, students will satisfy the requirement of human subjects training required for clinical investigators by the National Institutes of Health.
CLNR 527 – International Clinical Trials
Credit: 2 Hours
This course is intended for students who are contemplating a career in clinical research. The content presents fundamental knowledge of conducting global, international clinical trials.
CLNR 528 – Pharmacogenetics
Credit: 2 Hours
Population genetics, disease state prevalence, and population variances in response to drug therapy are covered in this course. The impact of pharmacogenetics on the future of clinical trials will be considered.
CLNR 529 – Epidemiology
Credit: 2 Hours
This course presents an overview of epidemiology and how the field augments clinical research. The course emphasizes an introduction to the application of epidemiological methods. The primary goal of the course is to orient students to the field of epidemiology and foster an appreciation for the methods used to do observational studies in real world settings.
Prerequisites: CLNR 505 & 517
CLNR 530 – Regulatory Affairs
Credit: 2 Hours
This course provides the student with an overview of the regulatory affairs universe, with emphasis on requirements for initiating clinical trials, developing pharmaceutical products, and gaining approval for worldwide marketing applications. Emphasis will be placed on the practical application of regulations in the commercialization of healthcare products. This will include data submission requirements, quality procedure regulations, marketing considerations, and post-approval requirements including safety reporting.
Prerequisites: CLNR 505 & 515
CLNR 535 – Clinical Trial Operations
Credit: 2 hours
In this course, students will explore the functional aspects of clinical trial operations and will be provided with the knowledge and operational skills necessary to develop, implement, and operationalize clinical trials. Topics covered include site selection and evaluation, trial management and clinical trial management systems, marketing and advertising for subject/patient recruitment, trial audits, trial reporting, and budget and contract negotiations. The goal of the course is to provide an opportunity for students to learn the contemporary processes of clinical trial operations consistent with ethical clinical development that meets quality, safety, and efficiency requirements.
Prerequisites: CLNR 505
CLNR 539 – Medical Genomics
Credit: 2 Hours
This course starts by teaching basic genomics and molecular biology. Attention then focuses on the benefits of this knowledge in biomedical research and medicine. Examples of topics discussed include pharmacogenomics and toxicology, an awareness of the ethical, legal, and social implications of genomic research, and the potential future implementation of Precision Medicine and Information-based Medicine.
CLNR 541 – Behavioral Medicine
Credit: 2 Hours
Behavioral Medicine is the interdisciplinary scientific field concerned with the development and integration of behavioral and biomedical knowledge. This knowledge can then be applied to prevention, diagnosis, and treatment of disease, and to preventive medicine strategies such as health promotion and wellness programs.
CLNR 550 – Introduction to Public Health
Credit: 2 Hours
The course provides a comprehensive examination of the basic and critical issues in public health for pharmacists. The course content includes a basic knowledge base of public health issues, an exploration of the various roles that pharmacy can provide in offering public health services, and examples of unique applications to pharmacy practice. Issues in public health care are examined both from the pharmacy perspective and the traditional public health viewpoint.
CLNR 552 – Scientific Communications
Credit: 2 Hours
This course briefly reviews fundamental communication skills, and then teaches scientific communication in both written and verbal forms. Regulatory documentation, abstracts, posters, manuscripts, and professional reports are covered. Oral presentation skills are also covered. Interpersonal skills are developed in team project work.
CLNR 555 – Special Populations in Clinical Research
Credit: 2 Hours
This course will cover topics and issues associated with conducting clinical research in special populations and vulnerable populations. The special populations reviewed will include pediatrics/adolescent, geriatrics, obstetrics/women issues, and ethnic minorities. Current regulatory mandates and guidance will be covered and issues unique to each special population will be discussed such as measurement challenges, recruitment, ethics, and IRB issues. The course will use a case study approach with examples based on current literature and clinical research approaches to each of the special populations examined.
CLNR 559 – Advanced Managing & Monitoring of Clinical Trials
Credit: 2 Hours
This advanced course is designed to provide an in depth introduction to the principles of managing and monitoring clinical trials. The varied environments in which clinical research is conducted are described and the roles of the different personnel involved in a clinical trial will be detailed. Managing & Monitoring Clinical Trials will introduce students to the elements of clinical trial protocols and data collection strategies. The course will provide an overview of regulations relevant to clinical trials including responsibilities of sponsors, investigators, institutional review boards, and contract research organizations. In addition, the course will cover selection of investigators, conduct of investigator meetings, procedure for site monitoring visits (study initiation, periodic monitoring, close-out and study termination), patient enrollment issues, safety monitoring, case report form review, and data management. Students will become familiar with Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), the quality assurance process (QA), and FDA audits. The course uses both lecture and online exercise formats.
Prerequisites: CLNR 505
CLNR 560 – Pharmacoeconomics
Credit: 2 Hours
This course is designed to introduce and familiarize students with the terminology, concepts, methods, assumptions, controversies, strengths and practical applications of pharmacoeconomic research.
CLNR 561 – Healthcare Economics
Credit: 2 Hours
This course will give participants an in-depth international perspective on healthcare economics. This perspective will be delivered by starting at the macro-economic, global level and then narrowing the focus of study to numerous national healthcare systems and landmark case studies. All case studies will be aimed at measuring the economic impact of specific healthcare crises. Each case will be preceded by the description of cultural values that impact healthcare delivery and government response in the event of a healthcare crisis.
CLNR 562 – Preclinical Drug Development
Credit: 2 Hours
This course provides students with an overview of the process of classical and modern drug development. The course will also provide a perspective of the interaction of research, development and marketing activities in a regulated environment. Particular emphasis is placed on promising approaches expected to lead to novel therapies and drug delivery systems within the next decade. A focus on illustrating future therapeutic targets and drug delivery systems is included.
CLNR 566 – Advanced Study Design & Analysis I
Credit: 2 Hours
This course presents a selection of study designs and statistical analyses that are most relevant to clinical research. The course will also present research question development, endpoints, database utilization and sample size calculation. The course emphasizes the application of these topics beyond just understanding the concepts. The role of clinical research in providing the evidence for Evidence-based medicine is considered. The primary goal of the course is to present the concepts that are crucial to prepare students for CLNR 690/695 Research Project I/II, and develop the knowledge for the central importance of statistical thinking in clinical research (from initial conceptualization of the study, through design, statistical analysis plans, statistical analysis, and interpretation), rather than to become experts in computation.
Prerequisite: CLNR 517
CLNR 568 – Project Management
Credit: 2 Hours
This course will introduce the general concepts of professional project management that should be applied while managing projects in several industries. The full life cycle of a project will be studied including project initiation, planning, execution, control and closeout. The project manager’s role in developing and maintaining the timeline, budget, and quality of a project will be defined. Students will be exposed to the principles of project management as it applies specifically to clinical research. While management of an individual clinical trial will be covered, the broader perspective of managing new drug product development projects in the pharmaceutical industry will be a major focus. In the latter, the project manager integrates basic research, pharmacology, toxicology, chemical development, analytical development, pharmacokinetics, metabolism, clinical research, and marketing aspects for delivering a new product to the marketplace.
Prerequisite: CLNR 505 & 535
CLNR 573 – Evidence-Based Medicine
Credit: 2 Hours
This course will trace formulation of relevant questions from clinical cases through the methodology required to search the clinical literature for critical information. Students will be exposed to the process of evaluating the validity and usefulness of this information in order to incorporate it into clinical practice.
Prerequisites: CLNR 505 & 517
CLNR 574 – Integrated Drug Safety
Credit: 2 Hours
This course provides students with a comprehensive introduction to the many facets of contemporary pharmaceutical and biologic drug safety. A lifecycle development approach is taken, whereby discussions of drug safety considerations during in silico simulation modeling, drug discovery, in vivo and in vitro nonclinical research, pre-approval clinical research, and post marketing surveillance are fully integrated.
CLNR 581 – Pharmaceutical Compliance & Quality Assurance
Credit: 2 Hours
This course is designed to provide an overview of the process of compliance and quality assurance activities within the Pharmaceutical Industry. Emphasis will be placed on auditing fundamentals, audit processes and tools, quality program management as well as FDA compliance activities. Students may be exposed to a variety of industry experts during the course. Emphasis will also be placed on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Students will gain a practical knowledge of Quality as a scientific discipline.
Prerequisites: CLNR 505 & 530
CLNR 593 – Leadership Development
Credit: 2 Hours
This course is intended for students who are contemplating a management/leadership career track. The lectures present fundamental skills of organizational behavior and leadership that are essential to effectively managing and leading both direct reports and project teams. The course involves lectures supported by video presentations, group discussion, and role play. Participant materials can be retained by the student for future use/reference in the workplace. The course contains both theoretical content, as well as an examination of processes involved in human behaviors in the healthcare organizational setting. Due to the heavy emphasis on process, participation and group-intensive instructional approaches are used in the course. There are three primary student goals for the course: demonstrate mastery of the content as specified in the course objectives, apply the theories to case studies, and develop an understanding of your own managerial style.
CLNR 595 – Bioterrorism & Mass Public Health Threats
Credit: 2 Hours
This course provides an overview of current issues related to bioterrorism and mass threats to public health. Details of specific risks of threat entities and their treatment will be taught. An emphasis is placed on response planning and preparation. Cross listed as PHAR 595
CLNR 606 – Clinical Research Seminar
Credit: 2 Hours
This seminar is intended to assist the student in developing critical thinking skills in clinical research design and analyses of data. The course will reinforce learning of experimental methods in clinical research by analyzing manuscripts in the published literature. Students will learn criteria for quality that will allow them to distinguish those studies with the strongest validity. They will apply statistical methodology and knowledge of study design that they acquired in previous courses. Students will develop an understanding of the limitations of data and study design. The skills developed in this course will assist those students who will be writing their own manuscripts. The course will also prepare students to report on their research project.
Prerequisites: CLNR 505, 517 & 566
CLNR 690 – Research Project I
Credit: 2 Hours
This course is the first part of the four-part Research Project course, which comprises CLNR 690, 691, 694, and 695. The student will utilize prior didactic experience in the Clinical Research Program to propose, design, and conduct the research project. The research project must involve patient- oriented research, including: epidemiologic and behavioral studies, health outcomes research, and /or health services research. The project will be conducted under the supervision of the Course Director. Students will have an internal faculty advisor who is a full-time faculty member in the Department of Clinical Research, as well as a Statistician faculty member of the Department of Clinical Research assigned to advise them throughout the project. In this course, students will develop and submit a written Research Proposal describing their research question(s) and research hypotheses. In later research project courses, the student will develop a full Study Protocol describing the methodology that will be employed in the study, and then ultimately conduct the study and present study results.
Prerequisites: All core courses except listed co-requisites, 3.0 GPA required
Acceptable Co-requisites: CLNR 525 & 535
CLNR 691 – Research Project II
Credit: 2 Hours
This course is the second part of the four-part Research Project course, which comprises CLNR 690, 691, 694, and 695. The student will utilize prior didactic experience in the Clinical Research Program to propose, design, and conduct the research project. The research project must involve patient- oriented research, including: epidemiologic and behavioral studies, health outcomes research, and /or health services research. The project will be conducted under the supervision of the Course Director. Students will have an internal faculty advisor who is a full-time faculty member in the Department of Clinical Research, as well as a Statistician faculty member of the Department of Clinical Research assigned to advise them throughout the project. In this course, students will further develop a written Research Proposal, and once approved, will develop this into a full Research Protocol. In later research project courses, the student will ultimately conduct the study and present study results.
Prerequisites: CLNR 690
CLNR 694 – Research Project III
Credit: 2 Hours
This course is the third part of the four-part Research Project course, which comprises CLNR 690, 691, 694, and 695. The student will utilize prior didactic experience in the Clinical Research Program to propose, design, and conduct the research project. The research project must involve patient- oriented research, including: epidemiologic and behavioral studies, health outcomes research, and /or health services research. The project will be conducted under the supervision of the Course Director. Students will have an internal faculty advisor who is a full-time faculty member in the Department of Clinical Research, as well as a Statistician faculty member of the Department of Clinical Research assigned to advise them throughout the project. In this course, students will finalize their Research Protocol, obtain IRB approval /exemption (as appropriate) and develop a Data Analysis Plan for their project. In the last research project course, the student will analyze their data and present study results.
Co-requisites: CLNR 518, 567, & 691
CLNR 695 – Research Project IV
Credit: 2 Hours
This course is the fourth part of the four-part Research Project course, which comprises CLNR 690, 691, 694, and 695. The student will utilize prior didactic experience in the Clinical Research Program to propose, design, and conduct the research project. The research project must involve patient- oriented research, including: epidemiologic and behavioral studies, health outcomes research, and /or health services research. The project will be conducted under the supervision of the Course Director. Students will have an internal faculty advisor who is a full-time faculty member in the Department of Clinical Research, as well as a Statistician faculty member of the Department of Clinical Research assigned to advise them throughout the project. In this course, students will validate study data, conduct their statistical analysis, present study results, and write/ submit a final Study Report.
Prerequisites: CLNR 694