Clinical Research

Courses

CR 500S Epidemiology 3.0 Credits

Epidemiology is at the core of research professions as it is the study of the distribution, determinants, and the course of health related events in populations, and the efficacy and effectiveness of prevention and intervention strategies.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 501S Emerging Trends in Medical Device History 3.0 Credits

The goal of this course is to focus on the various trends that impact the research and development process inherent in the medical device industry. Case studies representing several therapeutic categories will be discussed from a business, medical scientific, ethical, regulatory and bio-medical engineering perspective.

College/Department: COM School of Biomedical Sciences & Professional Studies

CR 505S Ethical Issues in Research 3.0 Credits

Students explore ethical issues to sound clinical research, review the foundations of regulations for clinical investigations, and to better understand the operational imperatives of Good Clinical Practices.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 508S Medical Device Combination Product Regulation 3.0 Credits

This course provides a comprehensive overview of medical device and combination product (drug-device, drug-biologic) regulation. The primary focus will be how medical devices and combination products are regulated by the U.S. Food and Drug Administration (FDA). Topics that will be covered include: (1) FDA's organizational structure, responsibilities, and resources for medical device and combination product regulation; (2) an overview of the laws, regulations, and regulatory processes that govern medical devices and combination products; (3) regulatory and administrative requirements for medical devices throughout the full product life-cycle, including premarket review, postmarket requirements, and enforcement programs.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 510S Sponsored Projects Finance 3.0 Credits

The study of managing and monitoring external funding sources for research projects. Topics include: rules and regulations, proposal preparation and submission, cost accounting standards, salaries and benefits of staff, direct and indirect costs, the costing of equipment and facility use.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 511S The History of Misconduct in Biomedical Research 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 512S Fundamentals of Academic Research Administration 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 513S Business Processes and Contemporary Concerns in Pharmaceutical R & D 3.0 Credits

Bringing a new compound or device through a successful product launch in the bio-pharma or device industry is hugely expensive. Failures occur when information and business processes are inadequately used or inappropriately applied. This course will provide an overview of the processes most critical to launch from both clinical and business perspectives. Students will understand the R and D process as if they were participating in development and launch of new compounds, devices (including diagnostics), and biosimilars.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 514S World Wide Regulatory Submissions 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 515S Intro to Clinical Trials 3.0 Credits

This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 518S Clinical Trial Budgeting 3.0 Credits

The overall cost of drug development has increasingly become a controversial subject with estimates varying from hundreds of million to over a billion dollars. One of the larger components contributing to this is the cost of clinical trials required for regulatory approval. Accuracy in the development of clinical trial budgets is crucial for both small and large pharmaceutical companies. The budget variance for clinical studies, from forecast to actual costs, averages about 10%. Overestimating the cost of clinical studies is equally problematic and results in wasted resources and a higher opportunity cost.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 520S Applications of Clinical Research Biostatistics 3.0 Credits

Examines role of the statistician in clinical research. Course includes a discussion of the language of statistics to facilitate communication with the clinical research project team, basic methods of describing data, fundamentals of probability, simple models and methods of parameter estimation and statistical software packages for reporting data.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 523S Current Issues in Review Boards 3.0 Credits

Review boards form the basis for careful review and oversight of clinical research. This course will look in detail at the regulatory requirements of review boards as related to clinical research, as well as the roles and responsibilities of review boards and other associated topics. The differences between the areas of responsibility of review boards, the Office of Human Research Protections (OHRP), and the Office of Research Integrity (ORI), as well as data safety monitoring, subject compensation and other topics will be covered. The educational elements of this course are based upon the federal regulations, the procedures, and the practices of review boards with particular attention paid to the organization, the research review requirements and continuing review, as well as other pertinent topics.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 525S Scientific Writing and Medical Literature 3.0 Credits

This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 527S Clinical Data Management 3.0 Credits

This course will provide the student an opportunity to learn and understand the regulatory and scientific components of clinical data management. In addition, the essential documents utilized throughout the clinical data management process will be examined and incorporated into the weekly lectures. This course is vital to understanding and applying the principles and practices of clinical data management as they are applied within the prescribed federal and global regulatory framework. To any company that develops healthcare products, the lifeblood of their product line and corporate existence depends entirely on the quality of the respective clinical data that is generated.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 530S Tech Transfer 3.0 Credits

The study of leveraging research capabilities with the marketplace and communicating research results for public benefit. Topics to include: the identification, management, development and commercialization of marketable research and technologies. Additional topics include patents and licensing.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 535S Current Federal Regulatory Issues in Biomedical Research 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 536S Clinical Project Management 3.0 Credits

Project management has been a well‐established practice outside the pharmaceutical industry for many decades. However, with ever‐increasing pressures of competitors, regulatory requirements, generic drugs and medical device innovations, its utilization is essential. It is more important than ever to use project management techniques to get products to market because, as we all know, “time is money”. This course will explore a strategic approach to pharmaceutical and medical device project management.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 541S Patient Recruitment and Informed consent 3.0 Credits

Clinical trials represent the link between scientific discovery and medical effectiveness. Hundreds of innovative therapies are developed in the laboratories, but few make it past early development, if at all. Clinical trials today can cost hundreds of millions of dollars and take years to research. New clinical research starting for pharmaceuticals and medical devices is on the increase. Investigational New Drugs (IND) submissions have been growing steadily over the past several years. In order to support the increase in research, it becomes more imperative to accelerate patient recruitment and enrollment. However promising new drugs and devices may be, the research cannot move forward without enough subjects who are willing to participate and who will remain for the duration of the study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 545S Pharmaceutical Law 3.0 Credits

Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 546S Clinical Outsourcing 3.0 Credits

This course will provide an overview of the pertinent aspects of and current issues in outsourced clinical research and development. The course will identify predominant outsourcing models and strategies, discuss how effective outsourcing relationships may be initiated and maintained through measurement and action on key operational, quality and relationship metrics, and explore perspectives on how the clinical outsourcing landscape will continue to evolve in years to come. While concepts pertaining to procurement, quality and performance management are covered, it is not expected, nor required that students be fluent in these disciplines.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 550S Leadership Skills 3.0 Credits

This course is an in-depth analysis of specific human capital, organizational behavior and project management issues facing research facilities as they pertain to larger, integrated organizations. Selected topics include: high impact communications, negotiating, motivation and recognition.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 551S International Regulatory Affairs 3.0 Credits

Overview & analysis of the medical product regulatory processes within the world’s major markets, with an emphasis on pharmaceutical requirements. The key strategies required from preclinical product development & marketing approval - post-approval of medical products in the United States, European Union, & other markets will be compared & discussed. This course will cover the salient features of international regulatory affairs; the World Health Organization & international organizations; international law General Agreement on Tariffs and Trade & Trade-Related Aspects of Intellectual Property Rights & its impact on medical products; international regulatory agencies; & product development, marketing authorization, & post-approval requirements for pharmaceuticals, biologics,medical devices, & food & cosmetics.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 555S Compliance & Monitoring Issues 3.0 Credits

This course focuses on measuring and improving clinical trial performance as a means of saving time and money, while ensuring quality health care, as well as offering to patients both safe and effective therapeutic products. Students are required to develop milestone efficiencies through the use of process-performance data.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 565S Contemporary Issues in Human Research Protection 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 570S Principles and Practice of Pharmacovigilance 3.0 Credits

This course is an introduction to the ethical, clinical, and regulatory complexities of medication safety and matters thinking skills for improving the quality and effectiveness of drug safety monitoring for both the pharmaceutical industry and its impact on the public.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 600S Designing the Clinical Trial 3.0 Credits

Designers and ethical, clinical, strategic issues surrounding clinical drug research are the focus of this course. Topics include design of trials for Phases one though four, an overview of the statistical component of a clinical trial, monitoring of the trial, and managing clinical data.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit
Prerequisites: CR 515S [Min Grade: C]

CR 609S Innovative Product Development 3.0 Credits

This comprehensive course provides a solid foundation in new therapeutic product research and development for the subsequent courses in the CROM program. This course focuses on the process of drug and medical device development from early research, discovery, and product formulation, through the federal requirements form proving safety and efficacy.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 612S Fundamentals of Compliance 3.0 Credits

The study of the federal bodies and regulations that govern research. Topics include: the rules and regulations surrounding HIPAA and how it affects research on human subjects, the history and current role of the FDA, IACUC, and the IRB within the research arena.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 614S Introduction to Clinical Pharmacology 3.0 Credits

This course will provide a comprehensive overview of clinical pharmacology, pharmacokinetic/pharmacodynamic principles, and translational science as they pertain to drug development in the pharmaceutical industry. The objective of the course is to provide the student with an understanding of how clinical pharmacology principles and regulatory guidance are applied in transitioning a new molecule into human testing, as well as how product labeling for the final product is developed, based on the attributes of the drug.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.

CR 616S Intro to Therapeutic Products 3.0 Credits

This course is designed to provide an overview of the diverse marketing and advertising practices and strategies of the pharmaceutical industry and their impact on the professional healthcare infrastructure, as well as on the healthcare recipient population. Students will be encouraged to develop skills to crucially evaluate the marketing techniques of the pharmaceutical industry.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.

CR 617S Informatics in Pharm Res & Development 3.0 Credits

Using a combination of printed materials, case studies, literature reviews, and on-line discussions, this course will cover past and present contributions of computer applications in pharmaceutical research and development. In addition, the student will be challenged to portend where technological advances may prove to be strategically beneficial in the future.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.

CR 620S Biotech/Research 3.0 Credits

The study of the history, use and progression of biological techniques developed through basic research and now how it is applied to research and product development.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 625S Health Policy and Economics 3.0 Credits

The study of the development, analysis and communication of economic data in the context of clinical research.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 630S Trans Research 3.0 Credits

The study of the conversion of research into information, resources or tools that can be used by the public to improve overall health and well-being. Students will learn the management and applicability issues in converting basic research discoveries and innovative ideas into clinical trials that lead to better treatment.

College/Department: COM School of Biomedical Sciences & Professional Studies

CR 631S Applications of Clinical Research Biostatistics II 3.0 Credits

This course will cover in some in-depth biostatistics topics of interest in clinical trials that are not usually covered in introductory biostatistics courses. The course is designed to focus on learning and understanding biostatistics methods used in the clinical research realm of the pharmaceutical industry. Drug development is the process of finding and producing therapeutically useful pharmaceuticals and of turning them into high-quality formulations of safe and effective medicines, while delivering valuable information about their doses and dosing intervals, anticipated effects and adverse events.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit
Prerequisites: CR 520S [Min Grade: B]

CR 633S Quality Assurance Audits 3.0 Credits

This course provides the student with an in-depth knowledge of compliance and quality assurance issues as well as the related regulations inherent in the drug development process. Students develop auditing plans and strategies for conducting compliance inspections.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 635S Strategic Planning 3.0 Credits

This course introduces the student to the project management and planning process. Topics include: project communications, leadership, objectives, scope, success criteria, procurement, cost estimating, control mechanisms, developing mission statements and devising strategies that turn vision into reality. May be repeated twice for credit.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR I699S Independent Study in Clinical Research 1.0-12.0 Credit

Self-directed within the area of study requiring intermittent consultation with a designated instructor.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

CR T580S Special Topics in Clinical Research 1.0-12.0 Credit

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

CR T680S Special Topics in Clinical Research 1.0-12.0 Credit

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

CR T780S Special Topics in Clinical Research 1.0-12.0 Credit

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

CR T880S Special Topics in Clinical Research 1.0-12.0 Credit

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

CR T980S Special Topics in Clinical Research 1.0-3.0 Credit

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit

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