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.
Repeat Status: Not repeatable for credit
CR 501S Emerging Trends in Medical Device Regulation 3.0 Credits
The Internet of Things poses an evolving set of challenges to the research and development of both conventional and digital medical devices. For example, equipment once found only in hospitals and doctors’ offices are increasingly available to the public. This course examines the social, regulatory and scientific factors that define the development of digital and conventional medical devices even as the distinctions between patient and consumer disappear.
Repeat Status: Not repeatable for credit
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.
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.
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.
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.
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.
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.
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.
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.
Repeat Status: Not repeatable for credit
CR 525S Scientific Writing and Medical Literature 3.0 Credits
This course teaches the medical professional how to read for understanding and how to evaluate the validity of information found in a medical or scientific paper. The course offers students an understanding of the publishing process, how to publish an academic paper. The class explores the basics of writing a review of the medical literature. In addition, students learn how to recognize, enjoy, and employ various types of medical writing in their work.
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.
Repeat Status: Not repeatable for credit
CR 535S Current Federal Regulatory Issues in Biomedical Research 3.0 Credits
This course explores how the rapid pace of scientific discovery and the changing ways in which patients, researchers, policymakers and the public interact are forcing a never-ending reassessment of how to govern biomedical research. While most core principles remain in place, this course examines where and how innovation requires a new look at existing approaches.
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.
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.
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.
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.
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.
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.
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.
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.
Repeat Status: Not repeatable for credit
CR 571S Health Information Technology in Biomedical R&D 3.0 Credits
This course focuses on the challenges and opportunities in the development and use of health information technology in facilitating R&D and encouraging patient engagement. The course provides an overview of the regulatory requirements of information technology in support of healthcare research and biomedical product development. It includes a focus on the privacy and data security and interoperability mandates. This course also examines the dynamic environment in which medical device product research is conducted because of the use of information technology, the adoption of software applications designed for the mobile marketplace and the blurring of the distinctions between patients and consumers.
Repeat Status: Not repeatable for credit
CR 573S Patient Generated Data in Clinical Research 3.0 Credits
This course will provide an overview of the use of patient-generated data in clinical research and development. The course will describe foundational elements for use of patient-reported data in clinical research, as well as the operational considerations for collecting patient-generated data and working with solution providers offering technology and services for the same. While we will touch upon technical concepts as part of the course material it is not expected, nor required that students be fluent in these disciplines beyond what is covered in course materials.
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.
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.
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.
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.
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.
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.
CR 620S Regulatory, Scientific and Social Issues Affecting Biotech Research 3.0 Credits
Biotechnology is among the most ambitious and controversial areas of medical research. This course delves into how FDA approaches clinical research for this wide range of products at a time when policymakers focus not only on genomics, but on personalized medicine and the use of big data, software and social policy.
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.
Repeat Status: Not repeatable for credit
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.
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.
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.
Repeat Status: Not repeatable for credit
CR 637S Risk Management in Clinical Research 3.0 Credits
This course will provide an overview of the foundational concepts and practices of risk management and current challenges and opportunities in applying risk management and risk-based approaches in clinical research and development and as described in applicable regulatory guidance. The course will identify pertinent tools and strategies for assessing and measuring risk, as well as defining plans for risk controls and risk response. Relevant case study examples will be presented for synthesis and illustration of concepts in practice.
Repeat Status: Not repeatable for credit
CR 639S Healthcare Inequities in Biomedical Research 3.0 Credits
The course examines the existence of systemic racism, sexism and other forms of bias and discrimination in the conduct of biomedical R&D that have resulted in healthcare disparities and inequities. Students will learn to identify the various forms of bias and discrimination that are and could be embedded in the way biomedical researchers create and access data used to make decisions about product development. Students also will be introduced to the history of healthcare inequities and bias in the healthcare system and in medical research to help them understand why people of color and of differing ethnicities and cultures and those in the LGBQT+ communities harbor mistrust of the health system.
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.
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.
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.
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.
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.
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.
Repeat Status: Can be repeated multiple times for credit