Courses

CLNR 324 - Experimental Design & Biostatistics

4 hour(s)

The application of statistical analyses to the design, conduct, and interpretation of pharmaceutical research, development, testing, and manufacturing is provided in this comprehensive course.

CLNR 326 - Principles of Clinical Biochemistry

2 hour(s)

Concepts in basic Biochemistry will be covered. Emphasis will be placed on the following topics: 1) structure, function, and their relationship: 2) proteins: 3) enzymes; 4) metabolism: and 5) biological information flow.

CLNR 328 - Introduction to Pharmacology

4 hour(s)

The basic principles of pharmacology and toxicology are covered through discussion of the responses of biological systems to drugs and chemicals. The course also considers the absorption, distribution, metabolism, and excretion of xenobiotics and how these factors relate to drug action. Prerequisite: BIOL 221.

CLNR 330/430 - Regulatory Affairs I & II

2 each hour(s)

These introductory courses provide the student with an overview of the regulatory requirements and the underlying principles for gaining approval of worldwide marketing applications. Students may be assigned to groups in order to develop an understanding of the teamwork necessary to effectively function in the regulatory process. Information on late phase clinical investigations, subsequent to IND filing, marketing considerations, and periodic safety reporting will be presented. Student groups will be expected to make presentations, which will include the incorporation of a variety of realistic issues and unexpected developments that arise during the review of their applications. Prerequisites: CLNR 463 and 464.

CLNR 334/336 - Scientific Literature Seminar I & II

1 each hour(s)

Students are introduced to literature searching and critical analysis techniques in this series of courses. The courses promote the formulation of critical thinking approaches. Special emphasis is placed on communication techniques. Students apply their knowledge and skill in the form of written and oral presentations developed by researching the current pharmaceutical and biomedical literature. Prerequisite: CLNR 451.

CLNR 363 - New Product Development

1.5 hour(s)

This introductory course provides an overview of the broad field of new product development. While primarily designed to give students the basic knowledge required for subsequent courses in clinical research, it will also support the students’ consideration of subsequent career choices. The course will cover the process of development from early research, discovery, and product formulation, through the requirements for proving safety and efficacy. Marketing and promotional considerations necessary for the successful introduction of a product into the marketplace will be discussed, as will the external influences that may alter the development process in the global market place of the twenty-first century.

CLNR 364 - Principles of Clinical Research

1.5 hour(s)

This introductory course will provide a broad understanding of Clinical Research-definition, methodology, conduct and applications. The course will explore basic elements of clinical research including the hierarchy of clinical trials, clinical trial design, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.

CLNR 365/465 - Managing & Monitoring Clinical Trials I & II

2 each hour(s)

These introductory courses are designed to provide a theoretical and practical overview of the principles of managing and monitoring clinical trials. The multiple practice environments in which clinical research is conducted will be described and the various roles of involved personnel will be discussed Managing & Monitoring Clinical Trials will introduce students to the elements of clinical trial protocols and data collection strategies (e.g. case report forms), and 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, site monitoring visits (for study initiation, periodic monitoring, 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. Prerequisites: CLNR 463 and 464.

CLNR 379/379L - Physical & Clinical Assessment & Lab

2 hour(s)

This course is designed to introduce students to the basic principles and techniques of history taking and physical and clinical assessment. Students in this course have an opportunity to develop the basic skills necessary to understand lab values and assessment parameters. Prerequisite: BIOL 221

CLNR 416 - Senior Seminar

1 hour(s)

Senior Seminar provides a forum through which students chronicle their B.S. internship experience. Students present an overview of the clinical site at which they worked and provide a synopsis of their role in the organization. Students present findings from their internship to the faculty and other students. Co-requisite: CLNR 420.

CLNR 420 - Senior Internship

14 hour(s)

The full-time internship provides practical experience at one or more clinical research sites. Students and participating institutions are matched to provide a comprehensive work experience. Prerequisite: Completion of all BSCR courses and at least a 2.0 major and cumulative GPA. Co-requisite: CLNR 416.

CLNR 442 - Interpersonal Skills

2 hour(s)

In this course, students will learn about the various factors involved in developing good interpersonal speaking and writing skills including: self-awareness, understanding individual differences, goal setting, listening and feedback, teamwork, leadership development and motivating others, delegation, negotiation, conflict resolution, interviewing, and presentation skills. The course will provide a forum for group discussions and writing exercises.

CLNR 450 - Data Management

2 hour(s)

This introductory course covers 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 463 and 464.

CLNR 451 - Scientific & Technical Writing

1.5 hour(s)

This required course is presented to assist students in skill enhancement in the areas of scientific and technical writing.

CLNR 474 - Biopharmaceutics

3 hour(s)

This course presents the biological and physiochemical factors of the body, drugs and dosage forms that influence drug availability, disposition, and pharmacological and toxicological responses. This course is co-listed as PHAR 314. Permission of instructor required.

CLNR 504 - Special Research in Clinical Research

Maximum 2 hour(s)

The purpose of this elective course is to introduce the MSCR student to methods of basic science and/or clinical research. This can involve the application of the scientific inquiry process, literature evaluation, development of teaching skills, data acquisition and analysis, and formal presentation of results. Two credits are equivalent to 6-8 hours per week of course activity.

CLNR 505 - Principles of Clinical Research

1.5 hour(s)

This advanced course will provide a broad understanding of Clinical Research definition, methodology, conduct and applications. The course will explore the elements of clinical research including the hierarchy of clinical trials, clinical trial conduct, and safety surveillance. Application of clinical trial knowledge to specific medical practice issues will also be explored.

CLNR 510 - Pharmacokinetics

2 hour(s)

This course is designed to provide an understanding of basic, clinically applicable pharmacokinetic formulas and the assumptions that are involved with their use in therapeutic drug monitoring. This course is co-listed as PHAR 410. Permission of instructor required.

CLNR 515 - New Product Development

1.5 hour(s)

This advanced course provides an in-depth analysis of the broad field of new product development. The course will explore the detailed process of development from early research, discovery, and product formulation, through the requirements for proving safety and efficacy. Marketing and promotional considerations necessary for the successful introduction of a product into the marketplace will be discussed, as will the external influences that may alter the development process in the global market place of the twenty-first century. Topics covered include drugs, devices, crop science, biotechnology, and others.

CLNR 518 - Experimental Design & Biostatistics

3 hour(s)

This course is intended to provide students with the basic knowledge of descriptive statistics, probability theory, hypothesis testing, and other selected statistical methods including parametric and non-parametric tests for differences in central tendency, paired comparisons, simple linear regression and one-way analysis of variance. Also discussed is the importance of appropriate statistical design in the development of experimental protocols.

CLNR 519 - Physical & Clinical Assessment

2 hour(s)

This course is designed to provide students to the principles and techniques of history taking and physical and clinical assessment. Students in this course develop the necessary skills to follow patients by understanding lab values and assessment parameters. Prerequisite: BIOL 221

CLNR 520 - Advanced Data Management

2 hour(s)

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 & 515.

CLNR 525 - Medical Ethics

3 hour(s)

As health care professionals, clinical researchers encounter a variety of problems that may compromise quality care and patient rights. This course is designed to enable students to approach ethical dilemmas objectively with an understanding of professional ethical responsibility. Students will learn skills in ethical reasoning necessary to promote the dignity of the patient. Ethical issues relevant to the clinical researcher such as selection of subjects, compensation, confidentiality, informed consent, termination of clinical trials, conflict of interest, and scientific integrity will also be covered. Students are expected to review current media issues that can impact class discussions.

CLNR 528 - Pharmacogenetics

2 hour(s)

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. Prerequisites: CLNR 328, 505, 515 and 518. This course is co-listed as PHAR 594 and PHSC 564.

CLNR 529 - Epidemiology

2 hour(s)

This course presents an overview of classic epidemiology and basic pharmacoepidemiology and how these fields augment clinical research. The course emphasizes introduction to the application of epidemiological methods in assessing pharmacological effectiveness and safety. The primary goal of the course is to orient students to the field of pharmacoepidemiology and foster an appreciation for the methods used to study drug exposure in “real world” settings. Prerequisites: CLNR 505 and 518.

CLNR 530 - Regulatory Affairs

3 hour(s)

This course will provide the student with in-depth coverage of the regulatory requirements and the underlying principles for gaining approval of worldwide marketing applications. Students will be assigned to groups in order to develop an understanding of the teamwork necessary to effectively function in the regulatory process. Emphasis will be placed on late phase clinical investigations, subsequent to IND filing, marketing considerations, and periodic safety reporting. Student groups will be expected to make presentations, which will include the incorporation of a variety of realistic issues and unexpected developments that arise during the review of their applications. Students will be expected to use the Internet as a research resource, and to communicate with fellow teammates by e-mail. Prerequisites: CLNR 505 and 515.

CLNR 539 - Medical Genomics

2 hour(s)

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

2 hour(s)

Behavior is a major contributor to many serious and chronic illnesses in society today, including heart disease, obesity, diabetes, and stress-induced diseases. The human and health costs of these diseases are enormous. Fortunately, behavioral factors and interventions can also be very powerful influences in disease prevention and health promotion. 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

2 hour(s)

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. This public health perspective, in the context of the Campbell mission, can tangibly: transfer from one generation to the next the vast body of knowledge and values accumulated over the ages; encourage creativity, imagination and rigor in the use of intellectual skills; and, equip students with superior vocational skills, productive insights, and professional integrity.

CLNR 552 - Scientific Communications

2 hour(s)

This course applies principles of communications as they relate to scientific data as well as communications in a scientific environment. Areas of study include negotiation skills, abstract development, poster development and presentation, communication barriers, professionalism, leadership, and others. Team and individual assignments as well as in and out of class activities are a requirement for the course.

CLNR 555 - Special Populations in Clinical Research

1 hour(s)

This course will cover topics and issues associated with conducting clinical research in special 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

3 hour(s)

This advanced course is designed to provide an in depth knowledge of the principles of managing and monitoring clinical trials. The multiple practice environments in which clinical research is conducted will be described and the various roles of involved personnel will be discussed. Managing & Monitoring Clinical Trials will introduce students to the elements of clinical trial protocols and data collection strategies (e.g. case report forms), and 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, site monitoring visits (for study initiation, periodic monitoring, 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. Course uses both lecture and in class laboratory formats. Prerequisites: CLNR 505 and 515.

CLNR 560 - Pharmacoeconomics

3 hour(s)

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

2 hour(s)

This course will help participants understand how to apply economic principle to health care problems. The class will concentrate on factors that distinguish the medical care market from other markets, including uncertainty, government regulation, insurance, and externalities. Students will pay particular attention to the way in which economists measure the costs and benefits of drug discovery and development. Furthermore, the demand for medical care and the supply and demand of health insurance will be analyzed. Finally, students will contrast medical care in the United States with care offered in other nations.

CLNR 562 - Preclinical Drug Development

2 hour(s)

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. Prerequisites: CLNR 505 and 515.

CLNR 566 - Advanced Study Design & Analysis

3 hour(s)

Building on the foundations laid by the first-year MSCR course in Experimental Design and Biostatistics, “Advanced Study Design and Analysis” gives students a greater understanding of Medical Statistics and the methodological considerations underlying study design. This facilitates their understanding of the central role of study design and statistical analysis in clinical research, which provides the evidence for Evidence-based Clinical Practice. A primary goal of the course is to highlight students’ awareness of the central importance of statistical thinking in clinical research, including initial conceptualization of the study, design considerations, statistical analysis, and clinical interpretation of results. Prerequisite: CLNR 518

CLNR 568 - Project Management

2 hour(s)

This course will introduce the concepts of project management that are utilized broadly in industries as diverse as aerospace and agriculture. The full life cycle of a project will be studied including planning, conducting, monitoring, analysis, and reporting. The project manager’s role will be defined in developing and maintaining the timeline, budget, and quality of a project. Students will be exposed to project management as it applies specifically to clinical research. While management of an individual clinical trial will be covered, the broader perspective of management of a new drug project in the pharmaceutical industry will be a major focus. In the latter, the project manager integrates basic research, secondary pharmacology, toxicology, chemical development, analytical development, pharmacokinetics, metabolism, clinical research, and marketing aspects for delivery of a new product to the marketplace. Prerequisite: CLNR 559.

CLNR 573 - Evidence-Based Medicine

2 hour(s)

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, 518 and 566.

CLNR 574 - Integrated Drug Safety

2 hour(s)

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, preapproval clinical research, and postmarketing surveillance are fully integrated. The title “Integrated Drug Safety” also reflects the integration of many complementary areas of investigation within the drug safety arena. This includes quantitative structure-activity relationships (QSARs), the use of stem cells to model pharmacotoxicity scenarios, improvements in statistical analysis of preapproval clinical trial data to better quantify benefit:risk balances, and the latest developments in pharmacoepidemiology and active drug safety surveillance. Cardiotoxicity and hepatotoxicity will be discussed predominantly, given that they are the primary causes of safety concerns leading to the termination of development programs and marketing withdrawals, but other toxicities will certainly be highlighted as appropriate.

CLNR 578 - Biopharmaceutics

3 hour(s)

This course presents the biological and physiochemical factors of the body, drugs and dosage forms that influence drug availability, disposition and pharmacological and toxicological responses. This course is co-listed as PHAR 314. Permission of instructor required

CLNR 581 - Pharmaceutical Compliance & Quality Assurance

2 hour(s)

This course will provide the student with in-depth knowledge of compliance and quality assurance issues and regulations in the drug development process. Students will work in groups on a variety of case studies and role-playing situations. Emphasis will be placed on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Students will also gain knowledge of FDA enforcement tools such as “Recalls,” “Warning Letters,” and restrictions placed on Clinical Investigators, and of problems with Direct to Consumer advertising, Internet Pharmacies, and other topical issues. Active FDA investigators will also make presentations. Prerequisites: CLNR 505, 515, 530 and 559.

CLNR 593 - Leadership Development

2 hour(s)

The purpose of this course is to identify and strengthen leadership skills. It uses a development approach focusing on how individuals become effective leaders by addressing the human element of enterprise within significant business situations. Students will strengthen their individual capabilities to advance their organizations strategically by rethinking their approaches to management, leadership, and leadership development. This course enables students to understand how to build and foster relationships as well as emphasizes the importance of those relationships in their professional and personal lives.

CLNR 595 - Bioterrorism & Mass Public Health Threats

2 hour(s)

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.

CLNR 606 - Clinical Research Seminar

2 hour(s)

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. Prerequisites: CLNR 505, 515, 518 and 566.

CLNR 690/690L - Research Project I

2.5/1 hour(s)

Research Project I is the first of two components that comprise the Research Project Course, the final component of the MSCR degree program. In this course, students utilize all of their previous learning and experiences to plan and execute a clinical research project under the supervision of the Course Director and a team of expert researchers. Students are offered the opportunity to collect original data or to work with an existing data set to answer a specific research question. Having decided on the nature of their research project, students will prepare a Research Protocol detailing the nature of their investigation, the research question, their plan for conducting the study, and the analytical strategy that will be employed to provide the answer to their research question. A minimum cumulative GPA of 3.0 is required in all MS in Clinical Research required courses. Co-requisite: CLNR 525 & CLNR 606. Full acceptance status in the program and completion of all core courses is required before beginning the research project.

CLNR 695/695L - Research Project II

2.5/1 hour(s)

During Research Project II, students conduct their research project and prepare a Research Report detailing all aspects of the investigation they have conducted. During the execution of their study, students can seek guidance from the team of expert researchers that work closely with the Course Director. Additionally, students prepare a short PowerPoint presentation of their study and results and, with appropriate guidance, give this presentation to a small audience of students and the faculty and research experts with whom they have worked with during their project. Prerequisite: CLNR 690/690L.