Courses

MS in Clinical Research Online

Courses

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, design of project, development of written and verbal skills, data acquisition and analysis, use of web-based systems and data and project management.

CLNR 505 – Principles of Clinical Research
Credit: 1.5 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 510 – Pharmacokinetics
Credit: 2 Hours
Pharmacokinetics involves the rates of liberation, absorption, distribution, metabolism, and excretion of drugs and chemicals in the body. A basic course in pharmacokinetics examines these principles from the mechanistic, mathematical, and graphical perspectives, and provides a scientific approach to rational drug selection and therapy. The principles governing liberation, absorption, distribution, metabolism, and excretion will be presented. The rates or kinetics of these processes, and the mathematical methods associated with pharmacokinetics, will be examined. Application of theoretical principles will be extended to examine drug product equivalency, dosage regimen design, and dosage adjustment in renal and/or liver failure. 
This course is co-listed as PHAR 410.
Prerequisites: PHAR 304 & 314 
Permission of instructor required.

CLNR 515 – New Product Development
Credit: 1.5 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 518 – Experimental Design & Biostatistics

Credit: 3 Hours
This course is intended to provide students with the basic knowledge of estimation, hypothesis testing, sample size and power analysis, and other selected statistical methods including two sample tests, contingency table inference and odds rations, one-way analysis of variance, simple linear and logistic regression and multivariate regression. Applications of the methodology and interpretation of results is the primary focus of the course.
Prerequisite: CLNR 324 or equivalent Statistics course

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 & 515

CLNR 525 – Medical Ethics
Credit: 3 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 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.
Prerequisites: CLNR 505, 515 & 518
This course is co-listed as PHAR 594 and PHSC 564.

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, 515 & 518

CLNR 530 – Regulatory Affairs
Credit: 3 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 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: 3 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 in class exercise formats.
Prerequisites: CLNR 505 & 515

CLNR 560 – Pharmacoeconomics
Credit: 3 Hours
This course is designed to introduce and familiarize students with the terminology, concepts, methods, assumptions, controversies, strengths and practical applications of pharmacoeconomic research.
This course is co-listed as PHAR 561.

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.
Prerequisites: CLNR 505 & 515

CLNR 566 – Advanced Study Design & Analysis
Credit: 3 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 505, 515 & 518

CLNR 568 – Project Management
Credit: 2 Hours
This course will introduce the generic 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 project 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 & 559

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, 515 & 518

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, preapproval clinical research, and postmarketing surveillance are fully integrated.

CLNR 578 – Biopharmaceutics
Credit: 3 Hours
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
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, 515, 530 & 559

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:  3 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, 515, 518 & 566

CLNR 690/690L – Research Project I
Credit: 2.5/1 Hours
This course is the first part of the two-part Clinical Research Project course, which comprises CLNR 690/L and CLNR 695/L. These courses are typically taken in two consecutive semesters and are intended to provide students with the opportunity to conduct a research project that entails practical application of knowledge previously obtained from the didactic courses preceding this course. Students will utilize prior didactic experience in the Clinical Research Program to propose, design, and conduct a research project. Students may engage in a research project that involves multiple disciplines within clinical research, or alternatively, the student may choose to delve deeply into issues involving a single discipline. During CLNR 690/L students will submit a written Research Proposal describing a primary research question, appropriate research hypotheses, and a Study Protocol describing the methodology that will be employed in the study as well as the analytical methods that will be employed. Full acceptance status in the program, a minimum cumulative GPA of 3.0 and completion of all required core courses prior to beginning Research Project I is mandatory. 
Acceptable co-requisites:  CLNR 525 & 606  

CLNR 695/695L – Research Project II
Credit: 2.5/1 Hours
This course is the second part of the two-part Clinical Research Project course, which comprises CLNR 690/L and CLNR 695/L. During Research Project II (CLNR 695/L) the student will implement the research, analyze the data and write a Research Report. During the execution of their study, students can seek guidance from the team of expert researchers that work closely with the Course Director. Finally, the student will present and defend their project to course colleagues and possibly external advisors, faculty and appropriate representatives from Campbell University. Prerequisite: CLNR 690/690L.  These courses are restricted to students who have successfully completed all required MSCR courses listed below or who have received special permission from the Course Director. Students must have achieved a GPA of 3.0 or better in the required Clinical Research courses prior to beginning the research project. Students must also have gained full acceptance into the program before starting the research project.