CLRA 6100 Introduction to Clinical Research (3 sem. cr.) 
This course provides an overview of the clinical research enterprise from a historical and evolutionary perspective, including examples of landmark studies and controversies. Students consider the context in which human clinical study is designed and implemented, with a focus on the components, general principles, and issues in clinical research; types and classification of research studies; formulation of research objectives and outcomes; definition and phases of clinical trial protocols; and the roles and responsibilities of the clinical research team and study sponsors. The course facilitates understanding of key medical terminology, including basic knowledge of health, wellness, and disease. The course also emphasizes development of critical thinking, as well as written, verbal, and interpersonal communication skills with attention to building competencies needed for student success within an online environment. Students begin development of a portfolio based on assigned learning activities, including a journal of interactions and interviews with clinical research administrators, an assessment of an organization’s culture, and the identification of management challenges in clinical research.

 

CLRA 6115 Pathophysiological Basis of Clinical Research (3 sem. cr.)
This course provides basic knowledge of normal and pathophysiological mechanisms of disease, providing the foundation for clinical assessment, decision-making, and management of clinical trials. Attention is given to interpretation of the rationale and procedures underlying the clinical research protocol in order to adequately assess the subject’s response to therapeutic interventions.

 

CLRA 6130 Ethical, Legal, and Regulatory Considerations in Clinical Investigations (3 sem. cr.)
This course explores the ethical, legal, and regulatory dimensions of human clinical research, as well as the variety of issues that arise in the conduct of clinical investigations. Ethical codes of conduct, regulatory requirements, and existing laws that govern clinical research are examined in the context of historical events that contributed to their development. Topics include recruitment and protection of human subjects; diversity and vulnerable populations in research; informed consent; privacy and confidentiality; the role of independent review committees (e.g., IRBs, IECs); and reporting of serious adverse events (SAEs). Other areas addressed are scientific integrity and misconduct, international research, relationships with industry, conflict of interest, intellectual property, and publications and authorship. Social and ethical implications of genetic technologies and research are also discussed.

 

CLRA 6145 Design and Conduct of the Clinical Protocol (3 sem. cr.)
This course provides an introduction to the basic elements of research design for clinical inquiry. Consideration is given to the methods and goals of clinical research; formulation of the research objective and hypothesis; identification of outcome measures; issues of reliability and validity; specification of the study population, with identification of exclusion and inclusion criteria; sample size calculation; randomization procedures; and documentation requirements; as well as data collection, analysis, and interpretation. Practical aspects of clinical trial management are presented, including the design of the Case Report Form (CRF), clinical laboratory management, outsourcing, and management of multicenter trials. The influence of health disparities and cultural diversity as factors that affect participation of subjects in clinical trials research is also addressed.

 

CLRA 6160 Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials (3 sem. cr.)
This course introduces the process and procedures of managing and monitoring a clinical trial from study initiation to closeout. The course examines essential elements of good clinical practice (GCP), how regulations relate to this concept, and how GCP affects the practical elements of conducting clinical studies. The basic tenets of GCP—including historical considerations, compliance, and recruitment of study participants—are addressed, with a focus on quality assurance and data safety monitoring boards (DSMBs), as well as the practical challenges of multicenter or large-scale trials, protocol management and amendments, audits, and reporting requirements. The course describes risk assessment and risk management, as well as adverse event reporting and premature discontinuation of clinical studies. Official guidance on GCP from the U.S. Food and Drug Administration (FDA) is emphasized as well as operational imperatives of GCP.

 

CLRA 6175 Biostatistics (3 sem. cr.)
This course addresses the application and interpretation of biostatistics in clinical research, including descriptive methodologies, commonly used statistical tests, confidence intervals, statistical inference and probability, analysis of variance, and considerations in powering a study. Basic concepts of data collection and analysis are presented using a statistical computer package such as SPSS. Development of the Statistical Analysis Plan (SAP), preparation of the statistical report, and integration in the Clinical Study Report (CSR) are also addressed.

 

CLRA 6190 Information and Data Management (3 sem. cr.) 
This course examines the importance of information systems and information technology in increasing efficiencies in the management of clinical research data. The application of legal and ethical principles are considered, with attention to the development of a data collection and management plan that promotes information archiving and access as well as edit and query management. Issues of confidentiality and the security of information systems are addressed. The course also examines emerging technology that facilitates the capture and analysis of clinical study results, such as electronic data capture (EDC) and electronic case reporting forms (eCRF).

 

CLRA 6205 Product Development in the Pharmaceutical, Biotechnology, and Medical Device Industries (3 sem. cr.)
This course examines current trends and issues in the pharmaceutical, biotechnology, and medical device industries with a focus on how the commercial enterprise utilizes clinical research to bring products to market through the clinical development and regulatory process. Topics include the process by which discoveries become new drugs or medical devices, the pre-clinical process, and the development of the clinical research plan. Consideration is given to new drug and medical device applications, pre-market approvals, marketing authorizations, and post-marketing surveillance. Topics include pharmacogenomics, pharmacoepidemiology, recent safety concerns of regulators, globalization, the politics of drug pricing and healthcare reimbursement, product life-cycle management, outsourcing of studies to developing countries, patent strategies, and accelerated approval of medications. Case studies representing several therapeutic categories are analyzed from business, medical, scientific, ethical, regulatory, and biomedical engineering perspectives.

 

CLRA 6220 Health Economics and Financial Management in Clinical Research Administration (3 sem. cr.)  
This course provides the foundations for economic evaluation and financial management in clinical research administration, with a focus on the development, analysis, and communication of economic and financial data in the context of clinical research. Special attention is given to health economic issues in the competitive global marketplace, such as resource scarcity and choice in the clinical research environment, cost/benefit considerations in study design and in evaluation of the clinical intervention, opportunity costs, quality of life considerations, valuation of research outcomes, and case studies from the National Institute of Clinical Excellence (NICE). In addition, the course considers financial management aspects of clinical research, including estimating the full cost of a clinical protocol, deciding whether to outsource, calculating direct clinical costs versus research administrative costs and institutional overhead, and developing and negotiating clinical trial budgets and payment terms with sponsors.

 

CLRA 6235 Epidemiology (3 sem. cr.) 
This course provides an epidemiological approach to the study of incidence, prevalence, and etiology of disease and patterns of injury in populations, as well as the efficacy and effectiveness of prevention and intervention strategies to be considered in clinical trials. Key sources of data for epidemiological purposes are identified. Students learn to calculate basic epidemiological measures and to draw appropriate inferences from epidemiological data and reports.

 

CLRA 6550 Practicum (3 sem. cr.)
The practicum provides an opportunity for students to apply and integrate in a clinical research setting the knowledge and skills they have acquired throughout the M.S. degree program in Clinical Research Administration and further develop key professional competencies. This 200-hour field experience is aligned with students’ academic and professional goals and proceeds under the supervision of a faculty member. It can occur at a clinical site where a research study is being conducted or with a research sponsor where a study is being planned or facilitated. Supervision by an on-site preceptor involved in the planning or conduct of a clinical research study is a critical component of the practicum. Students participate in an accompanying online seminar course and begin development of a professional portfolio based on assigned professional development activities, including a journal of interactions and interviews with clinical research administrators, an assessment of the research culture, and the identification of key management challenges in research administration. Ongoing monitoring and evaluation of student performance is provided by the on-site supervisor and the course instructor.

 

CLRA 6560 Capstone (3 sem. cr.)
The capstone is a continuation of the practicum and provides an opportunity for students to complete the number of hours required for their practicum in Clinical Research Administration, and to synthesize the practicum experience and the accompanying learning. Students also complete their professional portfolios based on their practicum experience as well as a substantive written paper or project in clinical research administration.