This course identify abnormal physiologic state of disease topics: basic concepts of disease processes, muscleskeletal disorder, skin disorder, lymphatic disorder, cardiovascular disorder, eye disorder, respiratory disorder, endocrine disorder, digestive disorder, urinary disorder and the neurologic disorder.
Through past/current examples, lectures and discussion groups, the student will learn the principles and concepts in determining the proper approach to solving ethical dilemmas one might encounter in research.
Introduction to the principles of pharmacology including pharmacokinetics and dose response relationships. DNA. Major classes of therapeutic agents are covered with attention to their mechanisms of action. Addresses issues of concern in drug development and the biological bases for population variability in drug response.
An examination of the distribution and dynamics of human health problems on the community level and exploration of the scientific investigations used to determine circumstances under which diseases occur or health prevails.
This course is designed to provide students with fundamentals cognitive knowledge of interviewing, formulating write-ups and physical assessment techniques. Techniques of screening, pre-operative physical examinations, lectures and demonstrations.
A study of the entry, distribution, biotransformation, and mechanism of action of chemical agents harmful to the body.
Students receive a baseline understanding of the epidemiology and pathophysiology of cancer; discuss the cancer types and treatment modalities, identify common cancer complications, discuss supportive care issues and identify key health care professionals involved in cancer care/research.
A study of effective management of financial resources in health care facilities. Focuses on the basic concepts of cost accounting, financial reporting, reimbursement, budgeting, financial controls and strategic financial planning.
This course introduces students to the history of the FDA and drug development. It describes the science of biotechnology, medical devices and bio-pharmaceuticals, taking the student through the history of the industry and covers the basic science of DNA and its functions, immunology, proteins and their purification, and fundamental techniques used in the research and development of biotechnological and bio-pharmaceutical products. Includes an overview of drug approval by the FDA. Introduces students also to the pharmaceutical industry, the bio-pharmaceutical industry and the drug development process. Drug development from chemical synthesis to phases 1-4 is discussed. The regulatory requirements of the FDA are reviewed along with the content of the investigational new drug application (IND), the new drug application (NDA), and the marketing authorization application (international). The role of the investigator, coordinator, sponsor, clinical research associate and monitor are discussed. Individuals are exposed to the skills necessary to function as a successful study monitor.
Addresses the regulatory requirements necessary to take a product from basic research through clinical trials. Topics include pre-clinical safety and testing requirements, IND components, manufacturing and products quality regulations and guidelines, and the regulatory requirements for clinical trials. The focus is on therapeutics, diagnostic agents and devices. The development of these components is discussed from a regulatory standpoint.o.
Details FDA guidelines for the development and commercialization of drugs, devices, and biologics. The documents and forms required for the entire process are covered, as well as international harmonization regulatory concerns and establishment license applications (ELA).*Pre-requisite: MSCR 662 Regulatory & Compliance Issues
A study of the medical product development process, regulatory requirements for medical devices, their quality systems.
Risk and causality. Comparing therapies: The randomized controlled clinical trial, normal (gaussian) distribution, confidence intervals, hypothesis testing, tests of statistical significance-Chi-square procedures, quantification of risks, Tests of statistical significance: Regression and correlation paired and pooled tests, analysis of variance. Lecture and laboratory consists of training in the following software: SPSS, SAS and if time permits, Minitab statistical software.*Pre-requisite: MSCR 668
Covers the history and current methodologies used in the design and conduct of clinical trials. Topics include sample selection; data forms and management; patient recruitment, enrollment, and compliance; and measures of cost containment and effectiveness. The role again of the varied individuals who accomplish the success of clinical trials, i. e. the pi, coordinator, CRA, Sponsor, Monitor. The need and value of integrity within work without compromise. The importance of being self-motivated and willing to work on one’s own.
An overview of the development contents and process of the clinical research study. Topics include: protocols, case report forms, investigator brochures, informed consent, institutional review boards and statement of investigator form 1572.
Expands upon the processes of study management, topics include source documents verification, visit types, drug accountability, adverse events, laboratory and supplies. *Pre-requisite: MSCR 674 Clinical Study Administration I
This capstone experience utilizes the background materials presented before to develop concepts of negotiation, presentations, time management, travel smarts as they pertain to the role of clinical research associates. In addition, record keeping, data management, and data correction techniques are presented.
Designed to give clinical research associates and coordinators the skills necessary to manage large and small projects such as research protocols and studies. Students develop, manage, and present a project using the computer, utilizing techniques such as charts, critical paths, written reports and visual presentations. Projects are tracked and managed using comparisons of initial baselines of forecasts with ongoing and final results.
Introduces the regulatory responsibilities of the sponsors, monitors and investigators conducting clinical trials. Practical information and exercises designed for the clinical trial professional on procedures for ensuring GCP compliance from an industry perspective. Topics include; identifying and selecting qualified investigators, obtaining ethical approval to enroll patients and initiating site visits successfully. In addition, covers issues related to collecting required regulatory documentation, verifying high quality data. Maintaining study materials, accountability, and reporting serious adverse events. Group discussions and guest speakers help students learn the practical skills used in the field. The need for and importance of standard operating procedures.
Audits that reference particular guidelines in the CFR.
Those issues which make up the business development side of research or establishing an investigational group. Inclusive of the setting up of the office and the recruitment of patients. How to arrange investigator meetings. Financial cost issues and the managing and tracking of expenditures, etc.
The forms, their correct usage and flow in the clinical trial process. What happens at closeout visits and reconciliation of GCP materials.
Students examine clinical investigations through analysis of two randomized clinical trials.
To supply students with the necessary and basic tools needed for medical/ technical writing of reports, proposals, grants and other documentation as part of clinical research.
Finding and developing proposals for public and private funds, writing corporate proposals, writing government proposals, editing techniques, search engines. Grant reviews and funding decisions. Students will write, and submit an actual grant by the end of the class. Oral presentation of the grant proposal is also required of each student.
MSCR 697 and MSCR 698: Preceptorship-Clinical Research Practicum* (16 credit units/ 480 Externship Hours)
The preceptorship is a three–month, full time experience, which occurs both in either a clinical setting or clinical research organizational setting. Students will interact with clinical research associates, clinical research coordinators, and clinical scientists in a workplace setting to develop and polish clinical research coordinating and monitoring skills. *Pre-requisite:Completed all required coursework in the catalog.
With the guidance of a faculty committee, each student begins task of writing the thesis. Students meet with their individual committee to begin the thesis project. Completion of this activity helps to develop the students’ abilities for critical review of literature, understanding key health care issues and communicating with precision, cogency and force. *Pre-requisite: Completion of all didactic coursework and certification for candidacy must be accomplished during this term.
Continuing with the guidance of a faculty committee, each student continues the process of writing the thesis. Completion of this term, allows the students to continue directed work towards the completion of the thesis.
Continuing with the guidance of a faculty committee, each student continues the process of writing a thesis. With the completion of the thesis, and the appropriate public defense of the thesis, and the certification by the duly appointed committee, the student may make application for graduation.