Clinical Research

Course Code: ANAT 5000

This course is designed to cover the structure and function of the human body with special emphasis on physiological concepts. Students will become familiar with the nervous, endocrine, cardiovascular, respiratory, digestive, urinary and reproduction systems, as well as fluid/electrolyte and acid/base balance.

Course Code: CLIN 5000

This course is designed to orient the student to the drug development process and the clinical research function within the corporate and regulatory context, from both Canadian and international perspectives. (Drug development is used as a model, however the same principles are applicable to devices and biologics, and specific differences will be highlighted.)

Course Code: CLIN 5002

This course is designed to provide a framework for understanding the standards and regulations that affect the conduct of clinical trials. The course will starts with a historical overview of such documents as the Nuremberg Code, the Belmont Report and The Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, which will include GCP, reporting of adverse reactions and trials in special populations. Additionally, such topics as the Tri-Council Policy Statement, the Food and Drugs Act, the SAP program and privacy legislation will be discussed.

Course Code: CLIN 5005

This course focuses on the clinical research context for interpersonal transactions. Students will enhance their interpersonal communication skills by developing active listening and interviewing skills. Understanding of personal effectiveness, organizational and conflict resolution strategies will assist students. In developing skills in the use of collaborative and problem-solving approaches in professional relationships. An understanding of personal strengths and weaknesses will help the student to set up personal goals.

Course Code: CLIN 5009

This course will provide detailed knowledge on the application and relevance of laboratory values in clinical research. The students will learn about laboratory methods, about false positive and false negative outcomes and their interpretations. The emphasis will be on interpretation of the results in relation to different disease states.

Course Code: CLIN 5010

This course is designed to enhance the writing, editing, and comprehension strategies of students for whom writing is an important function in their employment. The goal of this course is to provide some of the tools that students need to continue improving their own writing. Students will focus on writing skills, including grammar elements and spelling, and will practice editing, organizing, and summarizing scientific documents, as well as becoming familiar with different types of internal and external business communications.

Course Code: CLIN 5013

This course is designed to provide students with the basic concept in biotechnology with a focus on medical biotechnology. The course comprises of 14 lectures that cover a broad range of topics on products and technologies used for human health or the health-care system. Central to the study of biotechnology is an understanding of the basic concepts in molecular genetics, protein chemistry, microbiology and immunology. The students will learn about recombinant DNA technology and genomics, which has application in drug development, pharmacogenomics, DNA-based diagnosis of genetic diseases and in human gene therapy. Also, students will learn the concepts underlying the innate and adaptive immunity, which has application in the development of vaccines for infectious diseases, in oncology, and transplantation. Some lectures will review current medical products and applications of biotechnology and will present a brief background of the growth and future potential of biotechnology products. Current regulatory framework governing this industry in different countries will be explored by visiting related websites.

Course Code: CLIN 5014

This course is designed to introduce the students to the fundamentals of pharmacology. It will focus on the relationship between a drugs mechanism of action at the molecular level and its effect on the patient. Course material will balance both basic and clinical aspects of drug action, with the goal of providing the students with a fundamental understanding of the field of pharmacology. The general principles of pharmacokinetics and pharmacodynamics will be introduced and students will examine various body systems such as the anatomic and central nervous systems, and the cardiovascular, respiratory, renal, blood, endocrine and gastrointestinal systems. Additionally, anti-infective chemotherapeutic agents and various mediators of tissue responses will be discussed. A prior knowledge of basic physiology, anatomy and biochemistry is recommended to fully appreciate the topics discussed in this course.

Course Code: PATH 5000

This intense course will introduce students to the subject of pathophysiology. The students will study about different diseases, their etiology, epidemiology, symptoms, and other abnormalities associated with these diseases. The emphasis will be on diagnosis in relation to endpoints used in clinical research.

Course Code: CLIN 5503

This course is designed to outline the various stages of clinical research as they relate to the investigative site. The course will review the progress of a study from an investigator's as well as a sponsor's perspective and highlight the milestones reached throughout the study. Students will learn the management and organizational aspects of site monitoring combined with the quality control measures that ensure the collection of adequate data.

Course Code: CLIN 5504

This course will provide an introduction to the biostatistical concepts and methods required in the development of a clinical trial and the analysis and interpretation of clinical trial data. This course will also provide an overview of methods available for the collection of clinical trial data, such as paper-based methods, fax-based methods, and remote data-entry methods.

Course Code: CLIN 5506

This course is designed to ensure that students are aware of the practices, issues and concerns with regard to the handling of investigational materials used in clinical trials. Students will be introduced to common practices and guidelines for the safe and effective handling of these materials.

Course Code: CLIN 5507

This course will guide student through the requirements of effective protocol and report form development. Students will understand the elements of effective protocols. Case studies will be examined to highlight practical issues and concerns.

Course Code: CLIN 5508

This course will provide students with an opportunity to explore some of the special considerations and techniques applicable to clinical trials in various therapeutic areas and disease states. Guest speakers with a focus on particular areas of research will outline the current status of drug development and treatment modalities in their respective areas. The course will include a team project where students will select, investigate and report on current research activity and methodological issues in a therapeutic area of interest.

Course Code: CLIN 5511

This course has been designed to introduce students to the principles and practice of project management as a common approach to structuring work in the pharmaceutical and biotechnology industries. The course will emphasize skills, attitudes and values necessary to be a contributor in the workplace of both big pharma and smaller Canadian biotech companies, as well as in hospital setting.

Course Code: CLIN 5512

This course will focus on medical devices with all relevant aspects starting from definition of medical device to mechanism of surveillance of marketed medical devices. The students will learn a process of applying for licenses for medical devices, obtaining certifications, submitting annual notifications, etc. Specific regulatory requirements for medical devices manufactured in Canada, US, European Union countries and others will be discussed. Additionally students will review Canadian Medical Devices Conformity Assessment System.

Course Code: CLIN 5515

The students are expected to find and complete an internship in the clinical research area in the health care industry such as pharmaceutical, medical device or biotechnology companies; hospitals; government, etc. The internship will allow you to apply in a real-world work setting, the clinical research skills and knowledge acquired during the first two semesters.

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