
Certified Clinical Research Associate Course Descriptions
276-001 Clinical Trial Research Coordinator (3 units) Register for this class.
This course will prepare you to assume the duties of managing and organizing a clinical trial. The nuts and bolts of running a trial, getting ready for a pharmaceutical company audit, understanding the standards and regulations that affect the conduct clinical trials in Canada and a basic understanding of ethical principles and data organization are covered in a series of workshops.
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276-002 Research Ethics and Regulatory Affairs (3 units) Register for this class.
This course will provide an understanding of the ethical guidelines, issues and challenges of conducting research on human subjects. Special rights and concerns of participants will be explored. Students will understand and learn how to cope with conflicts of interest and will discuss challenging case scenarios like genetic testing, limits of confidentiality and the meaning of minimal risk. Health care legislation, guidelines, regulatory and research contractual issues will be covered in the context of protecting all research parties and explaining their rights and liabilities. The format will be a series of lectures and small group workshops using a problem-based approach to learning.
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276-003 Clinical Trial Methodologies in Practice (3 units) Register for this class.
This course will be offered in two parts: A series of workshops explaining clinical research designs, clinical outcomes and measurement tools, with real life illustrations, including a module on consent forms, and sessions on compiling a protocol and developing the ideal questionnaire.
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276-004 Statistics, Databases, and the Internet in Clinical Research (3 units)
This course is designed to familiarize you with basic biostatistical concepts and methods required in the development and implementation of a clinical trial and the analysis and interpretation of data. New and improved hardware and software packages are constantly being churned out, making it harder to choose the appropriate one for your purposes. Setting up databases, maintaining and manipulating them as well as using the Internet effectively to conduct searches and collect relevant information will be taught in a module format.
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276-005 Critical Analysis and Advancement of Writing & Communication Skills (3 units)
A practical lecture and workshop series examining the optimal strategies to improve writing and communication skills. The course focuses on enhancing your interpersonal communication skills by developing active listening and interviewing strategies. Understanding of organizational dynamics, conflict resolution and negotiation strategies in the context of dealing with internal and external parties involved in a clinical trial will be discussed in a workshop style. Students will develop their presentation skills by participating in class presentations. The basic grant-writing skills will be taught with hands-on sessions using real protocols. A critical analysis sensitivity will be developed by discussing the critical components of publications in general and how to best present your data.
