CRA 101 Clinical Trial Research Coordinator (3 Units)

Formerly 276-001
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 conducting clinical trials in Canada, and a basic understanding of ethical principles and data organization are covered. The practical component consists of two half-day preceptorships with experienced clinical trial researchers in different clinical areas.

CRA 102 Research Ethics & Regulatory Affairs (3 Units)

Formerly 276-002
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, and 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.

CRA 103 Clinical Trial Methodologies in Practice (3 Units)

Formerly 276-003
A series of workshops explains 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. Study management will be demonstrated by reviewing a mock clinical trial protocol review and auditing by a pharmaceutical company representative.

Prerequisite: It is suggested that this course be taken last.

CRA 104 Statistics, Databases & the Internet in Clinical Research (3 Units)

Formerly 276-004
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.

CRA 105 Critical Analysis & Advancement of Writing & Communication Skills (3 Units)

Formerly 276-005
This practical lecture and workshop series examines 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. 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. 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.