Clinical Research

Effective communication is vitally important in clinical research. Whether communicating the research results to the public, publishing in a scientific journal, explaining the risks to the study participants, or completing a regulatory compliance document, clinical research professionals engaging and recruiting within the patient community, must communicate in a clear, effective and compelling manner. In this course, the students will gain the foundational skills of communicating with a variety of stakeholders across different clinical research settings. Through hands-on projects, students will learn how to prepare different styles of written and spoken communications related to clinical research, and how to tailor the communication strategy based on the purpose and audience.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

• Hours: 1
• Credits: 0
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

Clinical Research involving humans needs to adhere to a stringent framework of regulations and practices to ensure safe and ethical treatment of participants. In this course students learn to apply the regulation on clinical trials and the principles of Good Clinical Practice (GCP) as described by the International Conference on Harmonization to various clinical research context. Students also learn the fundamentals of ethics and ethical treatment of participants, including culturally safe and appropriate health research practices.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

Accuracy and reliability of clinical documentation is of paramount importance to the success of clinical research. In this course students learn to create effective documentation management processes and gain expertise in applying guidelines to accurate and reliable documentation. In particular, students will learn to properly use REDCap, Excel, R programming and data management via the cloud to ensure proper data transfer and integrity as well as maintain strict patient privacy. Students gain expertise in preparing a variety of clinical research documents in accordance with the ALCOA (attributable, legible, contemporaneous, original and accurate) criteria.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

This course introduces the concept of Quality Assurance as it applies to clinical settings. By examining Quality Assurance theory, students learn to apply best practices in Quality Assurance to their context. Students learn to apply Standard Operating Procedures (SOP) throughout the lifecycle of a clinical trial to ensure integrity, efficiency and compliance.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

In this course, students develop the foundational concepts underpinning clinical research. Students will be exposed to the foundations of clinical research in drug, device, biologics and intervention development. Using the knowledge of clinical research foundations, the students build skills to appropriately support clinical research initiation and management to bring it to successful completion.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

Regulation plays a crucial role in protecting public safety and conducting clinical trials. In this course, students will determine the ethical, scientific, and legal aspects of the regulatory framework for conducting clinical research by analyzing and implementing the guidelines for Good Clinical Practice (GCP). In addition, students will gain an understanding of how regulatory agencies such as Health Canada, FDA, and EMA monitor and inspect clinical research around the world. Finally, using the knowledge and skills gained throughout the course, students will propose a novel clinical research project, prepare a clinical trial application, demonstrate compliance with a regulatory body, and simulate a data submission report to disseminate the clinical results of their project.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.

In this course, students build a foundational understanding of clinical laboratory processes underpinning clinical research. The course focuses on the importance of Good Laboratory Practices and regulatory framework in clinical data acquisition, recording, and reporting. During laboratory experience, students will become familiar with collecting, processing, and analyzing clinical data related to microbiology, physiology, and pharmacology. In addition, students will develop and implement Standard Operating Procedures that align with quality assurance principles and comply with applicable regulatory frameworks and best practices. The course also explores the use of artificial intelligence in data collection and verification, diagnostics, and drug development in clinical research trials.

• Hours: 42
• Credits: 3
• Pre-Requisites:
• CoRequisites:
• Estimated required text and/or learning resource costs: No cost.