ÌÇÐÄvlog¹ÙÍø

This ÌÇÐÄvlog¹ÙÍø program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Colleges, Universities, Research Excellence and Security.

As a graduate, you will be prepared to reliably demonstrate the ability to:

• Apply Health Canada and FDA regulations to clinical research.
• Explain the product development process for products such as drugs, medical devices,Ìýbiopharmaceuticals and natural health products.
• Identify the roles and responsibilities of the different positions (Principle Investigator, Clinical Research Associate, Clinical Research Monitor, Study Participant) within the clinical research process.
• Communicate professionally both orally and in writing within the clinical research environment.
• Create documentation examples that are integral to clinical research.
• Interpret data collected in clinical lab procedures.
• Describe Good Clinical Practices as they apply to different aspects of the Clinical Trial.
• Analyze the principles of quality assurance as they apply all aspects of clinical research.
• Assess the compliance of clinical trial aspects to regulatory requirements (GCP, CLP, GMP).
• Incorporate ethical practices in all stages of the clinical trial.
• Compare and summarize international regulations, clinical requirements and best practices for the clinical research process.
• Design a clinical study for a given drug, medical device,Ìýbiopharmaceutical and/or natural health product that complies with industry and government standards and protocols.