Program Learning Outcomes

This Seneca program has been validated by the Credential Validation Service as an Ontario College Credential as required by the Ministry of Training, Colleges and Universities.

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, biopharmaceutials 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, biopharmaceutial and/or natural health product that complies with industry and government standards and protocols.

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