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 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.