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.
Clinical Research
Program Learning Outcomes
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, biopharmaceuticals 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, biopharmaceutical and/or natural health product that complies with industry and government standards and protocols.