HLTH 5812
Clinical Trials 1: Introduction
Fundamentals of trials of health products and different phases and types of clinical trials. Investigator vs. sponsor-initiated trials, different regulatory agencies, the use of randomization, blinding, registration regulatory requirements, rigorous documentation, and common trials.
2026
Topics
- class suspension for fall, winter breaks, and statutory holidays.
- Course level learning outcomes
- within a health-product development program.
- Translate a clinical question into the basic architecture of a trial: population, intervention
- comparator, outcomes, timing, and design.
- Apply foundational design concepts - including randomization, allocation concealment
- Evaluate participant eligibility, recruitment, representativeness, outcome selection, follow-up
- and common threats to interpretability.
- Differentiate the roles and accountabilities of sponsors, investigators, institutions
- CROs/service providers, ethics boards, and regulators.
- Explain foundational ethics, informed-consent, GCP, and Canadian clinical-trial regulatory
- protocol and trial reporting.
- Read a protocol, registry entry, and published trial critically and communicate a proportionate
- Core reference set
- every week.
- 26. Link
Readings
- processes, including information about the Academic Consideration Policy for Students in Medical and Other Extenuating Circumstances, are outlined on the Academic Accommodations website
Sources
- Course catalogue ↗2026–2027
- HLTH 5812 F2026_forposting ↗2026