This introductory program provides a foundation in clinical research, covering drug discovery, BA-BE studies, and clinical trial phases and designs.
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Learn the regulatory and ethical frameworks that govern clinical research across jurisdictions
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This course focuses on the essential documents that demonstrate regulatory compliance, data quality, and subject protection in clinical trials
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Explore the ethical protections and regulatory submission pathways that support safe, responsible clinical trials.
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Learn how clinical trial sites are identified, evaluated, activated, and managed throughout a study.
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Focused on day‑to‑day clinical site operations, this course covers participant recruitment & retention strategies, biospecimen collection and processing, sample storage documentation, and coordination with bio‑analytical laboratories.
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This course traces the flow of data from source to database lock. Learners explore source data collection, eCRF/CRF entry, validation, etc
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Learn how monitoring strategies protect data quality and participant safety
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An introduction to pharmacovigilance principles and post‑market/clinical development safety responsibilities
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This course walks through end‑of‑study activities, including site and sponsor close‑out procedures, essential document reconciliation, Clinical Study Report (CSR) preparation (ICH E3), regulatory reporting requirements, clinical trial registry submissions, electronic record compliance (21 CFR Part 11), and Canadian human research ethics (TCPS 2).
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