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Foundations of Clinical Research: Understand the history, terminology, and the critical phases (Phase I-IV) of drug development.
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Ethics & Regulatory Framework: Master the ICH-GCP guidelines, Informed Consent processes, and the role of Institutional Review Boards (IRB/IEC).
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Trial Documentation & Design: Learn how to manage essential documents, including the Protocol, Investigator’s Brochure, and Case Report Forms (CRFs).
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Clinical Data Management: Introduction to how trial data is captured, cleaned, and analyzed.
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Safety & Pharmacovigilance: Understanding Adverse Events (AEs) and the importance of participant safety reporting.