Introduction to Clinical Trials
About This Course
This five-day course equips healthcare professionals with the knowledge and practical skills to establish and implement clinical trials that are underpinned by robust clinical governance. Covering the full lifecycle of Phase III clinical trials—from study design to trial closure—the course emphasises regulatory compliance, ethical oversight, quality management, and risk control to ensure safe, accountable, and high-quality research practice aligned with organisational and national regulatory frameworks.
Participants will learn to develop scientifically robust and ethically sound study protocols, define research questions using the PICO framework, determine appropriate sample sizes, and interpret treatment effects. Strong emphasis is placed on governance responsibilities, including essential documentation, safety reporting, monitoring, audit readiness, protocol amendments, and quality assurance processes.
Through applied learning, participants will strengthen their ability to manage trial operations in accordance with Good Clinical Practice (GCP), minimise bias through appropriate randomisation and outcome measures, and ensure data integrity and patient safety. The course also provides guidance on grant preparation and an introduction to innovative designs such as platform trials.
What You'll Learn
Equip participants with foundational knowledge of clinical trial design and governance.
Develop competencies in implementing quality assurance, risk management, and bias control strategies.
Enhance understanding of regulatory requirements, ethical standards, monitoring, and audit processes.
Build capability in managing essential trial documentation, safety reporting, and compliance.
Support the preparation of research funding applications, incorporating tasks associated with clinical trial governance
Provide an overview of trial closure procedures and accountability requirements.
Introduce emerging trial methodologies, including platform trials
Entry Requirements
Education Level
Applicants should possess at least a basic degree from a recognised institution.
Relevant Work Experience
Applicants are recommended to have relevant clinical practice, research experience, or involvement in clinical studies.
Language and Literacy Proficiency
Proficient in English