Description
Unit 1: Introduction to Clinical Trials
This unit provides a thorough introduction to clinical trials research. You will learn about the research roadmap, the different phases of research, developing a research question, hypothesis, and objectives, and what is involved in protocol development and site selection. This unit also provides an overview of what a typical clinical trial may involve, including participant recruitment, enrolment, and study visits.
Unit 2: Clinical Trial Regulation, Roles and Responsibilities
This unit provides a brief introduction to the regulation of human research, the roles of the stakeholders involved, and the responsibilities that each stakeholder has in the lifecycle of clinical trials research.
Unit 3: Clinical Research Study Design
This unit covers primary clinical trial design elements and commonly adopted structural study designs. You will learn about their purpose, unique functions, methodologies, and the advantages and disadvantages of each, as well as other important things to consider when designing a clinical trial, such as bias.
Unit 4: Understanding Clinical Trial Results
This unit covers fundamental statistical concepts relevant to clinical trials, including key definitions and basic methods by which data generated can be summarised and analysed. You will learn about hypothesis testing and statistical significance, and the importance of correct interpretation and critical appraisal of trial results.