A fundamental understanding of clinical trials methods is critical to the role of both the clinical research nurse and professional. This unit of study will focus on clinical trial design from human phase I studies through to late phase trials. We will introduce, examine and critique clinical trial design features and concepts such as selecting the right patient population, randomisation and blinding, concepts of internal and external validity, defining study endpoints and choosing appropriate outcome measures. Students will also gain insight into how clinical trial questions are formulated from initial concept through to the development of a clinical trial protocol. Throughout this unit of study students will be exposed to a number of clinical trial design case studies, including those testing both pharmacologic and non-pharmacologic interventions.

A fundamental understanding of biological measurement and the analysis of clinical trial data is critical to the application of clinical trials methods. During this unit of study, students will have the opportunity to develop skills in simple database design and management, design patient data collection tools and instruments such as case report form (CRFs) and demonstrate an ability to review and manage data to ensure data quality and integrity. Students will also be introduced to key statistical considerations in clinical trial study design and analysis, including hypothesis testing, determining sample size, statistical power and significance and an overview of common statistical tests used in clinical trials. Students will further develop an ability to interpret and critique data and statistics from clinical trials including how this information is translated into clinical practice.

This unit of study will provide students with the knowledge and skills of translating clinical trials methods and theory into practice. Students will be introduced to principles of clinical trial project management including the management of patient recruitment and follow up, monitoring study progress, clinical trial budgeting and funding. This unit of study will also focus on the ethical and legal framework which governs clinical trials including ethics approval, informing patients, and obtaining consent in the context of clinical trials and various patient populations. A key feature of clinical trials relates to quality assurance aspects such as documentation of study procedures and clinical trial audit, consequently emphasis will be placed on the development of clinical trials reports, results and publications.

In this unit of study you will critically analyse approachs to research through examination of the philosophical and theoretical origins of the research traditions and knowledge generation in nursing and other health research. Conceptualisation of research questions, selection of research designs, governance of research and research utilisation in the clinical setting will be explored. Opportunities will be provided to engage in the research process with reference to clinically related situations.