This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaption of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.

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.

This unit of study will examine and critique established and emerging ways of researching nursing and health care through discussion of the philosophical and theoretical origins of the research traditions and knowledge generation in nursing 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.

In this unit of study, students will extend their professional knowledge and skills through further critical analysis of issues that affect the management, conduct and practice of clinical trials. The unit provides a framework for students to explore specific, contemporary workplace situations relevant to clinical trials practice: it is a bridge to professional practice. These situations may range from the development of a proposal for a new clinical trial, focus more specifically on a particular aspect of trial conduct, or on the development of a plan for implementation and management of a clinical trial. In this work, students will be supported to develop their expertise while working within an ethical and regulatory framework. Through the development of a learning contract, the capstone objectives and outcomes will be tailored to each student's individual learning needs in close negotiation with the course coordinator.