Graduate Diploma in Clinical Research

Identifying the most appropriate study design is important for generating the best evidence to answer a clinical research question. A well-designed study will clearly identify a range of variables including the participant population, the intervention or exposure of interest and the outcomes to be investigated and how data will be collected. Understanding the various indications for different study designs is important for not only devising a new study but also for critically reviewing published studies.

This subject will provide students with an in-depth understanding of the principles and application of a variety of study designs in a clinical/medical setting. Key areas that will be covered include:

1. examining the range of quantitative, qualitative and mixed-methods approaches such as

• experimental and quasi-experimental, cohort, cross-sectional and single-subject designs;
• participant observation, in-depth interviews, case-studies, focus groups and artefact analysis designs;
• screening, preventive and genetic/biomarker trials
• construction and administration of surveys and questionnaires and;
• the use of clinical bioinformatics, e-health and large population datasets.

2. strategies for matching study aims/objectives with selection of an appropriate study design
3. exploring sources of bias in research such as randomization, allocation, concealment and blinding and their relationship to the principles of internal and external validity
4. using published reporting guidelines (eg CONSORT statement) to aid in the design and reporting of a study
5. participant recruitment/retention/attrition, outcome measure selection and the application of power calculations
6. the principles of drug evaluation and regulation

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It is critically important that you understand your responsibilities as a clinical researcher prior to undertaking any clinical research. These responsibilities originate from the very fundamentals – What is research? Why do we do it? How does it work? In this subject, we will discover the key responsibilities that apply to clinical research. Ensuring that clinical research is conducted ethically, as well as responsibly, is also very important. This importance goes beyond ‘simple’ compliance.

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Data analysis methods are an integral part of modern clinical research. They are powerful techniques that enable researchers to draw meaningful conclusions from data collected through observation, survey, or experimentation.

However, data analysis is a huge discipline with different paradigms, schools of thought and alternative methodologies. Therefore consideration of the appropriate methods used must be undertaken when designing a study and selecting variables and groups.

This subject introduces students to the basic principles of qualitative and quantitative data analysis techniques. It will provide a functional grounding in the theoretical concepts behind each type of analysis, as well as exploration of the interpretation of data and the difference, where applicable, between clinical vs statistical significance.

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Medical research studies can be split into five distinct phases—conception, design, execution, analysis, and publication/reporting. The quality of a study is highly dependent on the selection of a proper study design and this in turn is determined by the research question to be answered.

This subject will introduce participants to the principles of research within a clinical (ie health) setting, in particular:

• turning an idea into a research question that is measurable and evaluable
• examine different study designs used in clinical/medical research
• selecting a study design appropriate to answering the research question
• refining a research question by examining the current literature through the construction of a 'literature review' of published scientific studies
• assessing the strengths, weakness and biases of qualitative and quantitative study designs commonly encountered in the medical literature
• literature searching and critical appraisal of published scientific

This subject provides individuals from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a biomedical science-based background with a conceptual framework in research which is undertaken in clinical and medical settings. This subject serves as a basis for advanced study in the Graduate Certificate in Clinical Research, the Graduate Diploma in Clinical Research and the Master of Clinical Research.

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This subject examines the processes involved in planning a clinical research project from the research proposal development stage, to project management, implementation and research translation. This subject will introduce learners to different strategies for implementing a clinical research project and provides the foundational knowledge required for developing an effective clinical research program.

Intensive Teaching Period 1 (3 days):
• The development of clinical research proposal/grant
• Examination of potential regulatory requirements and ethical, legal and compliance issues.
• Construction of a business plan and budget for clinical research projects
Intensive Teaching Period 2 (3 days):
• Managing research projects and teams
• Intellectual property law: Legal considerations to translating new research findings
Intensive Teaching Period 3 (3 days):
• Explore the principles of knowledge translation and strategies for dissemination, engaging policy and decision makers and clinical guideline development.
• Evaluation strategies to determine effectiveness of a research translation strategy

This subject builds on the knowledge and skills acquired in the Graduate Certificate in Clinical Research, and builds towards the knowledge required for more detailed study in the Master of Clinical Research.

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In this subject students will have the opportunity to undertake a small clinical research investigation in an area of clinical interest. In consultation with a research supervisor and/or the course coordinator, participants will formulate a research question and undertake a systematic or literature review to evaluate the published evidence to synthesize an answer to their research question. This subject will provide participants with the practical knowledge required to plan an evidence based clinical research project with consideration given to the process and requirements of ethics approval.

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Clinical trials are designed to test new methods of screening, prevention, diagnosis and treatment of disease and are essential to discovering whether new healthcare interventions improve outcomes for patients. This subject will provide students a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials, in particular the randomized controlled trial (RCT), and will build on the concepts introduced at the graduate certificate level. Fundamental concepts associated with the design, implementation and analysis of RCTs will be explored including selecting, recruiting and consenting study subjects, determination of study duration, comparing multiple groups and/or endpoints, designing randomisation protocols, study monitoring, quality assurance and early termination.

Delivery will be across three intensive teaching periods:

Intensive Teaching Period 1 (3 days)

Trial Design
Randomization, Blinding and Allocation
Outcome Selection

Intensive Teaching Period 2 (3 days)

Good Clinical Practice
Quality Assurance & Regulatory Processes
Study Management
Informed Consent

Intensive Teaching Period 3 (3 days)

Stakeholder Involvement
Compliance and Follow-Up
Data Storage, Management and Analysis
Clinical Trials in Rural/Remote & Vulnerable Populations

This subject provides individuals from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a biomedical science-based background with a conceptual framework in design, development and conduct of RCTs. This subject serves as a basis for advanced study in the Master of Clinical Research.

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Nearly 40% of healthcare costs can be attributed to wastage and harm. At the same time, digital health and informatics is generating rich and valuable data that can be used to generate insights and improve the quality of care, enhance patient-centred care, as well as dramatically increase value-based care. While, on average, it takes 17 years for research to translate and have impact in the clinical setting, the Learning Health System framework allows for immediate real-time interrogation of data and implementation of knowledge gained in rapid quality improvement cycles, to ultimately improve patient outcomes.

This subject will enable students to simulate and reflect on a Learning Healthcare System approach to a health service digital transformation project; to use digital patient data to gain new knowledge about a problem; to use this knowledge to inform a digital innovation in practice; and to use the ensuing practice-based evidence to guide digital health management decisions. These concepts will be taught through the lens of a real-world digital health intervention case study and the toolkit approach provides a framework to apply to the learners’ workplace endeavours.

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Healthcare is information intensive. Health data are generated, shared, consumed, and stored in a variety of partially overlapping complex networks. Healthcare lags behind many other sectors, despite efforts to use digital technologies to shape and improve health data and information processes since the middle of the 20th Century. The need for digital transformation of health is driven by socio-economic concerns (making healthcare more accessible and affordable) and patient safety (reducing medical errors, and redundant and ineffective interventions).

This subject introduces the background, current state, and future opportunities of digital health. It provides a basic understanding of health and disease and how individuals experience both. It explores the nature of biomedical data, information, and knowledge - and how digital technologies are shaping the way these are used. Digital health technologies are examined from ethical, historical, technological, and psycho-social perspectives, considering positive and negative impacts.

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The power of data analytics and artificial intelligence (AI) is being applied in health care to inform and redesign processes that improve the quality of care, enhance patient-centred care, and increase value-based care. This subject explores the strategic integration of data insights to drive this transformation in health care organisations. Participants will learn fundamental principles, methodologies, and applications of data analytics and AI in the context of data-driven decision-making in health care.

This subject will enable students to reflect on the data science foundations, practical tools and applications, human and organisational factors, governance and implementation of a health service digital transformation project. Students will understand how to effectively use digital patient data to accurately define problems and develop answerable questions. These concepts will be taught through the lens of a real-world digital health intervention case studies, and students will develop a pitch for their dream data project, culminating in students critically appraising a data process at their organisation.

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The healthcare system requires leaders, and many clinicians anticipate taking on leadership positions, or find themselves in leadership roles, without any formal education in leadership. This can have negative consequences for the leader, colleagues, patients and healthcare organisations. The purpose of this subject is to provide clinical leaders (and aspiring leaders) with knowledge of leadership practices and the opportunity to implement this learning and acquire new skills. Subject content will be grounded in evidence-based knowledge produced by leadership scholars and practiced by leaders within healthcare organisations.

Topics covered will include:

• Styles of effective clinical leadership
• Leading successful and productive teams
• Conflict resolution and difficult conversations
• Emotional intelligence
• Ethical issues in clinical leadership
• Coaching and developing others

Teaching/learning formats include:

• Interactive facilitator presentations
• Asynchronous learning via Canvas (videos, text, reflection and discussions)
• Case studies
• Group exercises
• Small team discussions of participant leadership challenges
• Participant presentations
• Guest speakers: senior clinical leaders who will share their leadership challenges and solutions

The informal exchange of insights and experiences among participants is a key aspect of learning.

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Today's healthcare system is multifaceted, complicated and often resistant to change. This subject will examine strategies for leading change in clinical settings and healthcare organisations. Participants will learn how to build and lead change initiatives, as well as to access resources, negotiate with others and effectively deal with obstacles as they implement their innovative programs.

Topics covered will include:

• Developing and implementing change initiatives
• Leveraging funding within the healthcare system
• Negotiating to get what is needed from others
• Anticipating and overcoming obstacles to change

Teaching/learning formats include:

• Interactive facilitator presentations
• Asynchronous learning via Canvas (videos, text, reflection and discussions)
• Case studies
• Group exercises
• Small team discussions of participant leadership challenges
• Participant presentations
• Guest speakers: senior clinical leaders who will share their leadership challenges and solutions

The informal exchange of insights and experiences among participants is a key aspect of learning.

View detailed information in the Handbook