Graduate Certificate 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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