The University of Newcastle, Australia
Not currently offered
Course code



10 units


2000 level

Course handbook


This course focuses on the acquisition of skills necessary to design clinical research studies. Such skills include the development of a clinical research question/hypothesis, importance and implementation of ethical approval and informed consent, the ability to clearly define the aims, the inclusion of appropriate controls, and methods for assessing clinical research questions and the presentation of clinical research.


Not currently offered.

This Course was last offered in Semester 2 - 2020.

Learning outcomes

On successful completion of the course students will be able to:

1. Formulate a clinical research question

2. Identify the key ethical considerations for addressing clinical research questions

3. Be familiar with good clinical practice guidelines and the national statement on ethical conduct in human research

4. Identify common clinical study designs and determine which design is appropriate for a given hypothesis

5. Understand the concept of informed consent and how to gain informed consent from a potential research participant

6. Discuss various areas of clinical research including (but not limited to) Epidemiology, Health Behaviour Science, Clinical Trials (stroke, respiratory, nutraceuticals), Bioinformatics/Biomarker discovery

7. Write a brief clinical research protocol and present this for a clinical audience


1. Important elements of a good clinical research project

2. Formulating a clinical research hypothesis

3. Good clinical research design

4. Ethical design and informed consent

5. Analysis and presentation of clinical research data

Assumed knowledge

HUBS1403, HUBS1404, PHIL2420 or HUBS1422

Assessment items

Written Assignment: Written Assignment

Presentation: Oral Presentation

Formal Examination: Final Exam