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Design of Clinical Research Trials G (7513.3)

Level: Graduate Level
Credit Points: 3
HECS Bands:

Band 2 2021 (Commenced After 1 Jan 2021) Band 3 2013-2020 (Expires 31 Dec 2020) Band 3 2021 (Commenced Before 1 Jan 2021)

Faculty: Faculty of Health
Discipline: Discipline of Pharmacy



    This unit provides an understanding of principles that apply to the clinical trials process. It is aimed at the CRA level or equivalent and is appropriate for those wishing to refresh existing skills or gain an introduction to the principles involved in the design of clinical trials research. The content includes: outline of the history of development of clinical trials research process; introduction to relevant legal and ethical guidelines governing clinical trials design; hypothesis generation and clinical trials; introduction to the four phases of clinical trials research; the design principles involved; beginning level statistical issues; single and multi-centre trials.

    Learning Outcomes


    1. Accurately apply the principles as outlined in the above syllabus to selected case scenarios and/or a trial protocol

    2. Identify any problems and inaccuracies in these same scenarios and provide accurate and appropriate solutions to them

    3. Accurately apply statistical information for a clinical trial to selected cases to the level taught in the unit

    4. Discuss the general principles of clinical trials research and their relationship to the design process as well as to the regulatory and ethical principles and guidelines

    5. Demonstrate an appropriate level of written communication skills as required for a Clinical Research Associate

    Contact Hours

    Two hour lecture equivalent a week


    Course entry requirements

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