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Conduct of Clinical Research Trials G (7514.3)

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

Availability

    Syllabus

    This unit provides students with an understanding of the processes involved in the implementation of clinical trials research. It is aimed at CRA level or equivalent. It is appropriate for those wishing to refresh existing skills or receive an introduction to clinical trials research process. Topics are presented in line with Australian and International laws, regulations and guidelines including The Declaration of Helsinki, GCRP, ICH GCP, the Belmont Report, and the National Statement on Ethical Conduct in Research Involving Humans (1999). Content includes: general issues in data collection; recruitment and retention of trial participants; statistics; Standard Operating Procedures (SOPs); role of the CRA in adverse events and serious adverse events(SAEs); general issues to consider in the auditing and monitoring process.

    Learning Outcomes

    DESCRIPTION:

    1. accurately identify problems and inaccuracies in the clinical trials implementation process

    2. provide accurate and appropriate solutions to these problems and inaccuracies

    3. demonstrate knowledge of what to do and who to approach when difficulties emerge in the day to day implementation of a clinical trial

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

    5. know the principles that relate to the publishing of trial data and results in various settings

    6. apply and discuss conflict resolution strategies to selected clinical trial scenarios

    7. mount and defend an argument

    8. demonstrate an appropriate level of written communication skills

    Contact Hours

    Two hour lecture equivalent a week

    Prerequisites

    Design of Clinical Research Trials G

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