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Unit of study_

Operational Principles of Clinical Trials - CLTR5009

Year - 2020

This unit of study will cover the principles of operationalizing a clinical trial. Students will acquire the knowledge needed to conduct quality studies providing research data and to comply with Australian regulatory and ethical requirements of a clinical trial. Areas covered will include single and multi-centre trials along with the roles and responsibilities of different trial personnel and committees. Clinical trial project management including thecosts of study resources and budgets, management of recruitment and follow up, and monitoring study progress will be covered, along with the ethical and legal framework governing clinical trials. This will also include aspects of ethics approval and patient consent in various patient populations. Aspects of quality assurance in clinical trials including documentation of study procedures, clinical trial audits, and study monitoring will be discussed. The development of clinical trials reports, results and publications will also be covered.

discussion groups and problem based learning

online participation (5%); 1 x online quiz (15%), 2 x 2000 word written assignments (2 x 40%)




Faculty: Medicine and Health

Semester 2 Early

03 Aug 2020

Department/School: NHMRC Clinical Trial Centre
Study Mode: Online
Census Date: 31 Aug 2020
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
More details
Unit of Study coordinator: Kate Sawkins, Rebecca Mister
HECS Band: 2
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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