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Unit of study_
CLTR5009: Operational Principles of Clinical Trials
2024 unit information
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 the costs 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.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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| Academic unit | NHMRC Clinical Trials Centre |
| Credit points | 6 |
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Prerequisites:
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CLTR5001 |
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Corequisites:
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None |
| Prohibitions:
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NURS5068 |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. • Define a clinical trial through; describing the reason/s for conducting a clinical trial, outlining the clinical trial lifecycle, understanding the responsibilities of key individuals and teams involved in clinical trial operation, understanding the different models of clinical trial conduct, discussing the need for clear delineation of roles and responsibilities in clinical trials
- LO2. • Understand the ethical, regulatory and legal principles that underpin clinical trials by; describing the key ethical requirements that apply to various stages of the clinical trial lifecycle, identifying the critical elements of Informed Consent and describe strategies for obtaining Informed Consent from trial participants, recognising groups of participants to whom additional ethical considerations apply, and describe these considerations, understanding the role of Research Governance in clinical trials, describe the key features and processes associated with the regulation of clinical trials in Australia, outlining the key legal considerations in clinical trials
- LO3. • Apply the principles of project management to clinical trials, with particular emphasis on: Budgeting, Project Oversight, Monitoring and reporting trial progress, Monitoring recruitment and Follow-up, Trial closure and archiving
- LO4. • Describe the importance of Quality Management in clinical trials, with particular reference to: Documentation, Audit, Monitoring. Explain the importance of quality reporting in clinical trials, and describe how quality reporting is incorporated into the preparation of the clinical study report, and dissemination of trial results via reports and publications.
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
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Modes of attendance (MoA)
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Important enrolment information
Departmental permission requirements
If you see the ‘Departmental Permission’ tag below a session, it means you need faculty or school approval to enrol. This may be because it’s an advanced unit, clinical placement, offshore unit, internship or there are limited places available.
You will be prompted to apply for departmental permission when you select this unit in Sydney Student.
Read our information on departmental permission.
