Outline

Overview

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

Unit code	CLTR5009
Academic unit	NHMRC Clinical Trials Centre
Credit points	6
Prohibitions ?	NURS5068
Prerequisites ?	CLTR5001
Corequisites ?	None
Assumed knowledge ?	None
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Rebecca Mister, rebecca.mister@sydney.edu.au
Lecturer(s)	Hannora Jurkovic, hannora.jurkovic@sydney.edu.au
Lecturer(s)	Rebecca Mister, rebecca.mister@sydney.edu.au
Tutor(s)	Anthony Jaworski, anthony.jaworski@sydney.edu.au

Type	Description	Weight	Due	Length
Assignment	Long answer questions 2 Written task	40%	Formal exam period Due date: 13 Nov 2023 at 23:59	2000 words
Outcomes assessed:
Participation	Online participation Participation and forum posts	5%	Multiple weeks	n/a
Outcomes assessed:
Online task	Online quiz MCQ and true/false	15%	Week 07 Due date: 11 Sep 2023 at 23:59	50 minutes
Outcomes assessed:
Assignment	Long answer questions 1 Written task	40%	Week 10 Due date: 09 Oct 2023 at 23:59	2000 words
Outcomes assessed:
= hurdle task ?

Assessment summary

This unit of study will be assessed via online participation (5%), one online quiz (15%) and two 2000 word written assignments (40% each).

Assessment 1 (online participation 5%) – To receive marks for online participation, you must respond to the discussion question per Module in Canvas. These will be posted throughout weeks 2 – 13 (1.25% per module will be awarded). A meaningful discussion posting is one that makes a valuable contribution to the group discussion. Contributions should relate to the content of the current module being studied.

Assessment 2 (online quiz 15%) – For assessment 2 you will required to complete an online quiz in Canvas.

Assessments 3 and 4 (written assignments, 40% each) - will be released in the “Assignments” tab in Canvas. You will also be required to submit (upload) your assessments in this same location. Please ensure you include your student number as part of the file name of your assignment: e.g. 123456_Assessment_3.doc. Please do not include your name in the assignment or the file name of the assignment.

Marks for assessments will be posted using the “My grades” tool in Canvas.

Please note: Assessment deadlines are important. Extensions may be granted for special circumstances. Special consideration needs to be sort from the University, done via an online application. It is the student’s responsibility to discuss arrangements with the course coordinator PRIOR to the release of the assessment material.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name	Mark range	Description
High distinction	85 - 100
Distinction	75 - 84
Credit	65 - 74
Pass	50 - 64
Fail	0 - 49	When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

Deduction of 5% of the maximum mark for each calendar day after the due date.
After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

For every calendar day up to and including ten calendar days after the due date, a penalty of 5% of the maximum awardable marks will be applied to late work. (a) The penalty will be calculated by first marking the work, and then subtracting 5% of the maximum awardable mark for each calendar day after the due date. For work submitted more than ten calendar days after the due date a mark of zero will be awarded. The marker may elect to, but is not required to, provide feedback on such work.

Academic integrity

The Current Student website provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Weekly schedule

WK	Topic	Learning activity	Learning outcomes
Multiple weeks	This Unit has no Normal (lecture/lab/tutorial) day schedule.	Independent study (130 hr)

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

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.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1	Depth of disciplinary expertise Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.
GQ2	Critical thinking and problem solving Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.
GQ3	Oral and written communication Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.
GQ4	Information and digital literacy Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.
GQ5	Inventiveness Generating novel ideas and solutions.
GQ6	Cultural competence Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.
GQ7	Interdisciplinary effectiveness Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.
GQ8	Integrated professional, ethical, and personal identity An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.
GQ9	Influence Engaging others in a process, idea or vision.

Outcome map

Learning outcomes	Graduate qualities
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

No changes have been made since this unit was last offered

Additional information

Student hub - Professional Medical Education

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect

Current students

CLTR5009: Operational Principles of Clinical Trials

Semester 2, 2023 [Online] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect