Skip to main content
Unit of study_

PUBH5216: Controlled Clinical Trials

Semester 2, 2022 [Normal day] - Camperdown/Darlington, Sydney

This unit introduces the principles underpinning the design and conduct of high quality controlled clinical trials to generate good evidence for health care decision making. The topics include clinical trial design, randomisation, sample size, measures of treatment effect, methodological issues, trial protocols, and ethical principles.

Unit details and rules

Unit code PUBH5216
Academic unit Public Health
Credit points 6
Prohibitions
? 
PUBH5206 - Controlled trials (2CP)
Prerequisites
? 
PUBH5018 or FMHU5002
Corequisites
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Chris Brown, c.brown@sydney.edu.au
Guest lecturer(s) Rebecca Mister, rebecca.mister@sydney.edu.au
Andrew Martin, a.martin@sydney.edu.au
Lecturer(s) Chris Brown, c.brown@sydney.edu.au
Type Description Weight Due Length
Online task Online quizzes
Online quizzes
10% Week 03 30mins
Outcomes assessed: LO1 LO6 LO5 LO4 LO3 LO2
Assignment Assignment
Scenario-based assignment
45% Week 07
Due date: 19 Sep 2022 at 23:59
3 weeks
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
Online task End of Semester Quiz
Online quiz
20% Week 13
Due date: 04 Nov 2022 at 23:59
1 hour
Outcomes assessed: LO1 LO6 LO5 LO4 LO3 LO2
Assignment End of Semester Assignment
Scenario-based assignment
25% Week 13
Due date: 04 Nov 2022 at 23:59
7 days
Outcomes assessed: LO1 LO6 LO5 LO4 LO3 LO2

Assessment summary

  • Short quizzes: Each quiz covers two modules. The quizzes are open book.
  • Mid-Semester assignment: Students will be required read a number of scenarios and respond to structured questions designed to evaluate their understanding of the material in the course.
  • End of semester quiz: Longer quiz covering the whole unit. 
  • End of semester assignment: Students will be required to read a number of scenarios and respond to structured questions designed to evaluate their understanding of the material in the course.

Detailed information for each assessment can be found on Canvas.

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:

• Late submissions that have not been granted extensions and are of a standard to receive a pass or higher mark will attract a penalty of 5% of the maximum mark per day late including weekend days (e.g. if the assignment is worth 40 marks, the penalty is 2 marks per day late) until the mark reaches 50% of the maximum mark (e.g. 20 marks if the maximum is 40 marks). • Submissions that are not of a pass standard will not have marks deducted and will fail regardless • Submissions more than 10 days late without prior approval from the unit of study coordinator will not be accepted and will be given a zero (0) mark

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.

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.

WK Topic Learning activity Learning outcomes

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 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. describe the features of high quality controlled clinical trials and determine the applicability of common designs for randomised controlled trials to a particular research question
  • LO2. demonstrate an understanding of the purpose of random treatment allocation and implementing common randomisation methods
  • LO3. demonstrate an understanding of the key issues in determining an adequate sample size for a randomised control trial
  • LO4. demonstrate awareness of the ethical principles of relevance to clinical trials
  • LO5. describe the main sections of a trial protocol
  • LO6. recognise, correctly interpret, and adequately manage key methodological and practical issues arising in the design, conduct, analysis, and interpretation of a randomised controlled trial.

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
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

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

Interactive zoom discussion tutorial sessions are now being run for all online students.

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.