Course Coordinators: Associate Professor Amy Salter and Dr Angela Gialamas

Please contact Dr Gialamas for any queries related to this course
Phone: +61 8313 0962 
Email: angela.gialamas@adelaide.edu.au 
Location: Level 4, Rundle Mall Plaza, North Terrace Adelaide

Timetable details are located on MyUni.

1   Apply common clinical trial design features appropriately in addressing research questions

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2   Distinguish between primary and secondary outcome variables and demonstrate knowledge of different types of variables

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3   Apply a range of simple and complex statistical analysis techniques commonly used in clinical trials, including intention to treat, per protocol and as treated approaches

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4   Demonstrate statistical reasoning skills correctly with unadjusted and adjusted parallel group analyses

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5   Interpret and communicate critiques of published literature against the CONSORT statement

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6   Use ‘Stata’ statistical software proficiently to conduct unadjusted and adjusted parallel group analyses and interpret relevant output

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The textbooks for this course are:
1. Matthews N.S. Introduction to Randomized Controlled Clinical Trials (2nd edition). 2006; Chapman and Hall.
2. Bland M. An Introduction to Medical Statistics (4th edition). 2015; Oxford University Press.

Please note: The text book by Matthews and the first edition of the text by Bland (with equivalent recommended readings) are available online via the Barr Smith Library.

A list of recommended resources that will supplement the lectures, text book and readings, will be provided on MyUni ahead of each teaching week.

MyUni
As an enrolled student, you will have access to the University’s online teaching facility, known as MyUni. MyUni is accessible from the University of Adelaide’s home-page: www.adelaide.edu.au

You will need your student login name and a password.

If you do not have access, then either you are not enrolled or the administrators of MyUni do not know of your enrolment. Please call Ask Adelaide on 8313 5208 or the MyUni help desk 8313 3000 for assistance with MyUni difficulties.

Course materials will be placed on MyUni including lecture slides, lecture recordings, tutorials, and practicals. Note also that Announcements about the course will be made on MyUni.

Email
We assume that you have access to email and that your address is the University of Adelaide student address that was assigned to you on enrolment.

Lectures are intended to introduce concepts and illustrate their use.

Tutorials and Computer Practicals provide an interactive forum to apply concepts from lectures and clarify understanding. In the series of computer practicals a statistical package (Stata) will be used to analyse data.

Assignments provide an opportunity for independent application and exploration of key concepts, for wider reading and for synthesis of concepts and literature.

The exam provides an opportunity for students to demonstrate what they have learnt, drawing together concepts and showing that they understand key concepts in the design and analysis of experimental studies.

Enrolment in Experiments with Humans begins with the assumption that students are active participants in the learning process, rather than passive recipients of information. We assume that you are willing and able to prepare fully for classes, to participate in discussions and to carry your share of the workload.

As a general rule, in any university course you will need to allow a minimum of 3 independent study hours for every hour undertaken in formal class work contact. This means that you will have to set aside at least a further 9 hours per week for reading around topics, preparation for class activities, and work on assignments.

You are urged to bear this in mind when planning your university timetable, particularly if you are also engaged in paid employment. In our experience, students may not be able to demonstrate their full capacity if they are working full-time and studying full-time.

A detailed timetable of classes and assessment tasks will be available in the course Handbook, and on MyUni. The topics covered in lectures, tutorials and practicals include the following materials within the context of real-life motivating experiments:

- History of clinical trials
- Phase I-IV trials
- Governance and Regulatory framework
- Features of a Randomised Controlled Trial
- The CONSORT statement
- Constructing Research Hypotheses
- Principles of Statistical Inference
- Confidence interval estimation
- Sample size estimation
- Statistical analyses of continuous and binary outcomes
- Univariable and adjusted analyses
- Critical appraisal of published study results using the CONSORT guidelines

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Tutorial & Practical preparation       Summative                        10%                            1 - 6 
and participation

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Assignment 1: Importance of          Summative                         5%                            1, 2
Randomised Controlled Trials

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Assignment 2: Addressing the         Summative                        25%                           1, 2, 5
CONSORT statement

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Assignment 3: Analysis and            Summative                        25%                            3 - 6
reporting of RCTs

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Exam                                            Summative                        35%                            1 - 6

A basic proficiency with numerical methods and a familiarity with statistical concepts introduced in PUB HLTH 2007 or equivalent is assumed. The level is somewhere around that of Year 10 of secondary school. 

To pass this course, a student must submit all three assignments and score at least 50% overall (for combined component assessments).

Tutorial and practical preparation and participation (10%)
Unless otherwise indicated, each week you will be required to prepare answers to tutorial and practical questions prior to class. Further details can be found in the Course Handbook and on MyUni.

Assignment 1 (5%)
Understanding the importance of Randomised Controlled Trials

Assignment 2 (25%)
Addressing the CONSORT statement

Assignment 3 (25%)
Analysis and reporting in Randomised Controlled Trials

Examination (35%)

All assessment tasks will be made available on MyUni at least 2 weeks prior to the date of submission. All assessment tasks will be assessed according to the University’s M10 mark scheme.

Assignments should be submitted online through MyUni. Assignments must be submitted by 11:59pm on the due date.

A mixture of typeset and handwritten assignments are acceptable (especially for mathematical work) provided that they are neat and legible. All assignments must be scanned and submitted electronically (as word or pdf documents).

Each page of an assignment should be numbered and the total number of pages should appear on each page (e.g. “page 2 of 4” or “2/4”). The first page should bear the student’s name and student number; each subsequent page should bear, at least, the student’s initials.

Marked assignments will be available through MyUni.

Extensions
All extensions for assignments must be requested, at the latest, by the last working day before the due date of submission. Extensions will generally be granted only on medical or genuine compassionate grounds. Supporting documentation must be provided at the time a student requests an extension. Without documentation, extensions will not be granted. Late requests for extension will neither be accepted nor acknowledged.

Only the Course Co-ordinator may grant extensions.

Supporting documentation will be required when requesting an extension. Examples of documents that are acceptable include: a medical certificate that specifies dates of incapacity, a police report (in the case of lost computers, car & household theft etc.), a letter from a Student Counsellor, Education and Welfare Officer (EWO) or Disability Liaison Officer that provides an assessment of compassionate circumstances, or a letter from an independent external counsellor or appropriate professional able to verify the student’s situation. The length of any extension granted will take into account the period and severity of any incapacity or impact on the student. Extensions of more than 10 days will not be granted except in exceptional circumstances.

Late submission
Marks will be deducted when assignments for which no extension has been granted are handed in late.

All assignments, including those handed in late, will be assessed on their merits. In the case of late assignments where no extension has been granted, 5 percentage points of the total marks possible per day will be deducted. If an assignment that is 2 days late is awarded 65% on its merits, the mark will then be reduced by 10% (5% per day for 2 days) to 55%. If that same assignment is 4 days late, the mark will be reduced by 20% (5% per day for 4 days) to 45%, and so on.

Assignments submitted after the due date may not be graded in time to be returned on the listed return dates. The School of Public Health reserves the right to refuse to accept an assignment that is more than 7 days late.

Students submitting examinable written work who request (and receive) an extension that takes them beyond the examination period are advised that there is no guarantee that their grades will be processed in time to meet usual University deadlines.

Resubmission
If a student is dissatisfied with an assessment grade they should follow the Student Grievance Resolution Process <https://www.adelaide.edu.au/student/grievance/>. Students who are not satisfied with a particular assessment result should raise their concerns with Course Co-ordinator(s) in the first instance. This must be done within 10 business days of the date of notification of the result. Resubmission of any assignment is subject to the agreement of the Course Co-ordinator(s) and will only be permitted for the most compelling of reasons.