Clinical Biostatistics (STAT7605)

Course overview

Clinical biostatistics covers a range of statistical methods in clinical research that are important for practising biostatisticians, especially those working in clinical settings or, more generally, evidence-based health care. These include a) Statistical Process Control (e.g. understanding special and common causes of variation, understanding and creating quality control charts). b) Clinical Agreement (concept of validity, reliability and agreement and using graphical and statistical methods to assess agreement (Bland-Altman methods, kappa statistics, intraclass correlation). Diagnostic tests (understanding sensitivity, specificity, ROC curves and AUC), systematic reviews and meta-analysis (assessing heterogeneity, publication bias, estimating effects from randomised controlled trials, diagnostic tests and observational studies), and Clinical Trials (equivalence trials, cross-over trials).

For more information about this course please contact the course coordinator. This course is part of the Biostatistics Collaboration of Australia (BCA). If you are not enrolled in a Biostatistics program at UQ, please contact the Program Director, Dr Michael Waller, to seek permission before enrolling.

This unit or course comprises the following four topics

1. continuous quality improvement (statistical process control)
2. clinical agreement
3. diagnostic tests and systematic reviews
4. clinical trials

These topics are important for practising biostatisticians, especially those working in clinical epidemiology or, more generally, evidence-based health care. The topics are more or less independent and not closely inter-related. Each topic is covered in a module designed to take 2-4 weeks to complete.

Course requirements

Assumed background

The course is offered as part of the Biostatistics Collaboration of Australia (BCA) program and assumes knowledge of basic statistical methods, at the level of the SPH course PUBH7630 Introduction to Biostatistics.

Prerequisites

You'll need to complete the following courses before enrolling in this one:

(STAT7601 + STAT7614) or STAT7617

Recommended prerequisites

We recommend completing the following courses before enrolling in this one:

PUBH7600 + STAT7604 + STAT7606 + STAT7618

Course contact

Course staff

Timetable

Additional timetable information

There are currently 5 Consortium Universities offering the program in biostatistics. You can enrol in your choice of consortium university, having regard in particular to the availability of local support and supervision. There are, however, no Australian residential requirements. You can study from home and tailor your study program to fit in with work commitments.

Aims and outcomes

Learning outcomes

After successfully completing this course you should be able to:

Assessment

Assessment summary

Assessment details

Module 1 and 2

Mode

Written

Category

Paper/ Report/ Annotation

Weight

30%

Due date

3/04/2025 5:00 pm

Learning outcomes

L01, L02, L03, L04, L05, L06, L07, L08, L09

Task description

Submission guidelines

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Extension is available for Assessment if extension application approved by school.

Please see 10. Policies & Guidelines

Late submission

Please see 10. Policies & Guidelines

Module 3

Mode

Written

Category

Paper/ Report/ Annotation

Weight

35%

Due date

12/05/2025 5:00 pm

Learning outcomes

L01, L02, L03, L04, L05, L06, L07, L08, L09

Task description

Submission guidelines

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

aximumExtension is available for Assessment if extension application approved by school

Please see 10. Policies & Guidelines

Late submission

Please see 10. Policies & Guidelines

Module 4

Mode

Written

Category

Paper/ Report/ Annotation

Weight

35%

Due date

30/05/2025 5:00 pm

Learning outcomes

L01, L02, L03, L04, L05, L06, L07, L08, L09

Task description

Submission guidelines

Deferral or extension

You may be able to apply for an extension.

The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.

Extension is available for Assessment if extension application approved by school

Please see 10. Policies & Guidelines

Late submission

Please see 10. Policies & Guidelines

Course grading

Full criteria for each grade is available in the Assessment Procedure.

Additional course grading information

More information on this course is available from the BCA website,ﾠhttps://www.bca.edu.au/curriculum/

Supplementary assessment

Supplementary assessment is available for this course.

Additional assessment information

All assignments should be submitted via the Canvas site hosted by the University of Sydney.

Additional Information on Supplementary Assessment

The final grade awarded will be based on the results of the supplementary assessment only, and a passing grade will be awarded if, and only if, the student receives at least 50% of the marks on the supplementary assessment. 

Learning resources

You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.

Library resources

Library resources are available on the UQ Library website.

Additional learning resources information

All students are provided with theﾠClinical Biostatistics study guideﾠ(provided to students on the eLearning web site, Canvas).

R or Stata is recommended, although students have successfully completed this course using SAS. Excel is also quite useful for several modules. Code and output in the module notes are given in both R and Stata, and students may choose to work in either software languages. We are not aware of any major differences between recent Stata versions (Stata 12-17) that affect the material, but minor issues will be pointed out in eLearning postings.ﾠData sets for the course are provided on the CLB eLearningﾠsite.ﾠ

A variety of resources are available for R including documentation at https://www.r-project.org/other-docs.html and various methods of getting help at https://www.r-project.org/help.html.

At UQ, the Library runs short introductory R courses. Similar courses may also be available at other universities. Short courses in Stata are also available to students. These courses are not an entry requirement for enrolment in the BCA program. However, you may find them useful as both packages are used in BCA units of study. The BCA curriculum also contains introductions to the R and Stata in the the unit, Data Management and Statistical Computing, and additional student resources are availableﾠon the BCA Canvas Site.ﾠ

SAS courses can be found at:ﾠhttp://support.sas.com/training/index.html

Stata courses can be found at: http://www.stata.com/netcourse/

Learning activities

The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.

Policies and procedures

University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:

• Student Code of Conduct Policy
• Student Integrity and Misconduct Policy and Procedure
• Assessment Procedure
• Examinations Procedure
• Reasonable Adjustments for Students Policy and Procedure
• AI for Assessment Guide

Learn more about UQ policies on my.UQ and the Policy and Procedure Library.

Course guidelines

 School of Public Health (SPH) Guidelines for late submission of progressive assessment - Preamble 

To apply for an extension to the due date for a piece of progressive assessment (eg assignments, oral presentations and computer-based assignments) students should complete the online request at https://my.uq.edu.au/information-and-services/manage-my-program/exams-and-assessment/applying-assessment-extension?p=2#2   

Information regarding deferral of in-semester exams and end-of-semester exams is available from https://my.uq.edu.au/information-and-services/manage-my-program/exams-and-assessment/deferring-exam   

If requesting an extension on medical grounds, a medical certificate must be provided. The extension will be approved for the number of days included in the medical certificate that the student was not fit to study or work, eg if the medical certificate is for 3 days only, an extension will be approved for 3 days maximum regardless of the student's request for further days.  

If requesting an extension using a Student Access Plan (SAP) as evidence, a maximum of 7-day extension will be approved in the first instance. Updated medical documentation, as well as a copy of the SAP, is required if requesting an extension for more than 7 days.  

A student may have a maximum of three extension requests approved for a single assessment task.     

An extension for an assessment item due within the study period in which the course is offered, must not exceed four weeks in total.   

The following SPH guidelines are consistent with the UQ policy. However, the SPH Guidelines  contain specific rules and interpretations for SPH courses, and requests for extension and penalties for late submissions will be judged according to the guidelines outlined in this document. You should read both the information in your my.UQ at the following link:  https://my.uq.edu.au/information-and-services/manage-my-program/exams-and-assessment/applying-assessment-extension  and the SPH guidelines (below) before submitting a request for an extension. The SPH Guidelines apply to all courses offered by the School of Public Health unless the Course Profile explicitly states otherwise. 

SPH Guidelines for late submission of progressive assessment 

Initial extension for an individual item of assessment – the SPH Student & Academic Administration Team and/or the Course Coordinator decides. 

This could be for medical or compassionate reasons, or if, in the opinion of the Course Coordinator, there are exceptional circumstances. 

Acceptable and unacceptable reasons for an extension are listed at the following link, along with the required evidence to be provided: https://my.uq.edu.au/information-and-services/manage-my-program/exams-and-assessment/applying-assessment-extension?p=1#1  

A request for an extension to an assessment due date must be submitted through my.UQ as soon as it becomes evident that an extension is needed, but no later than one calendar day after the assessment task submission due date and time.   

If applying for an extension after the due date and time of the assessment item, your request may not be approved. An explanation as to why your request was not submitted prior must be included.  

If approved, a new due date will be set. This would generally be no later than 7 days after the original due date, however this can be modified to account for the circumstances of the request and the time that would have been lost from studies. 

If the new due date is past the date for submission of end-of-semester results, the student will receive an INC (incomplete) result. 

Second and all subsequent extensions for an individual item of assessment – the SPH Student & Academic Administration Team and/or the Program Convenor together with the Course Coordinator decides. 

This would only be approved for exceptional circumstance with supporting documentation. 

• Online requests must be made at least 24 hours prior to the approved due date from the first extension. 
• The SPH Student & Academic Administration Team and/or the Course Coordinator will consult with the Program Convenor, who will make the final decision. 
• If approved, the new due date would generally be no later than 7 days after the first extension due date. 
• The Program Convenor should consider if remedial or other support should be offered to the student. 
• The Program Convenor should provide a report on these matters as needed at SPH Examiners’ Meetings. 

A student may have a maximum of three extension requests approved for a single assessment task.     

An extension for an assessment item due within the study period in which the course is offered, must not exceed four weeks in total.   

Please Note: To support course progression, extensions that total more than 14 calendar days from the original due date of an assessment item will only be approved in very exceptional circumstances. These requests are assessed and approved or denied on a case-by-case basis.  

If you have been ill or unable to attend class for more than 4 weeks in a semester, we advise you to carefully consider whether you are capable of successfully completing your courses this semester. You might need to consider Removal of Course. 

Penalty for late submission 

Submission of assignments, practical reports, workbooks, and other types of written assessments after the due date specified in the Course Profile will receive a penalty. 

The penalty will be a deduction of 10% RELATIVE PERCENTAGE per day (24 hour period or part thereof, including weekends and public holidays) or for work graded on a 1-7 scale, a deduction of one grade per day, e.g. If the original mark is 73%, then 10% relative percentage is 10% of this value, ie 7.3%, The final mark for this assessment item after applying the penalty for 1 day late submission would be 73 -7.3 = 65.7% The same outcome is achieved by multiplying the original score by .9; ie 73 x .9 = 65.7% 

The penalty for multiple days late is the relative percentage multiplied by the number of days late.  

A submission that is not made within 10 days of the due date will receive a mark of 0% for that assessment item. 

Where a student has sought more than one extension, the due date for calculating the penalty will be the due date for the most recently approved extension. 

Submission of Medical Certificates 

Students are responsible for ensuring that any medical documentation they submit is authentic and signed by a registered medical practitioner. Such practitioners can be identified via the AHPRA website. Also note that: 

• Not all online medical services are staffed by registered practitioners 
• If the registration status of the practitioner cannot be verified, then an alternative practitioner should be sought 
• Students will be held fully responsible for all documentation they submit, even if done so in ignorance of the practitioner's registration status 

Medical documentation may be subjected to an audit by the University. 

SPH Assessment Guidelines 

The School of Public Health assessment tasks have been designed to be challenging, authentic and complex.  While students may use AI technologies, successful completion of assessment in this course will require students to critically engage in specific contexts and tasks for which artificial intelligence will provide only limited support and guidance.  

A failure to reference AI use may constitute student misconduct under the Student Code of Conduct.  

To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI tools.