Clinical Trials and Regulations (BMEN90026)
Graduate courseworkPoints: 12.5On Campus (Parkville)
About this subject
Contact information
Semester 1
Overview
| Availability | Semester 1 |
|---|---|
| Fees | Look up fees |
AIMS:
This subject teaches fundamentals of probability and statistics, clinical trial processes and regulations of therapeutic goods and specialised health care environments to Master of Engineering (Biomedical) students.
INDICATIVE CONTENT:
Foundations of probability: independence, conditional probability, Bayes’ rule; Random variables: cumulative distributions, probability mass and probability density functions, expectation and variance, functions of a random variable, important distributions and their properties and uses; Sums, inequalities and limit theorems: Basic statistical concepts: confidence intervals, hypothesis testing, significance levels, correlation, analysis of variance; Decision testing: maximum likelihood, maximum a posteriori, minimum cost and Neyman-Pearson rules, basic minimum mean-square error estimation, regression.
Risk management and international and Australian regulatory guidelines for electrical, chemical, biological and administrative health care processes, in particular medical devices: regulations, classifications and standards; familiarisation with specialised clinical/laboratory environmental control and containment guidelines; ethical standards and sponsor responsibilities.
Clinical trials: Design and analysis of experiments; Clinical trials and ethical consent; Principles of drug development: Global regulation and harmonisation of format of processes, decisions and good clinical practices; Institutional structures, product information and guidelines: clinical trials notification schemes, human ethics, chemical, synthesis and property drug information, and drug guidelines; Drug regulation in Australia.
Intended learning outcomes
INTENDED LEARNING OUTCOMES (ILOs)
Having completed this subject it is expected that the student be able to:
- Demonstrate an understanding of the axioms of probability, random variables, Bayes’ rule, and the ability to calculate and interpret probabilities, probability densities, means, variances and covariances
- Demonstrate the ability to fit probability models to data by both estimating and testing hypotheses about model parameters
- Apply standard statistical procedures using a statistical computing package
- Describe the appropriate standards used in the design and maintenance of biomedical devices and the appropriate schedules in the distribution of therapeutic agents
- Describe the regulations that are required to place a new medical device or a therapeutic agent into a clinical trial and then market
- Describe important processes of experimental design in pre-clinical and clinical trials
- Describe the therapeutic device/agents post-market evaluation and incident reporting schemes
- Discuss the ethics, standards and regulations applicable to the development of therapeutic devices and/or agents in Australia and overseas.
Generic skills
On completion of this subject, students should have developed the following generic skills:
- Understanding of social, cultural, global, and environmental responsibilities and the need to employ principles of sustainable development
- Ability to communicate effectively, with the engineering team and with the community at large
- Ability to manage information and documentation
- Understanding of professional and ethical responsibilities, and commitment to them
- Ability to function effectively as an individual and in multidisciplinary and multicultural teams, as a team leader or manager as well as an effective team member.
Last updated: 3 November 2022
Eligibility and requirements
Prerequisites
| Code | Name | Teaching period | Credit Points |
|---|---|---|---|
| BMEN30008 | Biosystems Design | Semester 2 (On Campus - Parkville) |
12.5 |
Corequisites
None
Non-allowed subjects
BMEN90020
Inherent requirements (core participation requirements)
The University of Melbourne is committed to providing students with reasonable adjustments to assessment and participation under the Disability Standards for Education (2005), and the Assessment and Results Policy (MPF1326). Students are expected to meet the core participation requirements for their course. These can be viewed under Entry and Participation Requirements for the course outlines in the Handbook.
Further details on how to seek academic adjustments can be found on the Student Equity and Disability Support website: http://services.unimelb.edu.au/student-equity/home
Last updated: 3 November 2022
Assessment
Additional details
- Continuous assessment of submitted project work completed in small groups (2-3 students), requiring 40-45 hours of work per student across the semester (weeks 2-12), worth 30%. ILOs 1-8 are assessed in these workshops
- One mid-semester test of 50 minutes duration in weeks 6- 8, worth 10%
- One examination of three hours duration at the end of semester (exam period), worth 60%.
Hurdle requirement: Students must pass the end of semester examination to pass the subject.
Intended Learning Outcomes (ILOs) 1-8 are assessed in the final exam, and continuous assessment of submitted project work. (ILOs) 1-6 are also assessed in the mid-semester test.
Last updated: 3 November 2022
Dates & times
- Semester 1
Principal coordinator Emmanuel Koumoundouros Mode of delivery On Campus (Parkville) Contact hours 36 hours of lecture (3 x 1 hour lectures per week) and up to 24 hours of workshops Total time commitment 200 hours Teaching period 27 February 2017 to 28 May 2017 Last self-enrol date 10 March 2017 Census date 31 March 2017 Last date to withdraw without fail 5 May 2017 Assessment period ends 23 June 2017 Semester 1 contact information
Time commitment details
200 hours
Last updated: 3 November 2022
Further information
- Texts
- Related Handbook entries
This subject contributes to the following:
Type Name Specialisation (formal) Biomedical with Business Informal specialisation Master of Engineering (Biomedical) Specialisation (formal) Biomedical Informal specialisation Master of Engineering (Biomedical with Business) - Available through the Community Access Program
About the Community Access Program (CAP)
This subject is available through the Community Access Program (also called Single Subject Studies) which allows you to enrol in single subjects offered by the University of Melbourne, without the commitment required to complete a whole degree.
Please note Single Subject Studies via Community Access Program is not available to student visa holders or applicants
Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.
Additional information for this subject
Subject coordinator approval required
Last updated: 3 November 2022