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Study Design in Clinical Research (CLRS90011)
Graduate courseworkPoints: 12.5On Campus (Parkville)
For information about the University’s phased return to campus and in-person activity in Winter and Semester 2, please refer to the on-campus subjects page.
About this subject
- Overview
- Eligibility and requirements
- Assessment
- Dates and times
- Further information
- Timetable(opens in new window)
Contact information
February
Further Information: https://study.unimelb.edu.au/find/courses/graduate/graduate-certificate-in-clinical-research/
Semester 2
Email: continuing-education@unimelb.edu.au
Phone: + 61 3 8344 0149
Contact hours: https://unimelb.edu.au/professional-development/contact-us
Please refer to the LMS for up-to-date subject information, including assessment and participation requirements, for subjects being offered in 2020.
Overview
Availability | February Semester 2 |
---|---|
Fees | Look up fees |
Identifying the most appropriate study design is important for generating the best evidence to answer a clinical research question. A well-designed study will clearly identify a range of variables including the participant population, the intervention or exposure of interest and the outcomes to be investigated and how data will be collected. Understanding the various indications for different study designs is important for not only devising a new study but also for critically reviewing published studies.
This subject will provide students with an in-depth understanding of the principles and application of a variety of study designs in a clinical/medical setting. Key areas that will be covered include:
1. examining the range of quantitative, qualitative and mixed-methods approaches such as
- experimental and quasi-experimental, cohort, cross-sectional and single-subject designs;
- participant observation, in-depth interviews, case-studies, focus groups and artefact analysis designs;
- screening, preventive and genetic/biomarker trials
- construction and administration of surveys and questionnaires and;
- the use of clinical bioinformatics, e-health and large population datasets.
2. strategies for matching study aims/objectives with selection of an appropriate study design
3. exploring sources of bias in research such as randomization, allocation, concealment and blinding and their relationship to the principles of internal and external validity
4. using published reporting guidelines (eg CONSORT statement) to aid in the design and reporting of a study
5. participant recruitment/retention/attrition, outcome measure selection and the application of power calculations
6. the principles of drug evaluation and regulation
Intended learning outcomes
On completion of this subject students should be able to:
- describe the essential elements of a range of quantitative, qualitative and mixed-methods study designs
- critically appraise the application, strengths and limitations of a range of quantitative, qualitative and mixed-methods study designs
- develop a strategy to identify and select an appropriate study design required to answer a specific research question.
- critically discuss the implications of poor study design, or inappropriate design selection, on outcome selection, measurement and analysis
- discuss issues associated with the concepts of internal and external validity.
- design a clinical research study and justify selection of different design elements
- demonstrate expertise in reporting on the critical appraisal and quality assessment of published clinical research studies
Generic skills
Students who successfully complete this course should gain:
- An understanding of the context of research and how it advances knowledge
- An understanding of the complexities of research activities
- An appreciation of the limitations of research findings
- Clearer understanding of the principles of research design
- Attention to detail
Last updated: 3 November 2022
Eligibility and requirements
Prerequisites
To enrol in this subject, you must have completed the below subject. This subject can be completed concurrently.
Code | Name | Teaching period | Credit Points |
---|---|---|---|
CLRS90027 | Principles of Clinical Research | January (On Campus - Parkville) |
12.5 |
Corequisites
None
Non-allowed subjects
None
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
Due to the impact of COVID-19, assessment may differ from that published in the Handbook. Students are reminded to check the subject assessment requirements published in the subject outline on the LMS
Description | Timing | Percentage |
---|---|---|
Examination (equivalent to 1000 words) on the last day of intensive teaching period
| End of the teaching period | 20% |
2 x 10min group presentation during the intensive teaching period, describing a critical evaluation of a selection of published clinical research trials (equivalent to 2000 words)
| During the teaching period | 40% |
Design and critical discussion/justification of a clinical research study using a scenario selected by negotiation with the Subject Co-ordinators
| 2 Weeks after the end of teaching | 40% |
Last updated: 3 November 2022
Dates & times
- February
Principal coordinator Ken Chin Mode of delivery On Campus (Parkville) Contact hours Total time commitment 170 hours Teaching period 23 February 2020 to 26 March 2020 Last self-enrol date 28 February 2020 Census date 3 April 2020 Last date to withdraw without fail 4 April 2020 Assessment period ends 20 April 2020 February contact information
Phone: + 61 3 8344 0149 Monday to Friday 8am to 9pm. Weekends and University of Melbourne observed Public Holidays 10am to 5pm.
Further Information: https://study.unimelb.edu.au/find/courses/graduate/graduate-certificate-in-clinical-research/ - Semester 2
Coordinator Anita Horvath Mode of delivery On Campus (Parkville) Contact hours Total time commitment 170 hours Teaching period 3 August 2020 to 1 November 2020 Last self-enrol date 14 August 2020 Census date 21 September 2020 Last date to withdraw without fail 16 October 2020 Assessment period ends 27 November 2020 Semester 2 contact information
Email: continuing-education@unimelb.edu.au
Phone: + 61 3 8344 0149
Contact hours: https://unimelb.edu.au/professional-development/contact-us
Time commitment details
170 hours
Last updated: 3 November 2022
Further information
- Texts
Prescribed texts
Recommended texts and other resources
Students will be provided with articles and references that support the teaching program as part of their course materials.
- Related Handbook entries
This subject contributes to the following:
Type Name Course Graduate Certificate in Clinical Research Course Master of Clinical Research Course Graduate Diploma in Clinical Research - Links to additional information
- 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.
Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.
- Available to Study Abroad and/or Study Exchange Students
This subject is available to students studying at the University from eligible overseas institutions on exchange and study abroad. Students are required to satisfy any listed requirements, such as pre- and co-requisites, for enrolment in the subject.
Last updated: 3 November 2022