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Study Design in Clinical Research (CLRS90011)
Graduate courseworkPoints: 12.5On Campus (Parkville)
About this subject
- Overview
- Eligibility and requirements
- Assessment
- Dates and times
- Further information
- Timetable(opens in new window)
Contact information
May
School of Melbourne Custom Programs
Currently enrolled students:
- General information:http://go.unimelb.edu.au/22wa
- Email:TL-ClinicalResearch@unimelb.edu.au
Future students:
- Further information:http://go.unimelb.edu.au/22wa
- Email:TL-ClinicalResearch@unimelb.edu.au
Overview
Availability | May |
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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 CLRS90027 Principles of Clinical Research
Code | Name | Teaching period | Credit Points |
---|---|---|---|
CLRS90027 | Principles of Clinical Research | March (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
Additional details
- 60 min examination (equivalent to 1000 words) on the last day of intensive 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) (40%)
- Design and critical discussion/justification of a clinical research study using a scenario selected by negotiation with the Subject Co-ordinators (equivalent to 2000 words) due 2 weeks after completion of intensive teaching period (40%)
Last updated: 3 November 2022
Dates & times
- May
Mode of delivery On Campus (Parkville) Contact hours Approx. 32 hours (4 day intensive block) Total time commitment 170 hours Teaching period 8 May 2017 to 11 May 2017 Last self-enrol date 8 May 2017 Census date 11 May 2017 Last date to withdraw without fail 20 May 2017 Assessment period ends 26 May 2017 May contact information
School of Melbourne Custom Programs
Currently enrolled students:
- General information:http://go.unimelb.edu.au/22wa
- Email:TL-ClinicalResearch@unimelb.edu.au
Future students:
- Further information:http://go.unimelb.edu.au/22wa
- Email:TL-ClinicalResearch@unimelb.edu.au
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 Graduate Diploma in Clinical Research Course Master of Clinical Research Course Professional Certificate in Clinical Research - Links to additional information
Last updated: 3 November 2022