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Clinical Trial Site Coordination (CLRS90022)
Graduate courseworkPoints: 12.5Not available in 2018
Overview
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In this subject, students will select a minimum of 10 hours of electives depending on their needs plus a compulsory capstone component.
Electives (minimum of 10 hours of teaching).
• Assertiveness in the workplace (7 hours) or Managing and Resolving Conflict (7 hours)
• Fundamentals of project management (7 hours)
• Statistics for non-statisticians (14 hours)
• Managing laboratories in clinical research (14 hours)
• Effective management of GCP issues (3 hours)
• Introduction to pharmacovigilance (3 hours)
• Research ethics and governance (3 hours)
Capstone
• Coordinating single and multi-centre clinical research more effectively (14 hours)
Intended learning outcomes
Students who successfully complete this subject should:
- Understand how to effectively coordinate research activities at a clinical research site
- Understand and manage risk at a clinical research site
- Understand the role of project management in good clinical practice
- Be able to provide input in the implementation of clinical research studies within Australia
- Understand the purpose and operational responsibilities of a Clinical Research Associate in maintaining the quality standards defined by Australian legislation and Good Clinical Practice
Last updated: 3 November 2022
Eligibility and requirements
Prerequisites
To enrol in this subject, you must be admitted in N01AA, N34AA, or GC-CRCOORD. This subject is not available for students admitted in any other courses.
Corequisites
nil
Non-allowed subjects
nil
Recommended background knowledge
nil
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
Assessment for this subject will be based around the individual modules, plus an overall assessment of the content of the two subjects. This will comprise:
- 2,000 word assignments for the electives, (40%)
- 2,000 word assignment for the capstone module,(40%)
- 1,000 word workplace assignment representing, (20%)
Each assessment piece is due four weeks after the relevant lecture.
Hurdle Requirement: Students must achieve a mark of at least 50% in each of the assessments to achieve a pass grade for this subject.
Last updated: 3 November 2022
Dates & times
Not available in 2018
Time commitment details
170 hours per 12.5 credit point subject.
Last updated: 3 November 2022
Further information
- Texts
Prescribed texts
All class materials will be provided.
Recommended texts and other resources
NA
- Links to additional information
Last updated: 3 November 2022