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Clinical Trial Site Monitoring (CLRS90024)
Graduate courseworkPoints: 12.5Not available in 2018
Overview
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Topics covered in this subject include:
• Overview of Drug Development
• Essential Good Clinical Practice Training for New Clinical Research Associates
• Managing Regulatory Documents
Intended learning outcomes
Students who successfully complete this subject should:
- Understand the drug development pathway and its link to clinical research
- Understand the role of the Clinical Research Associate in clinical research
- Understand the purpose and role of regulatory documents necessary for initiating and running a clinical trial
- 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-CRMONIT. 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
- Open book test, completed at the end of the first week of lectures, (20%)
- 2 x 1,000 word assignments, (25% each - combined total of 50%)
- 1,500 word workplace assignment, (30%)
Each written essay is due progressively through the semester.
Hurdle Requirement: A minimum score of 50% in each assessment is required for a student to pass 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