Clinical Trial Site Monitoring

This subject has the following teaching availabilities in 2012:

Face-to-Face Lecture

Estimated total time commitment of 160 hours.

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For the purposes of considering requests for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry.
The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website: http://www.services.unimelb.edu.au/disability/

Topics covered in this subject include:
• Overview of Drug Development
• Essential Good Clinical Practice Training for New Clinical Research Associates
• Managing Regulatory Documents

Students who successfully complete this subject will:
• 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

• One open book test representing 20% of the total mark, completed at the end of the first week of lectures.
• Two 1000 word assignment each representing 25% of the total mark (a combined total of 50%)
• One 1500 word workplace assignment representing 30% of the total mark.

Each written essay is due progressively through the semester.
A minimum score of 50% in each assessment is required for a student to pass this subject.

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This subject is not available as a breadth subject.

• Document management
• Legislative compliance
• Good clinical practice
• Risk management