Clinical Trial Site Establishment

This subject has the following teaching availabilities in 2014:

Face-to-Face Lecture

In addition to face-to-face teaching time, students should expect to undertake a minimum of 120 hours research, reading, writing assignments and general study to complete this subject successfully.

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.

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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
• Conducting Clinical Research (CCR) - Essential GCP Training for New Coordinators
• 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 research coordinator in clinical research
• Understand the purpose and role of regulatory documents for initiating and running a clinical trial
Understand the purpose and operational responsibilities of a research coordinator in maintaining the quality standards defined by Australian legislation and Good Clinical Practice

Assessment will include a combination of one open book test and three assignments.
• 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 submitted progressively through the semester.

A minimum score of 50% in each assessment is required for a student to pass this subject.

All class materials will be provided.

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This subject is not available as a breadth subject.