Note: This is an archived Handbook entry from 2011.
|Dates & Locations:|| |
This subject has the following teaching availabilities in 2011:Semester 1, Hawthorn - Taught on campus.
Semester 2, Hawthorn - Taught on campus.
Timetable can be viewed here. For information about these dates, click here.
|Time Commitment:||Contact Hours: 24 contact hours |
Total Time Commitment: Estimated total time commitment of 160 hours.
|Recommended Background Knowledge:||nil|
|Non Allowed Subjects:||nil|
|Core Participation Requirements:||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/
ContactMelbourne Consulting and Custom Programs
Level 3, 442 Auburn Rd
Hawthorn VIC 3122
Phone: 9810 3185
|Subject Overview:||Topics covered in this subject include: |
• Overview of Drug Development
• Essential Good Clinical Practice Training for New Clinical Research Associates
• Managing Regulatory Documents
|Objectives:||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.
Each written essay is due progressively through the semester.
|Breadth Options:|| |
This subject is not available as a breadth subject.
|Fees Information:||Subject EFTSL, Level, Discipline & Census Date|
|Generic Skills:||• Document management |
• Legislative compliance
• Good clinical practice
• Risk management
|Links to further information:||www.mccp.unimelb.edu.au|
Specialist Certificate in Clinical Research-Clinical Trials Monitoring |
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