Clinical Trial Site Establishment

Subject CLRS90023 (2015)

Note: This is an archived Handbook entry from 2015.

Credit Points: 12.5
Level: 9 (Graduate/Postgraduate)
Dates & Locations:

This subject has the following teaching availabilities in 2015:

February, Hawthorn - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period 10-Feb-2015 to 04-Jun-2015
Assessment Period End 04-Aug-2015
Last date to Self-Enrol 05-Mar-2015
Census Date 20-Mar-2015
Last date to Withdraw without fail 05-Jun-2015

July, Hawthorn - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period 14-Jul-2015 to 04-Dec-2015
Assessment Period End 04-Feb-2016
Last date to Self-Enrol 11-Aug-2015
Census Date 28-Aug-2015
Last date to Withdraw without fail 27-Nov-2015

Timetable can be viewed here. For information about these dates, click here.
Time Commitment: Contact Hours: 24 contact hours
Total Time Commitment:

170 hours per 12.5 credit point subject


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.



Recommended Background Knowledge:


Non Allowed Subjects:


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:


School of Melbourne Custom Programs

Award Programs Team

Program Coordinator - Kathy Griffiths

Phone - (03) 9810 3174


Subject Overview:

Topics covered in this subject include:
• Overview of Drug Development
• Conducting Clinical Research (CCR) - Essential GCP Training for New Coordinators
• Managing Regulatory Documents

Learning Outcomes:

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.

Prescribed Texts:

All class materials will be provided.

Recommended Texts:


Breadth Options:

This subject is not available as a breadth subject.

Fees Information: Subject EFTSL, Level, Discipline & Census Date
Links to further information:
Related Course(s): Graduate Diploma in Clinical Research
Master of Clinical Research
Specialist Certificate in Clinical Research-Clinical Trials Coordination

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