Clinical Trial Site Monitoring

Subject CLRS90024 (2011)

Note: This is an archived Handbook entry from 2011.

Credit Points:

12.50

Level:

9 (Graduate/Postgraduate)

Dates & Locations:

This subject has the following teaching availabilities in 2011:

Semester 1, Hawthorn - Taught on campus.

Pre-teaching Period Start	not applicable
Teaching Period	not applicable
Assessment Period End	not applicable
Last date to Self-Enrol	not applicable
Census Date	not applicable
Last date to Withdraw without fail	not applicable

Semester 2, Hawthorn - Taught on campus.

Pre-teaching Period Start	not applicable
Teaching Period	not applicable
Assessment Period End	not applicable
Last date to Self-Enrol	not applicable
Census Date	not applicable
Last date to Withdraw without fail	not applicable

Face-to-Face Lecture

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.

Prerequisites:

nil

Corequisites:

nil

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/

Contact

Melbourne Consulting and Custom Programs
Level 3, 442 Auburn Rd
Hawthorn VIC 3122
Phone: 9810 3185
Email: clinicalresearch@mccp.unimelb.edu.au

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
Assessment:	• 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.
Prescribed Texts:	nil
Recommended Texts:	NA
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
Related Course(s):	Specialist Certificate in Clinical Research-Clinical Trials Monitoring

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