Clinical Trial Site Monitoring

Subject CLRS90024 (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.

Prerequisites:

To enrol in this subject, you must be admitted in N01AA, N34AA, or GC-CRMONIT. This subject is not available for students admitted in any other courses.

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

School of Melbourne Custom Programs

Award Programs Team

Program Coordinator - Kathy Griffiths

Phone - (03) 9810 3174

Email: ClinicalResearch@commercial.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
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 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:	All class materials will be provided.
Recommended Texts:	NA
Breadth Options:	This subject is not available as a breadth subject.
Fees Information:	Subject EFTSL, Level, Discipline & Census Date
Links to further information:	http://www.commercial.unimelb.edu.au/courses
Related Course(s):	Graduate Diploma in Clinical Research Master of Clinical Research Specialist Certificate in Clinical Research-Clinical Trials Monitoring

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