Clinical Trial Site Monitoring

Subject CLRS90024 (2016)

Note: This is an archived Handbook entry from 2016.

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

This subject has the following teaching availabilities in 2016:

February, Hawthorn - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period 09-Feb-2016 to 02-Jun-2016
Assessment Period End 02-Aug-2016
Last date to Self-Enrol 03-Mar-2016
Census Date 18-Mar-2016
Last date to Withdraw without fail 03-Jun-2016

July, Hawthorn - Taught on campus.
Pre-teaching Period Start not applicable
Teaching Period 12-Jul-2016 to 02-Dec-2016
Assessment Period End 02-Feb-2017
Last date to Self-Enrol 09-Aug-2016
Census Date 26-Aug-2016
Last date to Withdraw without fail 25-Nov-2016


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 (Commonwealth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this course are articulated in the Course Overview, Objectives and Generic Skills sections of this entry.

It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this course are encouraged to discuss this matter with the Student Equity and Disability Support Team: http://www.services.unimelb.edu.au/disability/

Contact

School of Melbourne Custom Programs

Currently enrolled and future students:

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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