Clinical Immunisation Research

Subject CLRS90007 (2010)

Note: This is an archived Handbook entry from 2010.

Credit Points:

12.50

Level:

9 (Graduate/Postgraduate)

Dates & Locations:

This subject has the following teaching availabilities in 2010:

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

Intensive Mode

Timetable can be viewed here. For information about these dates, click here.

Time Commitment:

Contact Hours: Twenty-four hours of lectures/seminars/workshops
Total Time Commitment: Students should expect to undertake a minimum of 120 hours lectures, research, reading, writing etc (including face to face contact) to complete this subject successfully.

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 3300

email: clinicalresearch@mccp.unimelb.edu.au

Subject Overview:	Topics covered include: Recruitment strategies for immunisation studies Population versus intervention studies Ethics of conduct of studies in the developed and developing worlds The informed consent process in immunisation The role of control arms and where they are appropriate Differences in immune responses with age How to conduct vaccine studies including immunogenicity, efficacy, effectiveness and safety Post marketing studies Specific diseases will be used as examples. These will include meningococcal, rotavirus, influenza and pneumococcal
Objectives:	Students who successfully complete this subject will be able to:  Understand the basic principles of immunisation  Understand the methods employed in the conduct of immunisation clinical trials  Understand ethical issues specific to immunisation clinical trials  Understand how endpoints of immunisation clinical trials are determined, including surrogate markers  Define surrogate markers, and identify their limitations  Understand the immunological, microbiological and laboratory assessment of immunisation clinical trials  Understand principles of safety monitoring and post-licensure surveillance systems  Understand vaccine study design  Design a research proposal in immunisation
Assessment:	Two assignments, each of 2000 words, and each worth 50 per cent
Prescribed Texts:	nil
Recommended Texts:	Students will be provided with articles and references that support the teaching program as part of their course materials
Breadth Options:	This subject is not available as a breadth subject.
Fees Information:	Subject EFTSL, Level, Discipline & Census Date
Generic Skills:	Students who successfully complete this subject will be able to: Understand the basic principles of immunisation Understand the methods employed in the conduct of immunisation clinical trials Understand ethical issues specific to immunisation clinical trials Understand how endpoints of immunisation clinical trials are determined, including surrogate markers Define surrogate markers, and identify their limitations Understand the immunological, microbiological and laboratory assessment of immunisation clinical trials Understand principles of safety monitoring and post-licensure surveillance systems Understand vaccine study design Design a research proposal in immunisation
Links to further information:	http://www.mccp.unimelb.edu.au/courses/award-courses/graduate-diploma/clinical-research
Related Course(s):	Graduate Diploma in Clinical Research Master of Clinical Research Specialist Cert.Clinical Research (Immunisation & Infectious Diseases)

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