Study Design in Clinical Research

Subject CLRS90011 (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: 24 hours of lectures/seminars/workshops
Total Time Commitment: Students should expect to undertake a minimum of 120 hours of lectures, research, reading, writing etc 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: Clinical Research is a dynamic field of biomedical research activity tackling practical issues in the management and treatment of patients. This subject provides an overview that will equip a researcher with a broad appreciation of the many aspects of clinical research, from the ethical issues to the essentials of integrity and quality. It provides a thorough basic foundation in clinical research and the conceptual framework for more advanced study by filling out the terminology and underlying techniques used in clinical research settings.
Objectives: Students who successfully complete this subject will be able to:
Understand the basic principles involved in patient-oriented research
Understand the infrastructure needs to perform clinical research
Understand appropriate scientific conduct in clinical research
Be familiar with issues of safety and monitoring, both of subjects and data
Understand the role and issues of patient selection
Understand the phases of studies
Understand the issues involved in measurement of exposure and response
Assessment: One assignment of 4,000 words (100%). Students will be required to design a research study, specifying the infrastructure required, ethical issues that need to be addressed, safety monitoring that needs to be applied, how patients will be selected, and what measures will quantify exposure and response.
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 involved in patient-oriented research
Understand the infrastructure needs to perform clinical research
Understand appropriate scientific conduct in clinical research
Be familiar with issues of safety and monitoring, both of subjects and data
Understand the role and issues of patient selection
Understand the phases of studies
Understand the issues involved in measurement of exposure and response
Links to further information: http://www.mccp.unimelb.edu.au/courses/award-courses/graduate-certificate/clinical-research
Related Course(s): Graduate Certificate in Clinical Research
Graduate Diploma in Clinical Research
Master of Clinical Research
Professional Certificate in Clinical Research

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