Biomedical Research Management

Subject CLRS90015 (2011)

Note: This is an archived Handbook entry from 2011.

Credit Points: 25
Level: 9 (Graduate/Postgraduate)
Dates & Locations:

This subject has the following teaching availabilities in 2011:

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: 48 hours of lectures/seminars/workshops
Total Time Commitment: In addition to face-to-face teaching time of 48 hours, students should expect to undertake a minimum of 160 hours research, reading, writing and general study 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: mcccp.enquiries@mccp.unimelb.edu.au

Subject Overview:

Topics covered in this subject include:
Pricing of protocols
Funding models
Project planning and development
Project management
Regulatory and legal issues
Stakeholder management
Project implementation
Risk management
Business and business plan developmen
New frontiers in biomedical research management
Scientific Writing
Objectives: Students who successfully complete this subject will:
 Understand and be conversant with the major activities involved in planning clinical research projects from start to finish;
 Understand and be able to develop strategies to manage clinical research projects;
 Understand the nuances, rationales, politics, risks and benefits of dealing with a variety of project stakeholders;
 Understand the need to comply with regulatory requirements, the processes to fulfill this and be able to identify potential regulatory and legal pitfalls;
 Be able to prepare and operate a budget for clinical research projects and adapt the budget to changing circumstances;
 Understand what is required to develop a business plan for the commercial development of the outcomes of clinical research;
 Have the knowledge and tools for clinical research project implementation, including ongoing review, adaptation and risk management;
 Be aware of a variety of leading edge developments in the biomedical research field.
Assessment:

A 2 hour examination that assesses the learning from the course (20%), an assignment that prices a clinical research protocol and variations of a protocol according to a range of criteria (3,000 words) (30%) and a comprehensive implementation plan for a clinical research protocol that draws on the course contents in an integrated manner (5,000 words) (50%).

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:

Understand and be conversant with the major activities involved in planning clinical research projects from start to finish
Understand and be able to develop strategies to manage clinical research projects
Understand the nuances, rationales, politics, risks and benefits of dealing with a variety of project stakeholders
Understand the need to comply with regulatory requirements, the processes to fulfill this and be able to identify potential regulatory and legal pitfalls
Be able to prepare and operate a budget for clinical research projects and adapt the budget for changing circumstances.
Understand what is required to develop a business plan for the commercial development of the outcomes of clinical research
Have the knowledge and tools for clinical research project implementation, including ongoing review, adaptation and risk management
Be aware of a variety of leading edge developments in the biomedical research field

Links to further information: http://www.mccp.unimelb.edu.au/subjects/biomedical-research-management
Related Course(s): Graduate Diploma in Clinical Research
Master of Clinical Research

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