Note: This is an archived Handbook entry from 2010.
|Dates & Locations:|| |
This subject has the following teaching availabilities in 2010:Semester 1, Hawthorn - Taught on campus.
Semester 2, Hawthorn - Taught on campus.
Timetable can be viewed here. For information about these dates, click here.
|Time Commitment:||Contact Hours: A total of 28 hours |
Total Time Commitment: A minimum of 120 hours, including contact time, on-line modules, pre-reading and assignments.
|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/
Melbourne Consulting and Custom Programs
Level 3, 442 Auburn Rd
Hawthorn VIC 3122
Phone: 9810 3300
The subject contains a core module in Good Clinical Practice (taught in the classroom) plus a selective based on the needs of the student. Electives are undertaken on-line. Students will choose one elective from the following list:
The Electives are:
Topics covered in the core Good Clinical Practice module include:
Topics covered in Elective 1, Clinical Trial Conduct I, include:
Topics covered in Elective 2, Clinical Trial Conduct II, include:
Students who successfully complete the core GCP module of this subject will be able to:
Students who successfully complete Elective 1 of this subject will be able to:
Students who successfully complete Elective 2 of this subject will be able to:
There are three components to the assessment:
Alternately, students actively working in Clinical Research and who wish to obtain Association of Clinical Research Professional (ACRP) certification for Clinical Trial Investigator (CTI) or Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) may elect to undergo the following assessment:
|Prescribed Texts:||The required text from the Association of Clinical Research Professionals (ACRP) is provided to each student in addition to course lecture materials|
|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:|| Project management |
Understanding of the Australian regulatory environment for clinical research
Scientific / laboratory record keeping
Development, use and value of Standard Operating Procedures
Basic understanding of the phases and major steps in drug development
Understanding of the fundamental activities and responsibilities for researchers undertaking clinical studies in human volunteers.
|Links to further information:||http://www.mccp.unimelb.edu.au/subjects/good-clinical-practice|
Graduate Diploma in Clinical Research |
Master of Clinical Research
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