Good Clinical Practice (GCP)
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.
This subject is offered in partnership with The Nucleus Network and the Association of Clinical Research Professionals.
Subject Code
CLRS90008
Credit Points
12.5 points
Objectives
Students who successfully complete this subject will be able to:
- Review the evolution of Good Clinical Practice from its origins to currently acceptable standards and the imperative of keeping abreast of changing practices and regulations
- Define the major steps and phases of the drug development process
- Describe the main regulations governing the practice of clinical research and other applicable guidelines, including the EU Directive, Food and Drug Administration (FDA), Code of Federal Regulations (CFR), Data Privacy/Health Insurance Portability and Accountability Act (HIPAA), and International Conference on Harmonization (ICH)
- Examine the legal, professional and ethical constrains on various clinical research processes, such as the management of informed consent, Institutional Review Board (IRB) or Independent Ethics Committee (IEC) applications, disclosure of financial interests and electronic signatures
- Identify the tools and techniques for successfully managing and executing trials
- Analyse the international principles of ethical conduct and subject protection together with examples of acceptable and non-acceptable norms.
- Be conversant with the development of standard operating procedures.
Topics covered by Subject
Topics covered will include: Basic ethics in human research, principles of respect, autonomy, beneficence and malfescience, balancing harm and benefit, balancing the role of physician and researcher, the convergence of statistical and clinical reasoning in research, difficulties in various types of trial and case studies of high-profile mistakes and problems in studies, the need for integrity in trials and studies, principles of recruitment, selection, allocation and randomisation, the role of blinding and the need for objectivity, measurement of exposure and response, including surrogate measures, markers of response, and choice of endpoints.
Pre-requisites and/or Co-requisites
An undergraduate degree or equivalent qualification in medicine, an allied health profession, science or
social science which is recognised by the University as evidence of adequate preparation for the course
plus documented evidence of at least the equivalent of one year¿s full-time relevant professional work
experience in a medical, scientific or allied health environment.
All students will be required to meet the English Language requirements of the University.
Mode of Delivery
Intensive 4 day blocks
Contact Time
Eighteen hours of lectures/seminars/workshops in addition to eight hours of pre- and post-course reading. 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.
Assessment
Pre- & Post-test worth 50 per cent plus a selection of assignments, in total 3000 words, worth 50 per cent.
Subject Coordinator
Dr Robyn Lichter
Venue
TBC
Dates
2012 dates - please select one of the following dates:
March 13 -14
May 3 - 4 (last session to run)
Plus online learning
Course Fee
Subject cost is $2,350.
Prescribed Textbook
The required text from the Association of Clinical Research Professionals (ACRP) is provided to each student in addition to course lecture materials.
For further information contact
Mary Georges (03) 9810 3185 or email m.georges@commercial.unimelb.edu.au
Application Process
Applications are managed by Student Services.