Good Clinical Practice and Applications

This subject has the following teaching availabilities in 2013:

Intensive mode

A minimum of 120 hours, including contact time, on-line modules, pre-reading and assignments.

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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/

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.

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.

There are three components to the assessment:
1. An in-class test following completion of the two day face-to face teaching component (25% of the total mark)
2. On-line assessment associated with the on-line Elective modules (25% of the total mark, and completed as modules are finished)
3. A 3000 word assignment due 4 weeks after the completion of the in-class and on-line Elective modules

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:
1. An in-class test following completion of the core GCP two day face-to face teaching component (25% of the total mark).
2. Successful completion of the ACRP certification program as a CTI, CRA or CRC (75% of the total mark)

The required text from the Association of Clinical Research Professionals (ACRP) is provided to each student in addition to course lecture materials

Students will be provided with articles and references that support the teaching program as part of their course materials

This subject is not available as a breadth subject.

• 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.