units

TRM6001

Faculty of Medicine, Nursing and Health Sciences

Postgraduate - Unit

This unit entry is for students who completed this unit in 2015 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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0 points, SCA Band 3, 0.000 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.

LevelPostgraduate
FacultyFaculty of Medicine, Nursing and Health Sciences
OfferedAlfred Hospital First semester 2015 (Off-campus block of classes)
Monash Medical Centre Second semester 2015 (Off-campus block of classes)
Coordinator(s)Dr Steven Petratos

Synopsis

Successful clinical research is conducted under the guise of a well-constructed study question that is feasible, interesting, novel, ethical and relevant. A study design must be conceived with appropriate measures of clinical observation and intervention. This unit will establish a fundamental knowledge in drug development, conducting Clinical Trial studies, designing a good protocol, international conference on harmonisation good clinical practice (ICH-GCP) and delegation of responsibility and co-ordination. The unit provides instruction in the development of a clinical research question and creating a concise protocol that includes literature review, study design, subject sampling and recruitment, instruments and other measurement approaches, sample size, consent form, budget and timetable. The aim of the unit is to introduce students to the processes and regulations involved in developing a therapeutic through to clinical trials. Students completing this unit should be able to construct a testable clinical research question and design a protocol that is ethical, well controlled and statistically powerful. Students should also be able to identify the roles of the sponsor, the investigator, the institutional review board/ independent ethics committee and the local regulators.

Outcomes

Upon successful completion of this unit, students should be able to:

  1. Design a clinically relevant question and set of experiments.
  2. Outline Good Clinical Practice as followed by the international Conference on Harmonisation.
  3. Identify and describe the key steps in conducting a Clinical Trial including different types of human research and protocols that can be implemented.
  4. Identify and describe the key steps in the drug discovery process including identification of drug targets, Australian regulatory requirements, manufacture, development of a safety profile, clinical development and marketing.
  5. Outline how to manage regulatory documents.
  6. Outline the role of the Sponsor, the investigator, the institutional review board/ independent ethics committee and the local regulators.

Assessment

Essay 1 (1,500 words) (20%)
Essay 2 (1,500 words) (20%)
4 x Online self-directed learning tasks (5% each) (20%)
Online test (20%)
Media release about research (500 words) (20%)

Workload requirements

On-campus: This unit will be delivered as an intensive 1 week program with a total of 24 hours of face-to-face teaching, including lecture and tutorial workshop time. The remaining 10 hours per week (Over 12 week period) is made up of private study time completing on-line exercises, modules and 2 assignments to be submitted at the end of semester.

See also Unit timetable information

Chief examiner(s)

Co-requisites