UNSW Handbook Course - Advanced Clinical Trials Management

Advanced Clinical Trials Management - PHAR9116


	Faculty: Faculty of Medicine
	School: School of Medical Sciences
	Course Outline: http://drugdev.med.unsw.edu.au/
	Campus: Kensington Campus
	Career: Postgraduate
	Units of Credit: 6
	EFTSL: 0.12500 (more info)
	Indicative Contact Hours per Week: 0
	CSS Contribution Charge:Band 3 (more info)
	Tuition Fee:See Tuition Fee Schedule
	Further Information: See Class Timetable

Description

PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9116.

The focus of the advanced module is to learn how to manage a clinical trial by using a specific example of a study in a selected therapeutic area. The course builds on knowledge gained, in particular, from PHAR9120 including the critical appraisal skills that have been emphasised as a key competency for any individual involved in the development and regulation of medicines and devices. It is not the intention that the course is a ‘project management’ course per se. The aim, rather, is to provide students with a good, practical understanding of clinical research and trials.

The course covers how to plan a clinical trial to meet designated timelines and within budgetary constraints; how to further understanding of the putative mechanisms of action of the therapeutic agent being investigated, and of the clinical area and the endpoints that are important for studies in that area. An important component of the course involves critical appraisal of a study in the selected therapeutic area and writing the synopsis for the study report. Preparation of a consent form for submission to a Human Research Ethics Committee (HREC), pages for a Case Record Form (CRF) and a study budget are exercises undertaken in the course. The weekend school provides interactive practical examples and reviews of the assignment work.

Note: This course is elective for Programme 9060.

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© The University of New South Wales (CRICOS Provider No.: 00098G), 2004-2011. The information contained in this Handbook is indicative only. While every effort is made to keep this information up-to-date, the University reserves the right to discontinue or vary arrangements, programs and courses at any time without notice and at its discretion. While the University will try to avoid or minimise any inconvenience, changes may also be made to programs, courses and staff after enrolment. The University may also set limits on the number of students in a course.