Advanced Clinical Trials Management - PHAR9116
Faculty: Faculty of Medicine
School: School of Medical Sciences
Course Outline: http://drugdev.med.unsw.edu.au/
Campus: Sydney
Career: Postgraduate
Units of Credit: 6
EFTSL: 0.12500 (more info)
Indicative Contact Hours per Week: 0
CSS Contribution Charge: 3 (more info)
Tuition Fee: See Tuition Fee Schedule
Further Information: See Class Timetable
View course information for previous years.
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.
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.
Study Levels
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