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Postgraduate Handbook

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Advanced Clinical Trials Management - PHPH9116
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Campus: Kensington Campus
 
 
Career: Postgraduate
 
 
Units of Credit: 6
 
 
EFTSL: 0.12500 (more info)
 
 
Indicative Contact Hours per Week: 0
 
 
Fee Band: 3 (more info)
 
 
Further Information: See Class Timetable
 
  

Description

The focus of the advanced module will be the practical application of the underlying principles encountered in the core course on clinical trials management. Students will prepare a complete data package for the research ethics committee (REC) for a study submitted as part of the clinical trials notification (CTN) scheme as the major focus and assessment task for this module. The trial will be multi-centred and early phase, that is Phase II to III. There will be potential serious toxicities and a data safety monitoring committee will need to be established. Students will develop the clinical trials protocol, the draft patient consent form, and case report form (CRF). The application package will be assessed by a mock REC and the student will be asked to respond to questions and criticisms raised by the REC.

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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.