Sydney - 4th & 5th June 2024
This course is aimed at those conducting clinical trials that are not commercially sponsored and that must comply with Good Clinical Practice and other supporting Australian Regulatory requirements. For example if you are responsible for investigator-initiated trials, University sponsored trials, collaborative research group trials, or you run trials from a Medical Institute then this course will provide a practical overview of critical sponsor GCP responsibilities.
Course topics will include sponsor quality management, setting up and maintaining sponsor standard operating procedures, elements that are critical to quality in protocol development, data management and statistical requirements, risk-based monitoring of trials and other key sponsor responsibilities including safety management and reporting and Trial Master File maintenance. It is recommended that participants have at least three months experience in clinical trials as a minimum.
Register Here
Payment Details
Closing date 1 week prior to course. Late applications considered.
Course Fee : $1200 + GST
Please contact Julie Robinson at Datapharm Australia for further information.
julie.robinson@datapharmaustralia.com
(02) 9719-2800
Eleanor Allan
The trainer, Eleanor Allan, has over 20 years’ experience in training clinical research personnel and is passionate, enthusiastic and practical in her approach. She trains Study Coordinators, Principal Investigators, academic researchers and sponsor personnel so understands the perspective of all parties. She is also an experienced clinical trials auditor and has first-hand knowledge of the current issues facing site personnel. The course will be interactive and include plenty of time for questions and discussions.