Sydney 17 - 18 June 2025
Melbourne 17 - 18 Sep 2025
This course is aimed at those in Sponsor roles in clinical trials that are not commercially sponsored and that must comply with Good Clinical Practice (GCP) and other supporting Australian Regulatory requirements. This would include those in Senior Management/Management roles overseeing clinical trials, those responsible for Sponsor Clinical Operations and Project Management. If you are responsible for management of 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. The course will also cover major changes to Sponsor responsibilities and the new section on Data Governance in ICH GCP revision 3.
It is recommended that participants have a reasonable level of experience in clinical trials to get maximum benefit from the course.
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.