Brisbane 25th-26th August 2026
Sydney 15th-16th September 2026
Melbourne 10th-11th November 2026
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP (R3) Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
Datapharm Australia, in collaboration with Caledonian Clinical Training will be presenting the two day Study Coordinator Introduction to Clinical Research training course on the above dates in 2026.
This interactive, in-person course is designed to provide study coordinators with a strong foundation in clinical research, combining practical insights with expert instruction in a supportive learning environment. Participants will benefit from real-world examples, opportunities for discussion, and direct engagement with an experienced trainer.
The agenda is available from Datapharm Australia on request.
This course is aimed at relatively new Study Coordinators; however it is recommended that participants have at least 3 months on-the-job experience prior to attending the training. This helps facilitate understanding of the more in-depth aspects of the course as participants will have direct experience of the concepts, documents and systems discussed in the course. It can be overwhelming when you first start and this two-day course gives you both a broad overview of clinical research activities and regulations, as well as more in-depth information on key Study Coordinator responsibilities. The course covers the Revision 3 version of GCP, which was adopted by the TGA in January 2026 and must be fully implemented by January 2027.
You will learn about the essential activities that contribute to a successful clinical trial including Good Clinical Practice and applicable local Australian clinical trial regulations and guidance, ethics, informed consent, clinical trial planning, managing essential records, quality in clinical trials, data collection (particularly source data), data governance, and managing adverse event reporting. You will understand what you have to do and how to interpret the particular requirements of Good Clinical Practice and other relevant regulations. It is not enough just to be doing activities; it is critical to understand why you are doing them. This helps you to develop processes and practical approaches that are efficient and ensure compliance with regulatory requirements.
Modules covered:
- Overview of Australian clinical trial regulations
- GCP & GCP responsibilities
- Ethics in clinical trials
- Informed consent
- Quality in clinical trials
- Clinical trial management
- Data collection and data governance
- Safety assessments in clinical trials
Register Here
Payment Details
Closing date 1 week prior to course. Late applications considered.
Course Fee: $1250 + 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.