Introduction to Clinical Research Course
Brisbane 19 – 20 March 2018
Melbourne 7 – 8 May 2018
Sydney 4 – 5 June 2018
Adelaide 6 – 7 Aug 2018
Brisbane 3 – 4 September 2018
Melbourne 29 – 30 October 2018
Sydney 19 – 20 Nov 2018
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
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. You will learn about the essential activities that contribute to a successful clinical trial including Good Clinical Practice, ethics, informed consent, clinical trial planning, managing essential documents, quality in clinical trials, data collection (particularly source documentation) 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.
The trainer, Eleanor Allan, has over 19 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.
- The drug development process & overview of Australian clinical trial regulations
- GCP & GCP responsibilities
- Ethics in clinical trials
- Informed consent
- Quality in clinical trials
- Clinical trial management
- Data collection & trial management
- Safety assessments in clinical trials
Closing date 2 weeks prior to course. Late applications considered.
Course Fee : $990 (inc GST)
Please contact Julie Robinson at Datapharm Australia for further information.