Melbourne 11 – 12 Oct 2022
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.
Datapharm Australia and Caledonian Clinical Training are offering two options for our Study Coordinator Introduction to Clinical Research training course for 2022, face-to-face and remote courses. The remote course allows those who would not readily be able to travel to attend. The agendas for both are available from Datapharm Australia on request. In summary, our course options this year will be:
- Two-day face-to-face in Brisbane and Melbourne
- Two-day remote
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.
- 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 1 week prior to course. Late applications considered.
Course Fee : face to face is $1100 & remote is $900 + GST
Please contact Julie Robinson at Datapharm Australia for further information.