From 1 September 2019, all Principal Investigators (PI’s) of clinical trials being conducted at Metro North must have provided evidence of an accredited GCP certification undertaken within the previous 3 years.
Evidence of GCP certification is a requirement for Site-Specific Assessment (SSA) authorisation. The site PI is then responsible for ensuring respective members of the research team undertake GCP training prior to the commencement of the study. This applies to all new studies within Metro North Health.
What GCP course options exist for Metro North employees?
There are no face-to-face GCP courses presently offered by Metro North Health. If a face-to face course is preferred, they are regularly offered by external parties including ARCS and Datapharm Australia (these are external to Metro North). While face-to-face GCP education is highly recommended, completion of an online GCP course is also acceptable. The Australian Clinical Trials Education Centre (A-CTEC) Australian Clinical Trials Education Centre (myopenlms.net) has released an online GCP course that is relevant to the Australian clinical trials setting. All training offered through A-CTEC is free and requires registration to the training site. A Transcelerate Biopharma Inc approved certificate of completion is provided once the training has been completed.
Facilitators
ARCS Australia
ARCS Australia is a national, membership-based organisation focused on the development and growth of the healthcare sector. ARCS provides education, career pathways, professional development and advocacy to the healthcare sector.
Australian Clinical Trials Education Centre (A-CTEC)
A-CTEC is a not-for-profit, Australia-wide education centre, with a dedicated Learning Management System (LMS) hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs. A-CTEC was originally developed in Victoria and expanded nationally in early 2023.
What is Good Clinical Practice (GCP)
The guideline for Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve human participants. It relates specifically to research and should not be confused with clinicians generally applying good clinical practice in the care of their patients.
What is the purpose of GCP?
Adherence to GCP serves as a best-practice standard for all clinical trials to protect the rights, safety and well-being of participants and provides assurance that the clinical trial data are credible. As GCP is an international standard, it facilitates mutual acceptance of data from clinical trials by regulatory authorities.
What does GCP specify?
The GCP guideline details and delineates the respective responsibilities of those involved in the conduct of clinical trials. It also specifies requirements, including those related to participant consent, protocol and associated amendments, the investigational product, essential documentation, safety reporting and quality management. GCP provides best-practice processes, many of which can be applied to all types of research, not just clinical trials.
View the GCP guidelines, with the Therapeutic Goods Administration (TGA) clarifications.
What are the GCP training requirements in Metro North?
All clinical trials being conducted in Metro North should adhere to the GCP principles. Clinical trials comprise not just pharmaceutical trials, but any research investigations involving human participants to test new treatments, interventions or tests. For those clinical trials involving an unapproved drug or device to adhere to GCP guidelines, there is a legal requirement for the trial to be conducted according to GCP. All site Principal Investigators (PIs) of clinical trials being conducted at Metro North must provide evidence of current and accredited GCP certification undertaken. The site PI is then responsible for ensuring respective members of the research team undertake GCP training prior to the commencement of the study. This requirement has been applied to studies submitted after September 2019.
When do I have to provide evidence of GCP training?
Evidence of completion of a GCP training course recognised by TransCelerate Biopharma Inc must be submitted to the relevant Metro North Research Governance Officer (RGO) with the Site-Specific Assessment (SSA) application. TransCelerate Biopharma Inc is a global group comprising representatives from leading pharmaceutical companies that provides minimal criteria for GCP courses and provides a framework for mutual recognition of GCP training by pharmaceutical Sponsors. The certificate should be uploaded to ERM with your SSA and for Metro North Health staff, to your own TMS site.
Find out how to add a completed course date with evidence to your TMS account.
Can I provide evidence of completing a different GCP course?
Yes, if the GCP course completed is recognised by Transcelerate Biopharma Inc. This should be uploaded to your TMS site.
Find out how to add a completed course date with evidence to your TMS account.
Contact Us
Contact the Metro North Office of Research for more information on the requirement.