Requirement for Good Clinical Practice (GCP) training in Metro North Hospital and Health Service
From 1 September 2019, all Principal Investigators (PI’s) of clinical trials being conducted at Metro North must provide evidence of accredited GCP certification undertaken within the previous 3 years. Evidence of GCP certification will form 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 requirement applies to all new studies seeking SSA authorisation.
Frequently asked questions
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.
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.
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. The GCP guidelines, with the Therapeutic Goods Administration (TGA) clarifications can be found here https://www.tga.gov.au/publication/note-guidance-good-clinical-practice
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. From 1 September 2019, all site Principal Investigators (PIs) of clinical trials being conducted at Metro North must provide evidence of accredited GCP certification undertaken within the previous 3 years. 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 applies to new studies submitted after September 2019 and does not apply retrospectively to studies that have already been granted SSA authorisation prior to this date.
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 and submitted in hardcopy, if required by the RGO.
Throughout the year, the Metro North Office of Research coordinates face-to-face GCP courses for Metro North staff with an external GCP trainer at a competitive price. Dates for these courses can be found on the Metro North Research webpage. Other face-to-face GCP course options are also regularly offered by other bodies 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 Metro North Office of Research can provide a link to an online GCP course to Metro North staff. Other online GCP Courses are also offered by Praxis Australia and ARCS for a fee.
Yes, if the GCP course completed is recognised by Transcelerate Biopharma Inc.