Requirement for Good Clinical Practice (GCP) training in Metro North Hospital and Health Service

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. 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.

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. How to add a completed course date with evidence to your TMS account (health.qld.gov.au).

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 Metro North Research Office has compiled a short list of Transcelerate approved GCP Mutual Recognition GCP certification providers:

• 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. To access the course, visit Australian Clinical Trials Education Centre (A-CTEC) – Melbourne Academic Centre for Health (machaustralia.org) to create an account, then search for “GCP” once logged in.
• IQVIA – to request access to the IQVIA site, please send an email to MetroNorthResearch-ClinicalTrials@health.qld.gov
• Good Clinical Practice (ICH GCP) Training Course – Genesis Research Services ($10 charge for this certification)
• ICH Good Clinical Practice E6 (R2) • Global Health Training Centre (tghn.org) Global Health Network

The Transcelerate GCP Mutual Recognition (transcelerate-gcp-mutual-recognition.com) resources provides a list of certified GCP providers, however you will need search on the providers own site for GCP training.

Yes, if the GCP course completed is recognised by Transcelerate Biopharma Inc. This should be uploaded to your TMS site. How to add a completed course date with evidence to your TMS account (health.qld.gov.au).

Metro North Office of Research: MetroNorthResearch-ClinicalTrials@health.qld.gov.au