Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible.

Refer to: https://www.australianclinicaltrials.gov.au/researchers/good-clinical-practice

Good Clinical Practice (GCP) Training Requirements for Trial and Other Staff - (as detailed in Section 3.4, page 29 of the National Standard Operating Procedures for Clinical Trials document)

In accordance with the Clinical Trials Governance Framework, it is essential that clinical trial Investigators and clinical trial staff with significant delegated trial related responsibilities have access to and undertake training in the principles of GCP as a minimum requirement. Knowledge of GCP should be provided in a way that is proportionate to the individual’s role and level of trial activity. A trial risk assessment can be used to inform and justify the level of training, however the following minimum requirements apply:

Staff with significant trial related duties (all trials) (Mandatory, also refer to next section):

• Core trial staff should receive TransCelerate accredited GCP training. Refresher GCP training should also be available to trial staff, at appropriate intervals (every three years) to ensure that staff maintain awareness of current clinical trial standards and legislation.

Ancillary staff involved in trials with novel/non-routine interventions:

• For staff conducting trial related procedures or involved in the care of trial patients/participants, GCPtraining may be in an abbreviated format; for example, taking the form of a short departmental trial awareness sessions covering relevant requirements such as:

– recording adverse events.

– documenting activities in source notes.

– notifying Protocol deviations and adverse events to the core trial team.

– escalating any other issues identified to the core trial team.

 Staff provided abbreviated GCP training include:

• pharmacy staff involved in general dispensing, under the oversight of a trial pharmacist who may perform training on relevant trial/GCP requirements.
• laboratory/diagnostic staff undertaking routine tests used in a trial, under the oversight of a lead contact who may perform training on relevant trial/GCP requirements.
• chemotherapy nurses with only the role of administering Investigational Products under the oversight of a day ward manager who has undertaken relevant GCP training.
• ward or other staff performing routine activities within their scope of practice.

Ancillary staff involved in standard care trials:

• Trials involving routine treatment (e.g. comparative effectiveness trials) often involve large numbers of healthcare professionals that are suitably qualified to undertake the trial by virtue of the prior education, training and experience, and work to quality systems outlined in their professional codes of practice. Consistent with the Clinical Trials Governance Framework, at a minimum, all trial staff should be made aware of the trial/relevant GCP principles (e.g. at routine meetings, short trial awareness sessions or provision of written materials).

Mandatory GCP Training requirements for Clinical Trials:

• Proof of current GCP training is required for all Principal Investigators for sites under the jurisdiction of the SLHD HREC (RPAH & CRGH Zone)
• Proof of current GCP training is required for ALL study site team members named in an STE/SSA application for all SLHD sites (RPAH, Concord, Canterbury, Balmain, Sydney Dental Hospital and other SLHD specific sites)
• Please submit GCP certificates of completion with HREC/SSA submission in REGIS
• Note that GCP certificates must be renewed every 3 years
• The GCP course can be completed via the following link: https://globalhealthtrainingcentre.tghn.org/ich-good-clinical-practice/
• SLHD Researchers can access free face-to-face GCP training. Refer to the “Upcoming Events & Training Opportunities” on the SLHD Research Intranet page: http://slhd-intranet.sswahs.nsw.gov.au/research/Training.html 

Useful Clinical Trials links:

Clinical Trials Accreditation and Audit (only accessible via SLHD Research Intranet)

NSW Health Clinical Trial Toolkit

ICH Guideline for Good Clinical Practice

Australian Clinical Trial Handbook (TGA)

The Australian Code for the Responsible Conduct of Research, 2018 (the 2018 Code)

National Standard Operating Procedures for Clinical Trials

National Principles for Teletrials in Australia

TGA Good Clinical Practice Inspection Program (GCPIP)

Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the Good Clinical Practice (GCP) Inspection Program.  The TGA inspects Australian clinical trial investigator sites of clinical trials for medicines and biologicals to assess whether they are meeting their GCP responsibilities.

Refer to: Good Clinical Practice (GCP) inspection program | Therapeutic Goods Administration (TGA)

You should ensure you have appropriate processes in place to allow for the identification, retrieval and management of all documentation relating to clinical-trial-related activities as the TGA inspectors may ask to evaluate this documentation during the inspection process.

Your inspection-related responsibilities include, but are not limited to:

•           ensuring your clinical trials are conducted in compliance with Australian regulations and the relevant GCP guideline(s)

•           maintaining your readiness for inspection, as inspections may be unannounced

•           providing the inspectors, within the given deadline, with any information or documentation they need to prepare or conduct the inspection

•           ensuring staff involved in the clinical trial are available (in person or remotely) during the inspection for interview or to clarify issues

•           preparation and implementation of appropriate and timely corrective and preventative action (CAPA) plans to address the inspection’s findings and prioritise any critical or major deficiencies.