We provide Good Clinical Practice (GCP) training to staff delivering commercial research throughout the NHS in England, free of charge. This includes all staff working on clinical research in the NHS and providing NHS services to NHS patients.
Our training programme has been developed with the support of the Medicines and Healthcare products Regulatory Authority (MHRA). It is widely recognised by commercial companies as it is readily accessible across the whole of the NHS and sponsors are assured that it meets regulatory requirements. In addition, our GCP training has been added to the list of programmes mutually recognised by TransCelerate member companies.
What is Good Clinical Practice (GCP)?
The principles of ICH-GCP is an international standard for the conduct of clinical research. Undertaking clinical research in compliance with the principles of GCP provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.
What is TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a collaboration of global life-sciences industry companies which aims to find solutions to common issues facing pharmaceutical and biotechnology companies and further improve patient safety.
Ensuring that staff working on clinical research studies receive GCP training of a high standard in each of the countries that life science companies choose to place their research is one such issue. To tackle this, the TransCelerate member companies, (such as GSK, Pfizer, Roche), have developed guidelines for GCP training standards for research teams – including medical, nursing and clinical support staff delivering the clinical research studies.
What does TransCelerate BioPharma Inc recognition mean?
Our GCP training has been added to the list of programmes mutually recognised by TransCelerate member companies. This means that it meets the Minimum Criteria for GCP (see below) Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
In practical terms this means that, when a study is placed at a site in the NHS, if the Principal Investigator and the research team have completed GCP training provided by the NIHR Clinical Research Network, they will not be required to undertake further company-specific GCP training. This will help to streamline study set-up and allow research teams to focus on other important set-up activities such as pre-screening patients.
In 2014 our GCP training attracted attention outside of the UK and is was rolled out by the Peter MacCallum Cancer Centre, Australia’s only public hospital solely dedicated to cancer treatment, research and education. Sophie Mepham, Head of the Clinical Trials Unit at the Centre said:
“We realised that we had nothing like this programme in Australia. There is so much expertise within the Clinical Research Network and we were very keen to collaborate to embed this programme within our research culture. There was no need to re-invent or re-design it. It’s absolutely fit-for-purpose.”
“Using the GCP training model has made a significant change. Staff who have had the training have an enhanced understanding of the central importance of GCP. We have already used the programme to train 10% of our staff and are confident that this approach will ensure the ongoing high quality of clinical trials at Peter Mac.”