The principles of ICH-GCP is an international standard for the conduct of clinical research. Undertaking clinical research in compliance with these principles 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.
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, with the goal of delivering more high quality medicines to patients.
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 members, (which includes companies such as GSK, Pfizer and Roche), have developed guidelines for GCP training standards for research teams - those medical, nursing and clinical support staff delivering the clinical research studies.
Training providers meeting the GCP criteria set out in the guidelines are added to a list of mutually recognised providers. The Clinical Research Network has recently been added to this list. Now, 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 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.
NIHR Clinical Research Network’s Head of Industry Operations, Lydia Christopher, commented on the news:
“Patient safety and high quality, robust clinical research is paramount and the Clinical Research Network’s GCP training courses are designed to ensure research teams fully understand their responsibilities and are rigorously trained in the principles of ICH GCP. Becoming a recognised provider is great news for the Clinical Research Network and demonstrates the increasing global presence of the Clinical Research Network and recognition of its achievements as a world class clinical research delivery organisation.”
Almost 23,000 healthcare professionals undertook the NIHR Clinical Research Network’s GCP programme in 2013/14. 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.
Find out more about NIHR Clinical Research Network GCP training:
Visit the TransCelerate BioPharma Inc. website.
Notes to editors:
The Clinical Research Network is part of the National Institute for Health Research.
We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part.
This practical support includes:
- Reducing the “red-tape” around setting up a study
- Enhancing NHS resources, by funding the people and facilities needed to carry out research “on the ground”
- Helping researchers to identify suitable NHS sites, and recruit patients to take part in research studies
- Advising researchers on how to make their study “work” in the NHS environment