Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.
Everyone involved in the conduct of clinical research must be competent to perform their tasks, qualified by education, training and experience.
This is a requirement of the Research Governance Framework for Health and Social Care 2005, the policy covering all research in the NHS in England, and in law (SI 2004/1031, Schedule 1, Part 2, 8) for those people working on clinical trials.
In order to be competent to perform their tasks, it is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.
To help Principal Investigators and others at clinical research sites determine who needs GCP training and to what level, we have developed the Delegation and Training Decision Aid. By thinking first about what tasks need to be delegated, you can then consider whether the people who will be carrying out those tasks have the training and experience they need.
We provide a range of training courses for people who need a full GCP course, and offer a range of materials for those who only need training in a specific aspect of GCP for delivery in research sites.
This is decided by your Trust/employer, as the answer depends on the research you are involved in, and your previous experience.
For clinical trials, the Medicines for Human Use (Clinical Trials) (2004) regulations require that all staff are trained to carry out their duties on each study they are working on. This is not time bound. If you have just had participated in training and a regulatory change is made, you will need to be informed of these changes and understand their implications for your practice.
We offer a range of high quality GCP training courses. All our GCP courses have a practical focus, with the key aim that participants know what to do to practise excellent GCP when they return to their workplace - to ensure the rights, safety and dignity of research participants and the quality of research data.
Our courses are designed for individuals involved in the conduct of studies at research sites. Although the people accessing our training may also have responsibility for elements of the study design or other activities associated with sponsorship, our training will not prepare them for these aspects of their role.
Our training is relevant to interventional studies of any kind, including Clinical Trials of Investigational Medicinal Products (CTIMPs), Clinical Investigations of Medical Devices, surgical studies and other kinds of interventional ‘non-CTIMP’. While much of the content of our courses is applicable to observational studies, the application of GCP to practice is not explored in this context.
The Clinical Research Network has delivered GCP training since 2009, and we launched our e-learning programmes in 2012. Since then, over 147,000 people have completed our GCP training. In the last financial year, April 2016 to March 2017, 30,318 individuals accessed the GCP course through e-learning. 97.8% of these learners said the e-learning was good or very good. During this period 6,826 people also accessed the course through face to face workshops provided by the Local Clinical Research Networks (LCRNs).
NIHR CRN GCP courses are available free of charge to the NHS, UK universities, and other publicly funded organisations conducting and supporting clinical research.
We are not able to provide access to non-UK researchers as the courses explore the application of GCP in the context of UK regulations, policies and frameworks. We are not able to provide details of alternative providers.
If you are not sure which course you need, find out more about the range of GCP courses we offer.