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 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 well-being of patients and the quality of the research data. All NIHR CRN GCP courses are appropriate for people conducting clinical trials, non-clinical trials and other kinds of research.
Our courses are designed for individuals involved in the conduct of studies at research sites. Individuals involved in the design and management of studies are able to access our courses but should be aware that they will not address their specific needs.
The Network has delivered GCP training since 2009, and we launched our e-learning programmes in 2012. Since then, over 109,000 people have completed our GCP training.
In the last financial year, April 2015 to March 2016, 24,917 individuals accessed the GCP course through e-learning. 97.6% of these learners said the e-learning was good or very good. During this period 7,035 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.