What is GCP training?
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.
Why do you need GCP training?
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.
Does everyone need to complete the same GCP training?
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, the NIHR has 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.
The NIHR provides 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.
How often do you need to complete GCP training?
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.
What GCP training is available?
The NIHR offers a range of high quality GCP training courses. All 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.
NIHR courses are designed for individuals involved in the conduct of studies at research sites. Although the people accessing their training may also have responsibility for elements of the study design or other activities associated with sponsorship, training will not prepare them for these aspects of their role.
NIHR 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 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, they launched an e-learning programme in 2012. Since then, over 147,000 people have completed the NIHR 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.
Sadly they 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.
– I know what course I am looking for
If you know which course you would like to access, go straight to CRN Learn. If you haven’t used CRN Learn before, we suggest you read Getting started – essential information.
– I am not sure which course I should do
If you are not sure which course you need, find out more about the range of GCP courses the NIHR offers.
Thank you for the information! I’ve recently completed a GCP course which provided me with valuable information about the latest requirements of international regulatory bodies (MHRA, FDS and EMA).
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