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Which staff groups is this course for?
The following research training taking place at UHDB is available to all staff involved in research, free of charge.
A key requirement for anyone involved in the conduct of clinical research is GCP training. GCP is the ethical and practical standard to which all clinical research is conducted. Everyone involved in the conduct of clinical research must have this training to ensure they are best prepared to carry out their duties. This is laid down in the Research Governance Framework for Health and Social Care 2005, covering all research in the NHS in England, and in law for those people working on clinical trials.
The principles of GCP state that:
'Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). (2.8, E6 Guideline for Good Clinical Practice)'.
In addition, this course is designed to highlight the additional regulatory requirements applicable to Clinical Trials of Investigational Medicinal Products so is particularly relevant to those involved with this sub-set of trials.
Valid Informed Consent is targeted to those who have already completed their GCP course and deals with the ethical and legislative side of the consenting process.
The GCP course provides an intensive overview of the fundamentals of Good Clinical Practice, tailored for new or experienced staff. The training is based on the ICH GCP guidelines but also introduces The Medicines for Human Use (Clinical Trials) Regulations (as amended), which have transposed the EU Clinical Trials Directive and GCP Directive into UK law.
Every two years on both. However, this is decided by your Trust/employer, as the answer depends on the research you are involved in and your experience. The Medicines for Human Use (Clinical Trials) (2004) regulations, and the MHRA 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 some training and a regulation changes you will need to be informed of these changes
Half day NIHR GCP Refresher courses are planned to run at UHDB for those who did their full GCP Introduction course 2 years ago. The full GCP Introduction course is a full course for those who have never done the course before, or for those who have been out of research for much longer than 2 years.
You will need to set up an account, if you don’t already have one, by visiting the National Institute for Health Research (NIHR) Identity Gateway (opens in new window) >
If you are NIHR staff or you already have an account you can register to use CRN Learn using your NIHR Hub Account.
Go the login page and select ‘Sign-in with Google’ . When you have generated an account you will receive an email with Enrolment Key code. Once registered you must go into this email and confirm details. Also you will need to log into the registered account again to activate it.
Once all of the above has been completed you will have access to any of the dates available and be able to register.
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