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Good Clinical Practice (GCP)

Which staff groups is this course for?

The following course is available to all Derby Teaching Hospitals NHS Foundation Trust staff involved in research, free of charge.

A key requirement for anyone involved in the conduct of clinical research is Good Clinical Practice (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 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.

Course summary

These courses provide 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

Compliance frequency

Every 2 years

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

Derby Course details

Two half day NIHR GCP refresher courses are planned to run at DHFT for those who did their full GCP course 2 years ago.  Details of 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 will be uploaded onto this site as soon as they are available. 

Details, dates, times & location:

Workshop

Date of session

Timings

Venue

GCP Introduction

24/01/2018

09.15 to 16.30

 Room 306  - Level 3 - School of Health Sciences

GCP Refresher

08/03/2018

09:15 to 12:30

 Clinical Skills Room 4  - Education Centre, Level 4

GCP Refresher

07/06/2018

09:15 to 12:30

Clinical Skills Room 1  -  Education Centre, Level 4

GCP Introduction

11/07/2018

09:15 to 16:30

Clinical Skills Room 1 - -  Education Centre, Level 4

GCP Refresher

11/09/2018

 09.15 to 12.30

Room 306  - Level 3 - School of Health Sciences

GCP Refresher

05/12/2018

09:15 to 12:30

Clinical Skills Room 4   -  Education Centre, Level 4 


To register onto the course please follow registration instructions below:
You will need to set up an account, if you don’t already have one, by registering at CRN: Learn
If you are NIHR staff or you already have an account you can register to use CRN Learn using your
NIHR Hub Account. Click ‘Sign-in with Google’ at the following link: http://learn.nihr.ac.uk/login/index.php
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.
 
If you are having problems it could be that you need to download Google or Firefox as your browser. For any technical issues you would have to contact the help desk on 0207 333 5894.
 
Any queries regarding registration please contact crnemlearn@nihr.ac.uk