Course and dates

Good Clinical Practice (GCP) and Valid Informed Consent

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.

GCP Course summary

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.

Compliance frequency

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

Derby Course details

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.

Valid Informed Consent Training on 10/04/2019 may only have limited places remaining.  Before booking, please contact Vanessa to enquire about availability for this session.  Normal booking process via CRN Learn - Register an account for the October session.

Training dates

Training Dates at UHDB

Workshop

Date of session

Timings

Venue

GCP Refresher

07/03/19

09.15 to 12.30

Seminar Room - M&G Level 2, RDH

Valid Informed Consent

10/04/19

09:15 to 12:30

Seminar Room - M&G Level 2, RDH

GCP Refresher

24/06/19

09:15 to 12:30

Clinical Skills Room 4  - Education Centre, Level 4, RDH

GCP Introduction

04/07/19

09:15 to 16:30

Clinical Skills Room 1  -  Education Centre, Level 4, RDH

GCP Refresher

18/09/19

09:15 to 12:30 

Clinical Skills Room 4 - Education Centre, Level 4, RDH  

Valid Informed Consent

08/10/19

09:15 to 12:30

Seminar Room - M&G Level 2, RDH

GCP Introduction

02/12/19

 09.15 to 16.30

Clinical Skills Room 4   -  Education Centre, Level 4, RDH

How to register

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.

Go the NIHR 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.

If you are having problems it could be that you need to download Google or Firefox as your browser.

For any technical issues please telephone 0207 333 5894

For any queries regarding registration please contact crnemlearn@nihr.ac.uk.