Good Clinical Practice (GCP)
Everyone involved in the conduct of clinical research must have training in Good Clinical Research 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 tasks (s). 2.8, E6 Guideline for Good Clinical Practice?
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 experience. Within Gloucestershire the requirement is to undertaken GCP training every 3 years.
The 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.
COURSES AVAILABLE
Courses are available either through the Western Comprehensive Clinical Research Network or ourselves, see details below.
WCLRN – WESTERN COMPREHENSIVE CLINICAL RESEARCH NETWORK
The Western Comprehensive Clinical Research Network (WCLRN) is one of 25 CLRNs across England which form part of the NIHR Comprehensive Clinical Research Network (CCRN). The CCRN provides support for clinical trials and other well designed studies in all areas of disease and clinical need.
They provide training on GCP. Attendance is free to NIHR-funded staff, but please note that as these sessions are expensive to run, a fee of £75 will be charged to employing Trusts if a booking is made and the place is not taken up without good reason and due notice.
Download a copy of the Western CLRN Training Programme
RSS – RESEARCH SUPPORT SERVICE
Gloucestershire Research Support Service has put together a training programme for all Gloucestershire NHS employees involved in research, who require GCP training. Anyone who is in Clinical Trials of an Investigational Medicinal Product (CTiMP) must undertake GCP training and other researchers should attend too.
GCP Induction Sessions
The team will be holding the following session(s):
Date
|
Time
|
Venue
|
July 22, 2013
|
09:00am - 16:00pm
|
Room 9, Sandford Education Centre
|
September 30, 2013
|
09:00am - 16:00pm
|
Room F9, Redwood Education Centre
|
If you are able to attend one of these session, please complete the booking form or contact Gemma Race, Commercial Trial Facilitator via:
Tel: 0300 422 5464 or Email:
If these dates are unsuitable, please contact Gemma, so that we can compile a list of those who require training and look into organising future sessions.
Attendance is free, but please note that as these session are expensive to run, a small fee may be charged to cover administrative costs, if a booking is made and the place is not taken up without good reason and due notice.
GCP Refresher Sessions
Currently it is a countywide policy to have an update every 3 years.
The team will be holding the following session(s):
Date
|
Time
|
Venue
|
May 24, 2013
|
09:00am - 12:00noon
|
Room F7, Redwood Education Centre
|
September 13, 2013
|
09:00am - 12:00noon
|
Room 9, Sandford Education Centre
|
If you are able to attend one of these session, please complete the booking form or contact Gemma Race, Commercial Trial Facilitator via:
Tel: 0300 422 5464 or Email:
Attendance is free, but please not that as these session are expensive to run, a small fee may be charged to cover administrative costs, if a booking is made and the place is not taken up without good reason and due notice.