We have 6 GCP Facilitators in South Yorkshire at present and we deliver GCP training on a regular basis throughout the area.
These courses are designed to provide a basic introduction to Good Clinical Practice (GCP) and the EU Directives, UK Regulations and Research Governance Framework requirements covering clinical trials and other NIHR Portfolio studies conducted within the NHS. The sessions have a practical focus with the key aim being that participants know what to do to practice excellent GCP when they return to their workplace to ensure that the rights, safety and well-being of patients are always protected.
Expected Learning Outcomes
Following the course, participants will have a demonstrable understanding of the background and practical implications of GCP. This understanding is intended to be a foundation for action, enabling them to bridge the gap between theory and practice in their places of work. Participants will be able to:
- Demonstrate an understanding of the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
- Demonstrate an understanding of the roles and responsibilities of different individuals and organisations in clinical research
- Understand the regulatory applications required before a clinical trial can be started in the UK
- Identify a range of essential documents and the purpose of maintaining a trial master file
- Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process
- Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
- Demonstrate an awareness of the correct reporting requirements that ensure patient safety
- Know where to go for further advice and support and how to keep updated.
These courses are aimed at site staff involved in the conduct of studies once they have been accepted onto the NIHR Portfolio. Individuals involved in the design and management of portfolio studies are able to access these courses but should be aware that it will not address their specific needs.
These courses are available to all staff who are working on NIHR Portfolio Research.
|Introduction to GCP Courses 2014 ||GCP Refresher Courses 2014|
|7th January 2014 - Sheffield ||21st January 2014 - Sheffield|
|17th February 2014 - Rotherham ||10th February 2014 - Barnsley|
|19th March 2014 - RDASH ||6th May 2014 - Doncaster|
|1st April 2014 - Sheffield ||19th May 2014 - Sheffield|
|2nd June 2014 - Barnsley ||26th August 2014 - Sheffield|
|8th July 2014 - Sheffield ||11th September 2014 - Rotherham|
|15th September 2014 - Doncaster ||7th October 2014 - Sheffield|
|4th November 2014 - Sheffield ||11st December 2014 - RDASH|
Online GCP Training
The NIHR online GCP training is now available. You can request access via the Learning Managment System and once approved should be able to complete the training in approximately 4 hours.
The training works best in Internet Explorer.
Booking on to a GCP course
To secure a place on a GCP course or to access the online GCP training you need to register with the NIHR Learning Management System (LMS). All the information about the courses can be accessed via the LMS.
You can access the LMS at http://learning.nihr.ac.uk/learning/
The registration form is mostly straight forward but here is a little guidance for a few of the fields:
- Network/Organisation - Select the research network that you work for or "CCRN: Comprehensive Clinical Research Network"
- Local Network/Organisation - Select the specific local research network you work for or "CLRN: South Yorkshire"
- NHS Trust/Other organisation - Select the organisation you work for (e.g. Sheffield Children's Hospital)
- Portfolio Trial Acronym/title - If you are not already working on a trial then please enter "Research ready"
An LMS user guide can be found below to help you once you are logged in.
GCP example programme
LMS user guide