PSP025: NIHR RDN Good Clinical Practice Programme

This POF Support Page provides additional advice and information to enable Regional Research Delivery Networks (RRDNs) to fulfil the contractual obligations relating to the Workforce, Learning and Organisational Development requirements as specified within the NIHR Research Delivery Network (RDN) Performance and Operating Framework (POF).

Good Clinical Practice (GCP) is the international standard for the conduct of high quality clinical research. The National Institute for Health and Care Research (NIHR) Research Delivery Network (RDN) undertakes to provide appropriate training to all research delivery staff conducting NIHR RDN Portfolio studies through the provision of high quality and proportionate learning opportunities.

This commitment is met by an ‘in-house’ NIHR programme that is focused on the elements of GCP which are delivered by research delivery staff. This approach provides a cost effective solution to increasing demand and is highly valued by our partners and stakeholders. The programme is supported by key stakeholders including the Medicines and Healthcare products Regulatory Agency (MHRA) as providing high quality and relevant learning that has contributed to improvements in practice.

There are two interdependent elements to the NIHR RDN GCP programme:

• A suite of courses and resources designed to support high quality, proportionate learning for research delivery staff

• The GCP Facilitator Development Programme (FDP), through which facilitators are prepared to deliver GCP courses and input into the ongoing delivery and development of the whole programme.

The resources, standardised workshop materials and e-learning courses belong to the NIHR RDN and are valuable proprietary assets.

All GCP courses are part of the directory of national learning assets and as such RRDNs are required to follow the naming conventions as set out by the NIHR Learn community.

NIHR RDN Good Clinical Practice (GCP) courses should be made available to all research delivery staff conducting NIHR RDN Portfolio studies with freedom to act. The balance of online and face-to-face training used to meet this need in each RRDN may be different, and RRDN programmes should be planned with local priorities and resources in mind. Informed Consent and Principal Investigator training should be provided to research delivery staff as required.

The suite of NIHR RDN GCP courses and related resources are provided online via e-learning at a national level. Facilitator-led face-to-face and/or virtual-based learning can also be provided by RRDNs as GCP Introduction Consolidation Workshops.

Face to face delivery offers opportunities for partnership working with local organisations and engagement with the research delivery workforce. However resources to support this approach are finite and should be targeted.

NIHR GCP Facilitators Consolidation sessions (virtual or delivered face-to-face) are not mandatory and should be delivered with local priorities and resources taken into account.  They should however only be offered when research delivery staff have completed the national NIHR RDN  ‘Introduction to GCP’ e-learning course. GCP Programme Leads should feel confident that facilitators supporting these sessions in each RRDN are confident and competent in their ability to lead the session.

NIHR RDN GCP courses must be made available to all research delivery staff conducting NIHR RDN Portfolio studies with freedom to act: 

• there is no requirement to restrict participation to only those individuals working on NIHR RDN Portfolio studies, as the programme is intended to build capacity for effective research delivery and enhance the UK’s attractiveness as a place to conduct high-quality clinical research;

• the expectation is that demand is met through our existing model and that there is a proactive approach that will maintain a sustainable model in each RRDN: 

  • the current provision is available across the NIHR RDN, using a combination of classroom-based workshops, and proportionate virtual and e-learning courses according to local needs and requirements; 

  • while NHS trusts are able to make independent decisions to employ non-NIHR RDN providers to deliver GCP, NIHR RDN funds cannot be used for this purpose.

Each RRDN is required to employ a GCP Programme Lead; a suitably qualified individual responsible for strategic oversight of GCP education across their RRDN. GCP Programme Leads have a key role in promoting appropriate (proportional) use of GCP training, maintaining the quality of the local (face-to-face and virtual) programmes and playing an important role in the continuing development of the education suite. To enable GCP Programme Leads to fulfil their role effectively, particularly those aspects focused on quality and supporting facilitators to deliver the materials effectively, we recommend they are experienced and active facilitators.

GCP Programme Leads are expected to ensure that:

• facilitators are enabled and supported to deliver the workshop to the defined standards of the programme;

  • established facilitators are supported in preparing to deliver updated materials effectively; 

  • competence of new facilitators is assessed and, if appropriate, completion of the Facilitator Development Programme (FDP) is confirmed by completion of the facilitator agreement; 

  • where programme standards are not being achieved and support provided has not resulted in improvements, facilitators are removed from the programme. 

• facilitators are scheduled to deliver instructor-based workshops according to demand and local priorities, as agreed with the RRDN Workforce and People Senior Manager and / or RRDN Operations Director; 

• experience has shown that regular delivery is required in order to have confidence with materials and develop facilitation skills. GCP Programme Lead should take appropriate steps to ensure quality of delivery is maintained;   

• facilitators who take a break from facilitating (due to sickness, maternity leave or workload pressures, for example) are supported to meet the quality requirements as appropriate for each individual when they return to the programme; 

• RDNCC are informed in writing of any facilitator’s intention to stop facilitating NIHR RDN GCP workshops or their removal from the programme; 

• workshop participants will be registered on NIHR Learn, the NIHR RDN Learning Management System (LMS). 

Facilitator-led GCP courses run by a RRDN must be delivered by facilitators who have completed the national NIHR RDN GCP Facilitator Development Programme (FDP) either through attending the FDP course or by support by an experienced GCP mentor. Co-facilitation by a trained facilitator and a subject matter expert in paediatric research, for example, is acceptable providing the trained facilitator leads the workshop and is present throughout the entire workshop. Continued authorisation for individual facilitators to deliver NIHR RDN GCP workshops is dependent upon their successful delivery and participation in quality assurance processes.

GCP Programme Leads play a key role in the identification and support of new GCP facilitators, ensuring they are able to meet the specified requirements of this role. As the new facilitator will be joining the RRDN’s GCP delivery team, the decision about whether their application should be supported lies solely with them.  Consideration must also be given to the overall volume of face-to-face GCP training planned by the RRDN.

Administrative support is also essential to the effective provision of GCP training in each RRDN. A variety of models for administrative support are in place, though the minimum expectation is that: 

• practical arrangements for consolidation workshops for facilitator-led courses (either face to face or virtual) courses will be made locally; 

• course participants will be registered on NIHR Learn; 

• help for learners wishing to access face-to-face courses and virtual workshops will be provided locally, except for technical support for NIHR Learn which will be provided by RDNCC; 

• certificates of completion for face-to-face courses and virtual workshops will be provided locally, either through appropriate use of relevant functionality within the NIHR Learn system or by other means.

The NIHR RDN GCP programme consolidation workshops and e-learning courses are provided to participants free of charge. Costs associated with venues and catering for face-to-face GCP courses should be met locally, either by RRDNs or Partner organisations where the programme is being delivered. The GCP FDP and annual update meetings are provided to participants free of charge, though travel and accommodation costs should be met locally, either by RRDNs or the employer. 

The RDN Coordinating Centre (RDNCC) supports RRDN GCP Programme Leads, the community of facilitators and key stakeholders to maintain the quality and reputation of the programme. Specific responsibilities of the RDNCC include: 

• Development and maintenance of all GCP programme content and associated resources

• GCP Facilitator resources, provided via dedicated site 

• Provision of the classroom based elements of the GCP FDP to aid both virtual and face to face delivery 

• Provision of an annual national update meeting for GCP facilitators 

• Coordination of regular GCP Programme Leads meetings 

• Provision and maintenance of NIHR Learn

FDP: Facilitator Development Programme

GCP: Good Clinical Practice

LMS: Learning Management System

MHRA: Medicines and Healthcare products Regulatory Agency

NIHR: National Institute for Health and Care Research

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre 

RRDN: Regional Research Delivery Network

POF: Performance and Operating Framework

Version number: 3.0 

Effective from date: 1 October 2024

Stephanie Kings-Jones

GCP Subject Matter Lead and Learning Advisor

RDNCC Clinician Researcher Programme Lead

Email: stephanie.kings-jones@nihr.ac.uk  

Amanda Leslie

Learning Design Manager

Email: amanda.leslie@nihr.ac.uk