In North Thames we deliver the national Study Support Services which helps researchers and the life sciences industry plan, set-up and deliver high quality research to time and target in both the NHS and the wider health and social care environment, across the CRN North Thames region.
The service exists to facilitate the smooth and timely progression of studies, from initial early engagement and identification of sites, through to successful delivery.
Here, we have described how we tailor each of the Study Support services in our network.
- CRN Portfolio eligibility
- Early Contact and Engagement
- Early feedback
- Site identification
- Optimising delivery
- Effective Study set-up
- Performance monitoring
- Research activity and Business intelligence.
The NIHR Clinical Research Network (CRN) Portfolio of studies consists of clinical research studies that are eligible for support from the NIHR CRN in England.
All high-quality research studies, eligible for NIHR CRN support in England, are included on the NIHR CRN Portfolio. NIHR CRN supported studies benefit from the following:
- Access to the NIHR CRN Study Support Service - a standard national framework for supporting the planning, set-up and delivery of high quality clinical research in England.
- Provision of NHS support as defined by Attributing the costs of health and social care Research and Development (AcoRD) and/or the equivalent of NHS Support in other settings (e.g. research carried out in social care, care homes, hospices, or public health settings).
- Provision of Research Part B costs as defined by AcoRD (for studies funded by AMRC member charities only).
- Access to relevant research delivery training, including Good Clinical Practice training.
- ISRCTN registration via the Central Portfolio Management System. Registration of non-commercial studies with an interventional component is funded by the Department of Health and Social Care.
NIHR CRN support is available to all studies, regardless of location, study type, study size, therapy or research area, provided they meet the Department of Health and Social Care established eligibility criteria.
For more information on CRN Portfolio eligibility for Industry please contact: firstname.lastname@example.org
For more information on CRN Portfolio eligibility for Non-Commercial please contact: email@example.com
We can offer advice and guidance on:
- Eligibility advice
- Regulatory submissions
- Assistance with costing your study
- Exploration of recruitment pathways
- Local intelligence to optimise delivery
- North Thames' harmonised approach to study set-up.
Commercial contract support
We can provide advice to sponsors, Contract Research Organisations (CROs) and sites on commercial research budgets and contractual arrangements. We can support the following:
- Development and validation of study-specific industry costings
- The use of NIHR CRN interactive Costing Tool and access and use of the Tool through the Central Portfolio Management System
- National Directive for Commercial Contract Research Studies and the NHS England National Contract Value Review process and implementation.
To find out about any of the above, contact the industry team on: firstname.lastname@example.org
Non-commercial AcoRD support
We have AcoRD Leads within North Thames who are able to ensure researchers have all the support they need around the attribution of study activities.
We can provide the following support:
- Schedule of Events costing attribution tool validation at grant award stage and regulatory submission
- Support the identification and approval of Excess treatment costs.
To find out more information, contact the AcoRD team on: email@example.com
For more information or support required pre-grant you can access the service via the Research Design Service in London.
You can also find NIHR funding opportunities on our Funding Opportunities page.
In addition to the central service we are able to offer local advice to industry life science and non-commercial partners. This advice includes the feasibility of successful study delivery based on local services, population and care pathways.
We optimise delivery through the Study Support Service, a free of charge service designed to be tailored to the needs of your study.
Using our knowledge of local sites, services and populations, combined with relevant performance data, we can provide additional information to enhance and complement a sponsor’s own feasibility assessment. We strongly encourage CRN attendance at site qualification and feasibility meetings. This allows us to gather first hand, study and local intelligence in order to streamline the set-up process, remove duplication and identify challenges early to proactively address them. It also provides an opportunity to discuss recruitment and contingency plans and explore alternative and novel recruitment strategies.
Invitations for site qualification/site selection and feasibility meetings can be made directly to the CRN divisional teams or via the industry team. We would encourage sponsors, CRO and sites to engage early with CRN NT teams so that we can provide support throughout the site selection and set-up process.
If you would like to access this service please contact: firstname.lastname@example.org
For non-commercial studies we offer this service through a CRN National Study Delivery Assessment. These assessments are carried out by Research Delivery Managers, with input from Specialty Leads, to support effective study start-up and appropriate performance monitoring throughout the study.
If you would like to access this service please contact: email@example.com
Building on all previous interactions with the Study Support Service, we create and implement a study-wide action plan, detailing a single set of recommendations and key information for all study sites involved in your research - enabling a ‘do once and share’ approach.
In North Thames we also operate and manage a central, harmonised process for the review and set up of studies across our network. This includes:
- Pharmacy: A single pharmacy technical review which is applicable to all study sites in North Thames
- Medical Exposure: A single harmonised technical review of study and local imaging requirements which is applicable to all study sites in our network
- Contract review: A centralised process for the review and approval of study budgets and contractual arrangements is carried out by our costing and contract team. (This process does not operate for NHS trusts in Essex or Hertfordshire)
- Study site set-up: Our divisional teams coordinate and provide support to research sites setting up a study by assessing the local requirements and ensuring capacity and capability within the local infrastructure to provide the support required to deliver high quality research data and maximise the research opportunities for our patients.
Performance monitoring is a key part of the NIHR Clinical Research Network Study Support Service - helping researchers deliver studies on time and to target.
Monthly reports are produced and shared across our network with divisional teams, Clinical Speciality Leads and NHS trust Research and Development offices to closely monitor study performance against plan and proactively address potential challenges.
We engage with colleagues at a local and national level to address difficulties, learn from good practice and explore alternative and novel strategies to participant identification and recruitment.
We provide training as well as technical support and advice for data collection and the use of information systems within North Thames. We can also help direct you to research activity reports for studies delivered in North Thames.
The data systems and platforms
New users of CPMS or ODP can create an account.
For more details about access to CPMS, please refer to the guide on NIHR Learn.
What is research activity data?
The way we collect recruitment activity data has changed
To find out more about the NIHR Research Activity Digital Innovation, visit the project page.
For more information, please contact us at: firstname.lastname@example.org