Escalation Pathway introduction
The following information is provided to support users to understand when and how to escalate issues or errors with the national Study Resource Review, or wider NCVR programme. Escalations are managed via the Clinical Research Network (CRN) in England or equivalent Devolved Administration (DA) to prevent reviewers being contacted by multiple sites
- Step 1 - Site representative notes item missing from iCT and contacts local CRN/DA
- Step 2 - Local CRN/DA uses information below to assess whether further escalation is appropriate
- Step 3a - If Local CRN/DA considers an item to be included elsewhere, they inform the site that provision is included elsewhere in the iCT for the item to be escalated. End of process.
- Step 3b - If Local CRN/DA considers item is missing, contact Lead CRN/DA
- Step 4 - Lead CRN/DA works with Study Resource Reviewer and Company Representative to have error corrected
Supporting information
What is included in the 70% indirect cost?
A standard rate of 70% is applied to NHS staff time direct costs to cover the 'real' cost of carrying out research activity. These overheads are included in the iCT at a study level.
Physical aspects: heating, lighting, building maintenance, security.
Research support functions: finance, general administration, HR, IT and corporate/strategic management of the organisation. This incorporates Cat C amendment and contract amendment activities, costs related to text messaging from primary care, Secure Data Environment Services or linked patient interface services.
If a site escalates an item which falls within the above categories, do not escalate further to the Lead CRN/DA. Explain to the site that the 70% overhead includes provision for the above.
What is included in the 20% capacity build?
A standard rate of 20% is added to both NHS staff time direct costs and investigations. Capacity build is added by the iCT at site level - so it is not visible in the study level costs. This is considered 'system optimisation' for building sustainable research infrastructure, building capacity to innovate, skill retention, and strengthening capacity and eligibility for future research projects.
Examples of uses of the 20% capacity build include:
Training courses for staff, employing additional staff members, onsite subsistence for participants as investment in research experience, funding out of hours supplements.
If a site escalates an item which falls within the above categories, do not escalate further to the Lead CRN/DA. Explain to the site that the 20% capacity build includes provision for the above.
What is included in the Market Forces/Research Factor?
A further adjustment value accommodates the unavoidable price differences of providing healthcare across the country. Each site has their own factor which is added by the iCT at site level - so it is not visible in the study level costs. From October 2023, this factor will be overseen by the Commercial Costing Reference Group and include a multiplier to enable organisations to commit to a no negotiation position.
It includes provision for indirect staffing (academic support functions, clinical requirements and oversight), regional expense, land cost and rates index, buildings and physical infrastructure required for clinical governance, outsourcing, local fast track approval services, local innovative services. It is intended to smooth out differences in localised research facilities, as well as maintaining accreditation (eg Phase 1 - part of CRF element of multiplier).
If a site escalates an item which falls within the above categories, do not escalate further to the Lead CRN/DA. Explain to the site that the MFF and multiplier includes provision for the above.
What is classed as a pass through cost?
A number of 'pass through' costs have been identified and included as wording in the fixed Financial Appendix of the mCTA. These 'pass through' costs do not form part of the study resource review, NIHR Tariff or iCT.
Site archiving
Patient and carer inconvenience payments
Travel and off-site subsistence payments
If a site escalates an item which falls within the above categories, do not escalate further to the Lead CRN/DA. Explain to the site that the financial appendix will cover the cost of the above.
Other types of escalation
I am a company representative. A participating site is requesting adjustments to the iCT directly. What should I do?
From October 2023, no NHS Trust is able to adjust the site level iCT directly. They must use the escalation pathway described above.
I am a participating site representative. I can see open comments in the iCT audit trail which means the company has adjusted the costs after the national review. What should I do?
Companies are not able to adjust the agreed costs after the national review is complete without agreement from the national reviewer. Ask the company to revert the costs to the previously agreed ones. Contact your local CRN team to inform them.
I am a Study Resource Reviewer/Company Representative and cannot come to an agreement about the resources required in the study resource review. What should I do?
Escalate non-agreement to local Industry Operations Manager at the Lead CRN or DA equivalent. Reviewers can also use the collective experience of the Teams Community of Practice to discuss specific studies.
I have a comment/suggestion regarding the tariff values or content of the iCT. Where should I send it?
Use the iCT Feedback Form to submit requests for consideration by the Commercial Costing Reference Group.
I have a comment/suggestion regarding the wider NCVR programme. Where should I send it?
If you are an NHS staff member, utilise the Teams Community of Practice or contact your local CRN industry team/DA. If you are a company we suggest you discuss with your representative on Commercial Clinical Operations Group (CCOG) or your lead CRN industry team/DA.
Contact Details
England - LCRN Industry Single Points of Contact
Scotland - feasibility@nrs.org.uk
Northern Ireland - NCVR@hscni.net
Wales - healthandcareresearch@wales.nhs.uk
Further Resources
Income Distribution from NIHR CRN Industry Studies
NCVR SOP available via Teams Community of Practice or local CRN/DA contact