Participants and source data
All Commercial Projects involve participation from the external Sponsor, the Research Team, R&D and R&D Finance to arrive at the finance approval of the Study costs.
Projects normally start with the Sponsor and the Research Team who will agree involvement in the Trial based on the trial requirements and the Protocol. At an early stage Staff activities and Support department procedures are identified which will become the basis of the Financial Costing.
Use of Industry costing template
It is the Trust’s policy to use the NIHR Industry Costing Template where possible. In this situation the Costing Proforma may initially be presented by the Sponsor with the Research Team providing any initial amendments deemed necessary. If the Industry Template is not used, there are internal Costing Templates available to build up the cost.
Each activity mentioned in the protocol or site specific information (SSI) are separately identified and costed on the template. This provides visibility as to how the income is derived and also provides a means for R&D Finance to verify the completeness of the costing exercise.
All staff are costed using Industry template staff rates and includes a mark up of 70% to cover overheads and 20% for R&D capacity building. As per the R&D’s strategy document, the income relating to half of the 70% overhead is allocated to the research cost centre, and the other half is allocated to the R&D department. This together with the capacity building element is required to recover the cost of its activities in addition to support for pump-priming projects.
Inclusion of University of Nottingham staff in costing template
Clinical Trial Agreements involving recruitment of NHS patients must be between NUH (since it has a duty of care towards those patients) and the sponsor or sponsor’s representative. Commonly the University of Nottingham employs the Principal Investigator or other university staff, and therefore it is necessary to include it in the costing process.
Procedures and investigations performed by the University must be separately identified and will form the basis of the subcontract agreement with the University.
Procedures and investigations performed by NUH staff and the respective 70% overheads and 20% R&D capacity building are assigned as being NUH’s.
Where University Consultants are paid wholly by NUH or their R&D PAs are paid by NUH, then these costs will be assigned as being NUH’s.
Inclusion of Treatment Centre staff in costing template
In addition, the Treatment Centre operated by Nations Healthcare utilises staff seconded from NUH in trust studies and therefore must be recompensed for their time. The rates per the industry templates are utilised to calculate the study income. However, for the purposes of calculating amounts due to Nations Healthcare, rates per the staff service agreement between NUH and Nations are utilised.
As for University staff, Procedures and investigations performed by Nations must also be separately identified to form the basis of the subcontract agreement with Nations.
Verification and approval by R&D Finance
From the information received into the R&D department, the first financial verification will be the build up or verification by RM&G Facilitators of a Costing Proforma that has either been pre-completed (e.g. Industry Template) or requiring completion by the R&D department. This is based on a verification of Protocol and SSI information that provides a clinical vetting that all non Standard of Care activities /procedures are covered correctly in the costs.
When this process has been completed, the Costing Template is passed to R&D Finance for the attention of the Commercial R&D Accountant who will review calculations and any Sponsor Draft Agreements and verify that all costs appear covered, by spot checking the make up of costs. Any queries are returned to the relevant RM&G Facilitator in the R&D department for discussion with the Research Team and/or Sponsor and any amendments made.
When the Template is agreed it is signed off by R&D Finance and returned to the relevant RM&G Facilitator for the final Agreement to be prepared for signing.