The costs of undertaking activities to fulfill the role of sponsor for non commercial NHS research, although not explicitly referred to in current guidance, are classified as a research cost. Historically, NUH did not include these costs in grants. However, the landscape has now changed: central R&D Support Funding has been removed; NIHR clinical research network funding supports service support costs of NIHR portfolio studies only; there is increasing financial pressure on NHS trusts and universities to ensure that all funding (clinical and research) is transparent and research costs are all identified and funded appropriately. As a result, NUH R&D has produced this guidance on how the costs for sponsorship activities are going to be met and what appropriate fees will be charged depending on the type of research study.

Student projects
No sponsorship fee

Single site (NUH only) Non CTIMP studies
£1,500 single payment for the provision of the following services:

• Contract management including financial oversight and funder reports
• Advice/Support
• Trial registration
• Externally accessible server space for hosting web applications (websites,
  document repositories)
• Patient and Public Involvement (PPI) advise and support

Multiple site Non CTIMP studies

£1,000 single payment plus £500 for every site for the provision of the following
services:

• Contract management including subcontracts, financial oversight and
  funder reports
• Advice/Support to additional sites
• Trial registration
• Externally accessible server space for hosting web applications (websites,
  document repositories)
• Patient and Public Involvement (PPI) advice and support

Single site (NUH only) CTIMP and Medical device studies

£5,000 set-up fee plus £2,000 per year for the provision of the following services:

• Trial registration
• Externally accessible server space for hosting web applications (websites,
  document repositories)
• Patient and Public Involvement (PPI) advise and support
• Monitoring including development of monitoring plans, site visits (and associated
  travel costs), attendance at data monitoring committees
• SOP compliance audits
• Contract management including financial oversight and funder reports
• Site set‐up – site files, delegation logs etc
• Pharmacovigilance including safety reporting
• Contribution to sponsor overheads including MHRA GCP inspection fees,
  environmental monitoring equipment
• Archiving by a certified archivist in a secure facility for 15 years following study
  closure
• Support/advice with regulatory approvals including completion of forms (MHRA,
  REC)
• Training of study staff (e.g. GCP, pharmacovigilance, SOPs)
• Advice/Support

Multi site CTIMP and Medical device studies

£5,000 set-up fee plus £2,000 per year per site for the provision of the following
services:

• Trial registration
• Externally accessible server space for hosting web applications (websites,
  document repositories)
• Patient and Public Involvement (PPI) advise and support
• Monitoring including development of monitoring plans, site visits (and associated
  travel costs), attendance at data monitoring committees
• SOP compliance audits
• Contract management including financial oversight and funder reports
• Site set‐up – site files, delegation logs etc
• Pharmacovigilance including safety reporting
• Contribution to sponsor overheads including MHRA GCP inspection fees,
  environmental monitoring equipment
• Archiving by a certified archivist in a secure facility for 15 years following study
  closure
• Support/advice with regulatory approvals including completion of forms (MHRA,
  REC)
• Training of study staff (e.g. GCP, pharmacovigilance, SOPs)
• Advice/Support