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Costing Commercial Studies

A ‘single cost for Scotland’ policy enables budgets to be agreed on behalf of all sites

NRS operate a ‘single price’ model for commercial research.  As part of the study level review, the lead reviewer negotiates the study budget with the sponsor on behalf of all sites participating in the study - there is no additional requirement for validation of the costing template for studies submitted to Scotland.

The ‘single price for Scotland’ scheme is based on the most current version of the NIHR costing template. Procedure time and investigation costs are accepted as standard.  The NIHR costing template provides a transparent, comprehensive and consistent framework enabling timely negotiations and a standardised format for agreeing study budgets. 

Given that the full cost of conducting commercial research in the NHS in Scotland must be covered by the Sponsor, it is vital that the draft costing template is completed to accurately reflect the study activities mandated by the protocol and any supporting manuals (e.g. imaging, lab, pharmacy and monitoring).

Find out more about NIHR costing templates and guidance.

Frequently Asked Questions

Once agreed, can study budgets be changed at sites?

  • While 80% of ‘local’ sites accept the negotiated per patient budget terms, there are some instances where local practice means that they may need to be revised,  for example, if one site is using MRI scanning and another used CT scanning the difference in cost is usually applied
  • Due to geographical areas covered by some Boards, there can be changes to patient travel and sustenance expenses
  • Where there are significant changes to study procedure that become apparent after the release of study manuals, NRS will reserve the right to re-assess study budgets to reflect additional requirements
  • All changes to the contract are negotiated by the local team following discussion with the lead reviewer.

How can companies accelerate the budget negotiations?

  • Negotiations can be minimised by ensuring that the draft budget is completed to accurately reflect the requirements of the protocol and any associated study manuals
  • Maintaining momentum in contract negotiations, by answering queries raised by the generic reviewer in a timely manner.

Are all aspects of the study budget included in the single price?

  • Yes, start-up fees, pharmacy fees and close down fees are all included in the study budget negotiations.

What are the NRS timelines for negotiating budgets?

  • Lead reviewers can work as fast as sponsors can to complete a budget review; therefore, maintaining momentum in the negotiation stage will ensure negotiations can be concluded quickly.