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Commercial Research Contracting

A single contract draft policy for Scotland where wording is agreed once on behalf of all sites

Clinical Trial Agreements

Scotland operates a ‘single contract draft’ model for commercial research. As part of the study level review, the lead reviewer will negotiate and agree on contract wording with the sponsor on behalf of all sites participating in the study.

The single contract review is achieved through the use of the ABPI model clinical trial and investigation agreements, submitted unchanged where at all possible.  The ABPI agreements contain nationally accepted contract terms and forms part of the study submission checklist.

Equipment Indemnity

Equipment loaned to the NHS to facilitate a research project must be fully indemnified.  In Scotland, companies on the Master Indemnity Agreement (MIA) register can provide equipment to support trial activity without the need for additional agreements so long as the loaned equipment is not the subject of the research project.  Suppliers on the MIA register are listed here.

Where companies are not listed on the MIA register, an agreed NRS indemnity contract will be required by each Board in addition to the clinical trial agreement.

Frequently Asked Questions

Can we accept modifications to the model contracts?

  • It is preferred that the model contract is used unchanged; however, the lead reviewer will be able to assess any changes and advise on acceptability to Boards in Scotland.

How can contracting timelines be accelerated?

  • Using the model contracts unchanged makes agreeing on the contract a formality and is very quick.
  • Where there are negotiations on the wording, maintaining momentum throughout the negotiations will ensure wording can be agreed rapidly.