Commercial Clinical Trial Agreements

The NJRO encourages the use of the Department of Health (DoH) Model Clinical Trial Agreements between the NHS and Industry for commercial studies running through the Trust. These model agreements have been devised following extensive negotiation between

  • DoH
  • Association of the British Pharmaceutical Industry (ABPI)
  • BioIndustry Association (BIA)
  • Association for British Healthcare Industries (ABHI).

The agreements create a standard contractual framework for commercial studies ran within NHS organisations and cover legal issues, financial issues, indemnity and protection of confidential information.

The NJRO is responsible for reviewing and negotiating all clinical trial agreements and it is important to forward any proposed agreements to us as soon as possible. Whilst we prefer to review the legal content of the agreement as soon as possible, the agreement cannot be finalised until the costs for the study have been reviewed and approved, and the study teams have confirmed the necessary arrangements for the study are in place.

For more information on the Trust’s set up and review process for commercially sponsored studies, please see ‘Commercial Research and Newcastle Hospitals

All Clinical Trial Agreements must be signed by the Trust Secretary following review and confirmation of capacity and capability by R&D.

The DoH Model Trial agreements can be found here.

 

Image: Patient being injected