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Research and Development

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Contract considerations

If any third party (including commercial involvement, facilities or services from an NHS trust or other university) is involved, then contracts and agreements need to be in place prior to trial start.

These include:

  • supply of the medical device
  • funding / educational grant
  • laboratory and / or pharmacy services
  • out-of-hours code breaking services
  • emergency medical cover
  • participation of other sites (in multicentre studies).

OUH R&D can help identify what agreements are required. The OUH Contracts Team will help put these in place.

OUH Contracts Team

Oxford University Hospitals has a team of people which negotiates research contracts with sponsors and/or contract research organisations on behalf of the Trust.

Once research teams are aware that their research proposal requires a contract, they can send through a draft contract and a copy of the protocol for review as soon as practicable.

The Trust has a policy of requiring those contracts that are a modified Department of Health standard template, or a sponsor own brand template, to be fully executed before local Trust Management Approval can be given to the on-site study team following the review of capacity and capability.

However, if a contract is an un-modified model agreement, then the submission of the draft contract can occur in parallel with the process of confirming the capacity and capability of the Trust to take part in the proposed project.

The current list of studies that require a contract and costing are:

  • clinical trial of an investigational medicinal product
  • clinical investigation or other study of a medical device
  • combined trial of an investigational medicinal product and an investigational medical device
  • other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
  • any study sponsored by a commercial company.

Undertaking a commercial research project is different to other projects in a number of key respects:

  • The way that commercial research projects are costed is different from non-commercial research. Essentially, a commercial funder has to meet all the costs of a research project, including overheads.
  • Indemnity arrangements are different, because for many commercial studies the company has to provide indemnity to cover the researcher in the event of non-negligent harm.
  • All commercial trial agreements have to be approved by the Trust, and so cannot be handled independently by the researcher.