Commercially Sponsored Clinical Trials

For commercially sponsored research hosted by NUH, the R&D Department request that the ABPI contract templates be utilised to ensure accuracy, efficiency and consistency in the contracting process. The model CTA is specifically for use in connection with pharmaceutically sponsored clinical trials carried out in NHS Trusts in England recruiting NHS patients.

For further information on NUH’s commercial processes please visit the Life Sciences Industry section.

The bipartite format of the Agreement should be used when the management and funding of a clinical investigation is maintained by the Sponsor.

Trial of an Investigational Medicinal Product (CTIMP)

Trial of a Medical Device

The tripartite format of the Agreement should be used when the management functions of a clinical investigation is outsourced by the Sponsor to a Contract Research Organisation (CRO). This will often be used where the Sponsor of the research is situated outside of the UK and the CRO will be the legal UK representative

Trial of an Investigational Medicinal Product (CTIMP) (CRO mCTA)

Trial of a Medical Device (CRO mCIA)

NB: Commercial research studies using the industry standard template (NHS-ABPI-BIA model Clinical Trial Agreement 2006) does not require an additional agreement for the transfer of material.

Further information and guidance on the use of the model NHS/ABPI CTA can be found in an ABPI guidance pdf.

Medical Equipment Contract Appendix

There are numerous occasions when medical equipment will be brought into NUH for the purposes of a research study. All equipment entering Trust premises are required to undergo functionality and safety testing by the Clinical Engineering Department prior to being approved for use on NUH patients.

The R & D and Clinical Engineering Departments have worked closely together to align their processes and R & D has generated an Appendix which addresses the issues surrounding medical equipment. This template Appendix should be incorporated into the Clinical Trial Agreement for any research bringing equipment into the Trust and should be brought to the attention of the Sponsor/equipment provider at the earliest opportunity to ensure minimal delay in the contractual negotiation stages.