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Contracts, budget review and sign-off

All study agreements and study budgets must be reviewed by the Research & Innovation (R&I) Department prior to signatures being obtained on the contract. Agreements and budgets are reviewed by our Commercial Research Manager and once agreed, we provide the Trust signatory from R&I. Sponsors/CROs are required to send draft contracts and a validated National Institute for Health Research (NIHR) costing template to R&I as part of the local information pack, but we will accept these prior to a full pack to help to avoid delays in the set-up of new commercial studies. Agreements and budgets should be sent to the Commercial Research team in R&I.  See our contact us page for full details. 

UHBW R&I confirms capacity and capability to undertake commercial studies by providing a fully executed contract to the Sponsor/CRO and local research team. We are therefore unable to sign contracts, even if a budget is agreed, before a capacity and capability has been fully assessed, based on a valid local information pack. Read more information on the HRA website about the required capacity and capability review.  

We use the suite of model agreements that have been developed nationally in the UK with the ABPI and ABHI. The use of these model agreements in unmodified form (with the exception of the addition of the site and study specific information) can lead to a quicker negotiation process as we do not request further review from our Legal Department. If you choose to use a non-model agreement this may result in longer set-up times and legal review charges, which must met by the Sponsor.

The latest model  Clinical Trial and Clinical Investigation agreements can be found on the NIHR website.

Budget Review

We use the NIHR Industry Costing Templates to cost all industry sponsored research. The template should be completed by the Sponsor/CRO and, following validation by the HRA or NIHR CRN, sent to sites for review to initiate the negotiation process, in line with the HRA approval process for research in England.

There are templates for both pharmaceutical and medical device trials, but these are also used to cost non-interventional trials by just completing the relevant tabs.

The latest NIHR Industry Costing Templates can be found on the NIHR website.