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.
