What: Commercial agreements for participating NHS and HSC organisations have been updated
Who: NHS and HSC organisations, commercial sponsors and contract research organisations (CROs)
Where: UK wide (England, Northern Ireland, Scotland and Wales)
The commercial agreements and guidance published in December 2023 have been updated by the Four Nations Contracts Leads following feedback from commercial sponsors, CROs and NHS Trusts.
The following suite of agreements have been updated:
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model Clinical Trial Agreements (mCTAs)
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model Clinical Investigation Agreements (mCIAs)
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model Non-Interventional Study Agreements (mNISAs)
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model Commercial Participant Identification Centre Agreement (mC-PICA)
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model Commercial Hub and Spoke Agreement
What is changing?
We have made some changes to these agreements to make it easier to reflect National Contract Value Review (NCVR) negotiated and non-NCVR negotiated financial arrangements.
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clarifying which party is supplying investigational drugs, and payment arrangements when the trial site is supplying them (mCTAs only)
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setting minimum prices for physical and electronic archiving fees
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adding a way to confirm caps for different types of expenses
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adding a new clause for out of hours work which isn’t specified as out of hours in the protocol and isn’t included in NCVR, but is agreed by the sponsor and trial site as helpful to delivery of the study
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adding a new clause for ethically-approved participant payments
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adding an option to state when all screen failures will be paid for by the sponsor, with clearer instructions about how to use this clause when the sponsor will not pay for all screen failures
Do not use any previous agreements for any IRAS submission on or after 19 May 2025 as they will not be accepted.
What does this mean for sites currently in set up from 19 May 2025?
Any agreement not already exchanged as of Monday 19 May 2025 (signed by both parties and notified or returned to the sponsor) will need to use the new version of the commercial model agreements.
This means that any studies in set up with unsigned contracts will need to use the revised contract template.
You do not need to submit an amendment to use the revised contract template.
What do you need to do?
Research and development managers at participating sites please ensure that you cascade this information across your organisation to all those who may be currently involved in costings or contracts.
Your feedback is important
We have had lots of feedback about these agreements over the last couple of years. We haven’t been able to address everything we’ve heard about for this update, because we wanted to make key changes focussed on making the costing elements of the agreement more effective.
If you have already sent us feedback but your proposed changes haven’t been made this time, we still have your feedback and will review it in due course.
You can find out how to share new feedback on the contracts or finance appendix in IRAS Help.
All contracts are reviewed every six months and updated as needed, based on feedback. Please do continue to tell us what you think.
Making a more efficient and streamlined single UK standardised commercial contracting process
The changes made to these agreements are part of our work on the UK Clinical Research Delivery (UKCRD) programme which is committed to developing and mandating an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation.
You can read more about our work as part of the programme on the HRA website.
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