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Further updates to model contract agreements for NHS and health and social care organisations announced

Further updates to model contract agreements for NHS and health and social care organisations announced

Commercial agreements and guidance published in December 2023 have been updated by the Four Nations Contracts Leads following feedback from commercial sponsors, Contract Research Organisations and the NHS

The Health Research Authority (HRA) have updated the following suite of agreements as part of 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:

  • Model Clinical Trial Agreements (mCTAs)
  • Model Clinical Investigation Agreements (mCIAs)
  • Model Non-Interventional Study Agreements (mNISAs)
  • Model Commercial Participant Identification Centre Agreement (mC-PICA)
  • Model Commercial Hub and Spoke Agreement

The changes to these agreements are designed to make it easier to reflect National Contract Value Review (NCVR) negotiated and non-NCVR negotiated financial arrangements.

The main changes coming into effect are:

  • Carifying which party is supplying investigational drugs, and payment arrangements when the trial site is supplying them (mCTAs only)
  • Setting minimum prices for physical and electronic archiving fees
  • Adding a way to confirm caps for different types of expenses
  • 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
  • Adding a new clause for ethically-approved participant payments
  • 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

Applicants must include the appropriate new UK template agreement in their IRAS submission. Any agreement not already exchanged as of 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.

Previous agreements for any IRAS submission on or after 19 May 2025 will not be accepted.

Research and development managers at participating sites are being asked to cascade this information across your organisation to all those who may be currently involved in costings or contracts.

All contracts are reviewed every six months and updated as needed, based on feedback. You can find out how to share new feedback on the contracts or finance appendix in IRAS Help.

Publication date: 21st May 2025

Author: NHS Research Scotland

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