UK Four Nations Contracting Leads Round Table Discussion
This event focuses on the UK Four Nations Contracting Leads discussing updated model contracts, future plans, and existing agreements in the contracting landscape. It covers key areas such as maintaining template agreements, identifying improvements, and developing new templates in line with UK-wide standards.
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Presentation Transcript
UK Four Nations Contracting Leads Updated Model Contracts Q&A and Round Table Discussion RDForum 12thMarch 2021
What we want to cover Who we are What we do What our current plans are Discussion
The UK Contracting Leads Four Nations Policy Leads Four Nations Operational Leads Four Nations Contracting Leads
The UK Contracting Leads Health and Social Care Northern Ireland David Brownlee, Innovation Advisor Health and Care Research Wales Fiona Dunn, Research Contracts Manager NHS Research Scotland Doug Young, Principal R&D Manager Health Research Authority Alastair Nicholson, Head of Coordination and Standardisation
Co-opted representation RDForum ABPI etc ..
Terms of reference Maintain and update the suite of national template agreements Identify gaps in the suite and consult, draft, etc. as necessary to fill gaps Identify, prioritise and deliver UK wide improvements Point of escalation for study specific modification requests
Current suite of agreements mCTA / CRO-mCTA (January 2021) mNCA (January 2021) Primary Care mCTA Two per UK nation (tripartite and bipartite) OID PIC Agreements mCIA MICRA
Current suite of agreements mCTA / CRO-mCTA (January 2021) mNCA (January 2021) Primary Care mCTA Two per UK nation (tripartite and bipartite) OID PIC Agreements mCIA MICRA
New templates in development CDA Stand-alone DPA Non-interventional commercial agreement ATMP mCTA Third-party provider agreement Material Transfer Agreement Central Technical Review Agreement
Expectations and Updates ALL SPONSORS: should submit the appropriate current and unmodified template agreement with their IRAS submission COMMERCIAL SPONSORS: From 1stJanuary 2021, pre 2020 mCTA and CRO mCTA no longer accepted in IRAS submissions
Expectations and Updates 6 month wash-out period, during which 2020 versions will be accepted in IRAS Sponsors setting up new sites for approved studies may swap in current UNMODIFIED mCTA, CRO-mCTA or mNCA without amendment
Expectations and Updates Under HRA and HCRW Approval (England and Wales) NHS sites cannot negotiate any modifications to COMMERCIAL templates (or non-standard template use), unless this is first waived by HRA and HCRW Approval Similar processes in NI and Scotland Waivers for modifications proposed to any nation will not be issued unless agreed by the full Four Nations Contracting Group
UK Approval UK alignment, in place of HRA and HCRW Approval and equivalent processes in NI and Scotland Ambition to embed costing and contracting within UK Approval, within IRAS NHS England led NCVR work to serve as pilot for commercial contract value review
Contacts david.brownlee@innovations.hscni.net fiona.dunn3@wales.nhs.uk alastair.nicholson@hra.nhs.uk douglas.young@nhslothian.scot.nhs.uk
