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HRA Now: updated template agreements |
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What: Updates to model Clinical Investigation Agreements (mCIAs), Primary Care model Clinical Trial Agreements (PC-mCTAs) and model Non-Interventional Study Agreements (mNISAs)
Who: Commercial sponsors, clinical research organisations (CROs), NHS Trusts and primary care organisations such as GP surgeries
When: Published for use from now
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model Clinical Investigation Agreements (mCIAs)
The new April 2023 versions of the mCIA and CRO-mCIA are now available. They are updated to bring them in line with the guidance on the set-up of interventional research, and to support the delivery of research in a hub and spoke model, where appropriate.
The commercial hub and spoke agreement is not currently suitable for use with the mCIAs. Whilst this remains the case, any sponsors planning to deliver an investigation of a medical device using a hub and spoke delivery model should either amend the hub and spoke template to reflect that the trial is a clinical investigation of a medical device, or use a bespoke agreement.
We expect that the April 2023 version of the mCIA/CRO-mCIA is submitted with any IRAS applications from sponsors for commercial clinical investigations of medical devices. The September 2021 versions will continue to be accepted in IRAS submissions until the end of October 2023 as part of a grace period. The 2014 nation specific mCIAs are no longer accepted in IRAS submissions.
Primary Care model Clinical Trial Agreements (PC-mCTAs)
The new April 2023 versions of the bi-partite and tri-partite PC-mCTAs are now available. The major change is to bring them in line with the guidance on the set-up of interventional research, and to support the delivery of research in a hub and spoke model. Further changes are described in the updated guidance document, where appropriate.
Where a commercial interventional research study is to be delivered under a hub and spoke model, the April 2023 PC-mCTAs should be used to contract between the sponsor and lead trial site, with the commercial Hub and Spoke agreement used between lead trial site and other trial sites.
We expect that the April 2023 version of the bi-partite or tri-partite PC-mCTA is submitted with any IRAS applications from commercial sponsors for clinical investigations of investigational medicinal products which are taking place in independent contractors of NHS primary care services. The January 2021 versions will continue to be accepted in IRAS applications until the end of October 2023 as part of a grace period. The January 2021 versions are not designed for use in a hub and spoke model and should not be used in this instance.
model Non-Interventional Study Agreements (mNISAs)
The new April 2023 versions of the mNISA and CRO-mNISA are now available. The major changes from the previous versions are:
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corrections of typographical errors in CRO-mNISA
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clarifications in clauses that the agreements are suitable for use with primary care organisations
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making clauses about recruitment or enrolment of participants optional so that the agreements can be used for studies where there is no recruitment of participants, for example studies only using anonymised data
The April 2023 versions of the mNISAs should be submitted in all IRAS applications by commercial sponsors for non-interventional research. The January 2022 versions will continue to be accepted in IRAS applications until October 2023 as part of a grace period.
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This is a HRA Now update, bringing you important operational updates from the HRA – including changes to guidance or processes which might affect you.
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