Updated UK model non-commercial agreement (mNCA)
We have updated the mNCA and its associated guidance (dated July 2022 version). The main changes are to:
- align mNCA with the setting up interventional research guidance
- add options to enable participating organisation to act as a Lead Trial Site which sub-contracts with other NHS organisations (Other Trial Sites) through a hub and spoke agreement
- make the data sharing terms a standard part of the contract to cover sharing pseudonymised data and/or personal data, instead of optional
- align mNCA further with the model clinical trial agreement (mCTA)
A full description of the changes is available in the mNCA guidance.
Any new submissions for HRA and HCRW Approval should use the July 2022 version of the agreement. Applications for HRA and HCRW Approval can continue to be made using the January 2021 version of mNCA until 22 May 2023. After this date, the July 2022 version will be the only accepted version of the agreement.
For submitted and open studies, sponsors may continue to propose to organisations (that are not yet set-up) the version of mNCA originally submitted in IRAS. Alternatively, they may propose the current template. If the current template is used without modification, this is not an amendment and does not need to be notified to HRA or HCRW.
We are developing a non-commercial hub and spoke agreement to support use of mNCA as a hub agreement.
New commercial hub and spoke agreement (July 2022 version)
Following on from the publication of the May 2022 model clinical trial agreement (mCTA), and contract research organisation model clinical trial agreement (CRO-mCTA) a new commercial hub and spoke agreement is published to support hub and spoke delivery models for commercial clinical trials.
The mCTAs act as the hub agreement between the sponsor (and CRO) and Lead Trial Site (participating NHS organisation). In hub and spoke models, the Lead Trial Site sub-contracts with Other NHS/HSC Trial Sites using the new template. Further information about the use of hub and spoke study delivery models is available in our setting up interventional research guidance.
It is expected that both the mCTA and hub and spoke agreement will be used unmodified. Applicants should submit both the relevant mCTA and the commercial hub and spoke agreement with their application or amendment for HRA and HCRW Approval. It should be clear in the application or amendment that a hub and spoke arrangement is being used for your study.
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