Update on model template agreements
The 2021 mNCA, mCTA, CRO-mCTA and Primary Care mCTAs have now been published and are available on IRAS Help.
The templates have been updated to reflect the legal situation following the end of the transition period for the UK leaving the EU, as well as a number of updates reflecting feedback received. Details of the updates made are available in the associated guidance documents.
The nation specific Primary Care mCTAs have been replaced with two UK-wide templates (following the example set with the mCTA), one to be used where the contracting parties are sponsor and independent contractor general practitioner and the other to be used where the PI GP is also party to the agreement.
2018 and earlier versions of mCTA and CRO-mCTA will no longer be accepted in IRAS submissions.
2020 versions of mCTA and CRO-mCTA, and 2013 versions of Primary Care mCTA, will be accepted in IRAS submissions until 1 July 2021, although commercial sponsors and CROs have been advised to adopt the 2021 versions as soon as possible.
For studies already approved and/or submitted, sponsors may continue to use the submitted template agreement with sites not yet contracted, although sponsors have been notified that this may lead to increased delay in site negotiation over time. Sponsors who wish to swap in the appropriate unmodified current template for sites not yet contracted may do so without submitting an amendment. Sponsors wishing to use modified contracts must submit this request to the lead nation coordinating centre for consideration of the proposed modifications. It is not recommended that contracts already executed are varied to incorporate the revised terms.
Commercial sponsors (and CROs) have been informed that any request to use a modified version of a contract (for a new submission or by amendment) is likely to result in significant delay. NHS sites in England and Wales are prohibited from negotiating modified commercial site agreements unless the HRA and HCRW Approval for the study provides a waiver for this. Similar expectations for unmodified use are in place in Scotland and Northern Ireland. Waivers for use of a modified 2020 or 2021 mCTA or CRO-mCTA will not be issued unless agreed by all four UK nation contracting leads.
Updated versions of mCIA and MICRA are currently in preparation. Additionally, the contracting leads group is working on the creation of a non-interventional commercial site agreement, an ATMP specific mCTA, a hub and spoke template for use between multiple NHS organisations comprising one Investigator Site, as well as other additions to the suite of template agreements.
Questions relating to the above, or other site agreement related matters, should be addressed to the relevant national contracting lead, as follows:
England: Alastair.Nicholson@hra.nhs.uk
Northern Ireland: david.brownlee@innovations.hscni.net
Scotland: Douglas.Young@nhslothian.scot.nhs.uk
Wales: Fiona.Dunn3@wales.nhs.uk
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