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HRA Now: New Model Agreement templates published to reduce the time taken to set up commercial studies in the UK

What: New Model Agreement templates:

• Model Confidentiality Agreement (mCDA)
• Model Non-Interventional Study Agreement (mNISA)
• Clinical Research Organisation mNISA (CRO-mNISA)

Who: NHS/HSC organisations, commercial sponsors and CROs. All commercial contract research (mCDA) and all non-interventional commercial contract research (mNISA)

When: Available to use now

We aim to help reduce the time, cost and resources needed to set up commercially sponsored studies by publishing two new agreements, in line with the UK Vision for Clinical Research Delivery.

Both templates and associated guidance have been produced by a UK-wide partnership including Health and Care Research Wales, NHS Research Scotland, Health and Social Care Northern Ireland, NHS R&D Forum and industry partners. Developed as part of the UK Research Recovery Resilience and Growth Programme, they are available now alongside our other model agreements in IRAS.

Although published as a consultation-in-use, we strongly encourage all commercial sponsors and NHS/HSC organisations to use these templates without modification for maximum speed and benefit in relation to the feasibility/site set-up phase of commercial contract research.

Model Confidentiality Disclosure Agreement (mCDA) 

The Model Confidentiality Disclosure Agreement (mCDA) template is designed for the early sharing of study-specific confidential information in the feasibility/site set-up phase of your commercial contract research. The template aims to make conversations and quick decisions about taking part in commercially-sponsored research as easy as possible before executing the site agreement such as the model Clinical Trial Agreement (mCTA, CRO-MCTA or model Clinical Investigations Agreement (mCIA).

This template is a resource that sponsors can choose to use with NHS/HSC sites whenever they wish to formalise the arrangements for early feasibility. Doing so will reduce negotiation time with sites, provide assurances to both parties that their rights and responsibilities are appropriate and facilitate compliance by sites with contract terms.

This model is site specific and should not be used as a master agreement.

Model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation mNISA (CRO-mNISA) 

These are the first UK templates designed for use with non-interventional commercial research with NHS research participants (including HSC research participants in Northern Ireland) throughout the UK Health Services.

Any changes to the mNISA or CRO-mNISA model agreements should be clearly identified and justification provided within the IRAS application.

Next steps

We are developing further contract templates in line with our commitment to facilitate clinical research in the UK and as part our role in the UK Recovery Resilience and Growth Programme.

Questions or feedback should be sent to the appropriate contracting lead: 

• England: please contact the Health Research Authority by email to alastair.nicholson@hra.nhs.uk
• Wales: please contact the Health and Care Research Wales Support and Delivery Centre by email to research-contracts@wales.nhs.uk
• Scotland: please contact NHS Research Scotland by email to enquiries@nrs.org.uk
• Northern Ireland: please contact HSCNI by email to researchcontracts@innovations.hscni.net

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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