The Health Research Authority (HRA) in conjunction with the Four Nations Contracting Leads Group has recently published the new model Non-interventional Study Agreement (mNISA) & CRO model Non-interventional Study Agreement (CRO mNISA).

These new model agreements are the first UK templates designed for use in non-interventional commercial research.

The model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation model Non-Interventional Study Agreement (CRO-mNISA) are designed to be used without modification for company-sponsored commercial non-interventional research with NHS research participants (including HSC research participants in Northern Ireland) throughout the UK Health Services.

Although these templates are currently published as consultation in use, it is strongly recommended that the appropriate template is used without modification, to ensure that all parties are compliant with requirements and expectations and to avoid potentially significant delays associated with negotiating proposed modifications.

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

Developed as part of the UK Research Recovery Resilience and Growth Programme, they are available now alongside our other model agreements in IRAS.

We strongly encourage all commercial sponsors and 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.

Feedback 

Questions and/or feedback from HSC/NHS organisations on the mNISA & CRO-mNISA and its use should be provided to HSC Innovations at ResearchContracts@innovations.hscni.net, whereby these will be raised directly with the UK Contracting Leads group.

Assistance

For assistance with queries relating to the mNISA & CRO-mNISA and other template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact HSC Innovations.  All correspondence should be sent to ResearchContracts@innovations.hscni.net for further information and assistance.

To download the documents click on the relevant link below.