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Model site agreements (model contracts, standard research agreements)

Contents

Unmodified use of the appropriate UK Template Model Agreement helps to speed up the contracting process for studies carried out in the NHS, by removing site-by-site review and negotiation. Unmodified use is a general expectation and, in some cases, an obligation for the NHS - as set out in the National Directive on Commercial Contract Research Studies. This standardised approach protects all parties, enables studies to start earlier and gives NHS patients faster access to innovative treatments in high quality research.

The suite of model site agreements are supported by guidance which sets out the aims and provides details on how the agreement should be used in the development of contracts for clinical research sponsored by pharmaceutical, biopharmaceutical or medical technology companies.

Access the suite of model agreements

For more information and to access the latest versions of model agreement templates, visit the IRAS website.

model Industry Collaborative Research Agreement (mICRA)

The model Industry Collaborative Research Agreement (mICRA) launched in February 2011 aims to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK.

A Decision Tree is available to guide users in identifying when studies are collaborative and whether mICRA is applicable.

The mICRA was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, universities, the NHS, and the Intellectual Property Office, worked together with expert legal opinion to develop a model Agreement that can support all collaborative research scenarios. Organisations involved in the working group have agreed a Statement of Endorsement encouraging its use, to streamline the contracting process for collaborative research.

Feedback on the use of the mICRA is welcomed to help inform its future development. Email comments to nocri@nihr.ac.uk