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New templates published to streamline commercially sponsored trials set-up

Last updated on 5 Mar 2018

The HRA has welcomed two new agreement templates that will make it easier for life-changing medicine and vaccine research and development to take place across different parts of the UK.

The February 2018 Model Clinical Trials Agreement (mCTA) and Clinical Research Organisation Model Clinical Trials Agreement (CRO-mCTA) replace country-specific  versions and mark a significant step in streamlining commercially sponsored trial set-up across the UK health service, cutting out unnecessary administration.

At the moment companies have to spend time preparing contracts in each of the four nations for the same study, but the revised templates will allow a single contract for commercial research and development to be used in England, Scotland, Wales and Northern Ireland.

The latest templates will be able to be used across the whole of the UK and have been updated to reflect current practice and regulations.

More information can be found on the ABPI website.

The templates, guidance document and information on how to give feedback can be found in the ‘templates and supporting documents’ section of IRAS Help pages.

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