HRA Now - Help us test a new draft Commercial Site Selected Letter of Intent

Health Research Authority sent this bulletin at 21-11-2025 03:31 PM GMT

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What: Help us test a new draft Commercial Site Selected Letter of Intent

Who: NHS and HSC organisations, commercial sponsors and contract research organisations (CROs)

Where: UK wide (England, Northern Ireland, Scotland and Wales)

From today, 21 November 2025, commercial sponsors and contract research organisations (CROs) are invited to volunteer to test a new draft Commercial Site Selected Letter of Intent.

The Commercial Site Selected Letter of Intent formalises the site-selection stage of commercial contract research set-up in the UK, which is the critical decision point for commercial sponsors and CROs.

The letter is intended to help to standardise the information provided by sponsors and CROs to their prospective sites, to support better-informed joint decisions on the capability and likely capacity of those prospective sites to deliver the study.

We hope the letter will ensure the right people are involved in that joint decision and that the sponsor, CRO and site commit to work together, from the date that a site is selected, to set the study up.

Setting up a study at sites in parallel to NCVR and regulatory approvals, is a key step towards speeding up research in the UK and meeting the government’s 150 day study set-up and 90 day site set-up targets.

This first draft of the Letter of Intent has been developed following significant engagement with commercial sponsors, CROs and NHS organisations.

It is not a legal contract, but is part of the UK Clinical Research Delivery programme (UKCRD) workstream on the UK Single Commercial Contract Process.

We will iterate the template and supporting guidance regularly based on feedback we receive as part of this testing process.

Our intention is for this template to become part of the standard national UK processes, mandated in England through the national directive.

Get involved

We’re inviting anyone who represents a commercial sponsor or CRO, who has a research project that will be undertaking site selection or qualification visits from now through to early 2026, to volunteer to test the letter.

We also welcome feedback from commercial sponsors, CROs or NHS organisations that deliver commercial contract research.

If you would like to test the new template or share feedback please email Alastair Nicholson.

Read the letter

Making a more efficient and streamlined single UK standardised commercial contracting process

The testing of the draft Commercial Site Selected Letter of Intent is part of our work on the UK Clinical Research Delivery (UKCRD) programme, which is committed to developing and mandating an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation.

You can read more about our work as part of the programme on the HRA website.