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

Background

The Commercial Contract Site Selected Letter of Intent is a non-legally binding agreement between the commercial sponsor or Contract Research Organisation (CRO) and NHS organisation. It is agreement between the two parties that the NHS organisation has been selected as a site in the named study, on the basis of the information described therein and, where relevant, attached to the email in which the Letter of Intent is sent. It is formal acknowledgement and agreement by both parties that the NHS organisation will have the capability, and that both parties will work to put in place the capacity, to deliver the study according to the timelines set out. The Letter of Intent should only be sent, and the NHS organisation formally selected as a site, following sponsor ‘due diligence’. This due diligence includes engaging appropriately with representatives of the Research and Development function and support departments of the site, in addition to the Principal Investigator (PI) and any relevant members of their research team, during site selection / qualification.

Testing of this new agreement will seek to explore and standardise the appropriate level of information and documentation required by the NHS organisation, to agree to be formally selected as a site and to work to set up the study. In its earliest form, it does not stipulate a specific document pack as a basis for the decision, although it is expected that a ‘near final’ protocol (marked as draft / not for use, or similar) will be provided, as a minimum. The Letter of Intent will test ways of ensuring that the appropriate departments and individuals are involved in the site selected decision, either directly in the site selection visit, or by processes built around this. The testing phase will also explore the efficiencies that may be achieved by ensuring that set-up activities occur in parallel to NCVR and regulatory approvals, whilst exploring the implications of set-up activity occurring with an evolving set of documents and information.

Site set-up activity occurring in parallel to NCVR and regulatory approvals is the key principle behind the Letter of Intent, and forms part of the health system’s response to the government’s 150 and 90 day study and site targets.

It is anticipated that the initial testing phase will see rapid iteration of both the template and the guidance, as we learn from their implementation.

UK Single Commercial Contract Process

Although the Letter of Intent is not a legally binding contract, it is being tested as part of the UK Clinical Research Delivery programme (UKCRD) workstream on the UK Single Commercial Contract Process. This process sets out a three-stage agreement journey for commercial contract research, as follows:

1. Early site identification, including (where relevant) expressions of interest, leading to execution of UK template Confidential Disclosure Agreements (or addition of study onto UK template master agreement) with those NHS organisations that the sponsor/CRO wishes to engage with in further detail. At this point a full draft protocol, and supporting information and documentation, is shared with Research and Development office, prospective PI and representatives of key support departments (often directly facilitated by Research and development). This documentation will be clearly marked as draft and not for use (or otherwise clearly marked and controlled, as per sponsor / CRO policies and processes, to ensure no research use, including provision to patients, is made of it). The sponsor / CRO and site jointly consider whether, on the basis of the information known and provided at this stage, the site is likely to have the capability and will be able to put in place the capacity, to set up and deliver the study according to an agreed timetable. A site selection/qualification visit is usually undertaken, often in person but sometimes remotely. It is critical that the Research and Development office, PI and each key support department are represented in this visit, either directly or by an appropriate, formally delegated individual. Where key parties are represented by delegation, unambiguous communication pathways must be established so that the right people are making the decision. Where there is agreement in the visit that the site will have the capability and can put in place the capacity within the agreed timeframe, to set-up and deliver the study, the contracting process moves to the next step. Where there are actions necessary, including answers to questions and/or additional information, before it can be agreed that the site will be selected, these actions must be completed, to the standard agreed, before moving to the next step.
   
   
2. The Site is formally Selected, by provision by the sponsor or CRO, to the now agreed site, of the UK Commercial Contract Site Selected Letter of Intent, including additional attachments as previously agreed between the parties. Provision by the sponsor / CRO denotes agreement between the parties that the site is selected and will commence set-up activities to the timescale specified. We will test the appropriate level of detail for the set-up timetable, as well as the appropriate level of detail for the set-up plan. The Letter of Intent is not a legal contract and should not be signed by the sponsor/CRO or countersigned by the site. Receipt by the site denotes formal agreement, unless the site believes that the sponsor has not undertaken the actions agreed during the site selection/qualification processes (sponsor due diligence), in which case the site must notify the sponsor / CRO and escalate for arbitration. The Letter of Intent sets out the key dates in the agreed pathway to site initiation, provides key contact and escalation details and requires both parties to actively keep the other party informed of any change of circumstances, information or timescales. Once the Letter of Intent is received, the site is no longer assessing the feasibility of delivering the study but is actively making arrangements to deliver it, in accordance with agreed timetable and plan.
   
   
3. The Site Confirms that it has the Capacity and Capability in place to deliver the study and is requesting that the sponsor / CRO initiates the site and provides formal green-light. In England, Northern Ireland and Wales, confirmation of capacity and capability is provision to sponsor (and CRO, as applicable) of the counter-signed Site Agreement (for example, mCTA, mCIA, mNISA). In Scotland, an NHS Management Permission is issued additional to the contract exchange. This stage should be in accordance with the timelines set out in the Letter of Intent (or in accordance with updated information exchanged between the parties in a timely manner). This step should trigger the final actions by the sponsor / CRO to initiate the site and provide it with regulatory green-light (other phrases may be used) to commence study specific research activities. What constitutes these initiation and green-light activities should be made evident by the sponsor / CRO to the site well in advance, ideally (in outline, at least) during the site selection process.

The Letter of Intent step of the above process is currently in early testing. We invite commercial contract sponsors or CROs, who have a research project that will be undertaking site selection or qualification visits from November 2025 through to early 2026, to volunteer to test the template.

We also welcome feedback from commercial contract 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