UKCRD Priority to streamline and reform the set-up and delivery of clinical trials Frequently Asked Questions (FAQs)

Table of Contents

Introduction

The UK government has a policy to streamline and reform the set-up and delivery of clinical trials to ensure the UK provides a competitive environment for the Life Science Sector.  In April 2025, the Prime Minister made a commitment for clinical trials to be fast-tracked to accelerate the development of the medicines and therapies of the future, with the current time it takes to get a clinical trial set up cut to fewer than 150 days by March 2026.

In October 2025, NHS England published the Medium-Term Planning Framework – delivering change together 2026/27 to 2028/29. This states that all NHS providers must meet the site-specific timeframes of the government’s 150-day clinical trial set-up target. To support embedding research as part of everyday care, research activity and income should be reported to boards on a 6-monthly basis. This should include details of study set-up performance, how they are meeting the terms of research contracts outside the NHS HM Treasury allocations, commercial research income and how capacity building elements of commercial contract income are used, as set out in the research finance guidance.

The policy is overseen from a UK perspective by the UK Clinical Research Delivery (UKCRD) Programme.  At the end of September 2025, the Department of Health and Social Care (DHSC) led a webinar together with delivery partners from across the system on Study Set-Up Plan update: Progress and next steps.  This was accompanied by further guidance published on 2 October 2025, which set out details for how clinical trial set-up times are to be measured and data entry requirements.

DHSC, along with partners (NHS England, Health Research Authority [HRA], National Institute for Health and Care Research [NIHR], Medicines and Healthcare Regulatory Agency and the Devolved Government Health Departments) have provided answers to the most Frequently Asked Questions (FAQs) and are proactively working with the community to clarify outstanding issues on implementing the policy to site level.  Answers to these and other FAQs will be updated in due course.

If you have any additional questions or want to learn more, please contact the UKCRD Programme at UKCRDprogramme@dhsc.gov.uk.

For data related queries, please contact your local RRDN using the details here.

Section 1 – The government’s 150-day study-level set-up target

Below are answers to the most frequently asked questions around the government’s 150-day study-level set-up target.

This is not a new target, the 150-day measure was already in existence and performance against this has been routinely published through the UKCRD Programme Performance Indicator (UKCRD KPI) Report.

The Government has set a target to cut the set-up of clinical trials to fewer than 150 days by March 2026 to ensure the UK provides a competitive environment for clinical research, giving commercial sponsors and sites confidence in consistent study set-up timelines. Achieving, sustaining and exceeding this target is key to supporting the UK’s position as a leader in life sciences, and crucially to improve health outcomes and accelerate the development of medicines and therapies of the future.

Research is exceptionally valuable to patients and the NHS. In particular, commercial research allows patient access to cutting-edge treatments before they become more widely available, with the Association of the British Pharmaceutical Industry (ABPI) estimating that on average in 2022/23, NHS Trusts were paid £26,311 per patient enrolled in commercial interventional clinical trials. However, the UK can drive significant globally mobile investment by substantially speeding up trial set-up and delivery, to the benefit of patients and the economy.

For the reporting of study-level performance against the 150-day target by March 2026, studies in scope comprise commercial interventional clinical trials that:

  • are on the NIHR RDN portfolio.
  • submitted an Initial Clinical Trial Authorisation to IRAS from 07 April 2025 or later and have subsequently received a combined review approval.
  • are expected to recruit their first participant before or on 31 March 2026 if the study is to meet its 150-day target.

The 150-day metric measures the time taken in calendar days for a single study from application for regulatory approval through to recruitment of first study participant at any site participating in the study.

Study types excluded from reporting against the 150-day target by March 2026 are listed below:

  • Observational, commercial collaborative and non-commercial studies.
  • Studies where the 150-day target is not expected to be met in the study milestone plan, such as rare disease and other low recruitment studies – using criteria that apply already in the UKCRD KPI Report – and extension studies. Definitions for these exclusions are listed here:
    • ‘Rare disease’ definition: A rare disease is a life-threatening or chronically debilitating disease that affects 5 people or fewer in 10,000 of the UK population.
    • ‘Low recruitment’ definition: Low recruitment refers to studies that – based on the UK sample size and proposed recruitment period – are expected to recruit fewer than 1 participant per month. 
    • ‘Extension study’ definition:  Extension studies, or ‘roll-over studies,’ are studies that allow for patients participating in a parent clinical trial to ‘roll-over’ into a subsequent related study to continue to observe and measure long-term safety, tolerability, and/or effectiveness.
  • Studies for which sponsors decide to opt out of the 150-day target to recognise that not all Sponsors will wish to accelerate their studies to this target. Mechanisms in which to capture this are in development, and we are working closely with Sponsors to identify and exclude these studies. Further guidance will be provided around this.

 

Please refer to section 2 of the FAQs to understand what the government’s set-up target means for participating sites.

DHSC policy for streamlining and reforming the set-up and delivery of all clinical trials is key to driving global investment into life sciences in the UK, to improve patient outcomes and accelerate the development of medicines and therapies of the future. 

Research in the NHS is vital for generating the next generation of treatments and improving health outcomes, and clinical trials can provide a significant benefit to participating patients by giving early access to new treatments and technologies. Embedding research as part of everyday care within the NHS is fundamental to this shared ambition, for the benefit of patients, the NHS and the wider economy.

Accelerating clinical trial set-up and delivery is outlined in the Life Sciences Sector Plan and the 10 Year Health Plan for England, supporting the Government’s plan for Life Sciences to support the nation’s economy as part of the Industrial Strategy, and the nation’s health in alignment with the commitments set out in the 10 Year Health Plan for England.

DHSC has published a policy statement outlining how progress will be measured towards the government’s 150-day target for clinical trial set-up. Please refer to the policy statement for further information. This statement contains the data points and NIHR Central Portfolio Management System (CPMS) data fields and definitions. Further work has been undertaken by the NIHR RDN to map these CPMS data fields to Local Portfolio Management Systems (LPMS) and have subsequently provided this additional guidance.

As outlined in the policy statement, the study level 150-day metric measures the time taken in calendar days for a single study from application for regulatory approval through to recruitment of first study participant. This aligns with existing combined review and UKCRD KPI Report timelines which uses calendar days.

We will continue to closely monitor the progress of system performance against study set-up times and work is underway to enhance and improve this to support our commitment to transparency. We are measuring the time taken in calendar days for each study from application for regulatory approval through to recruitment of first study participant. We will be monitoring the performance of individual studies, and the proportion of eligible studies meeting the 150-day target.

DHSC through UKCRD Programme has led a four-nation Study Set-Up Plan to achieve system level improvements to clinical research delivery.  The Plan was completed in two phases, with phase 1 deliverables published in April 2025 and phase 2 deliverables published in June 2025.  It remains vital that policies and guidance set out in the Plan are embedded and implemented effectively.

The newly launched NIHR Industry Hub provides a coordinated national system for setting up and running commercial studies. It focuses on identifying barriers and accelerating clinical trial set-up by targeting resource, aligning processes, working in parallel and unblocking specific issues. The Hub will provide close support to Sponsors and sites for studies in scope of the 150-day target. For commercial Sponsors this support can be received through your NIHR Key Account Managers. For sites and all other Sponsors please contact your local RRDN using the details here.

Yes, at a study-level, the 150-day metric measures the time taken in calendar days for a single study from application for regulatory approval through to recruitment of first study participant at any site participating in the study.

All devolved governments are involved in the UKCRD programme and are committed to the same targets. Devolved governments are engaged in operational and strategic discussions on process/definitions to ensure there is alignment in how data is collected and reported. Each devolved government is communicating that position separately through nation-specific guidance/policy statements.

NHS sites outside England should contact their respective support organisations for more information:

Patient and Public Involvement should start early in the design and planning of research and has no impact on the metric.  The 150-day metric measures from regulatory submission, so any involvement in documents should have completed prior to that.

The definitions for a number of time points are new. For interventional clinical trials, the new definition for first participant is now the date (in accordance with the study protocol and regulations) of the first study visit of the first participant. This is sometimes referred to as “First Patient First Visit” or “First Subject First Visit”. This change is in response to feedback.

Please refer to the policy statement for further details on definitions.

Section 2 – What the government’s set-up targets mean for sites

We strongly advise sites to begin set up processes as soon as possible in parallel to regulatory assessments. This is crucial to ensure that the government’s set-up targets are met and to maintain our international competitiveness. Further clarification is provided below.

We recognise that further clarification is required around accounting for delays outside of the site’s control e.g. delays in trial drug supply. We are committed to working collaboratively with the community to clarify and agree on these timepoints to ensure the site-level metric gives a representative and accurate reflection of site performance.

Below are the most frequently asked questions around what the government’s set-up targets mean for sites.

Yes, as outlined in the policy statement, for sites, there is an accompanying policy expectation that all participating sites for a study must complete their set-up activities within 90 days of regulatory approval.

That is, first participant first visit for sites in England must be within 90 days of the date that a study received regulatory approval, or the site being selected to take part, whichever comes later.

First patient first visit date is defined as the first date (in accordance with applicable study protocol and regulations) on which a potential participant signs an informed consent to participate in the trial.
For interventional clinical trials this is the date (in accordance with the study protocol and regulations) of the first study visit of the first participant.

The NIHR RDN Funding model will be aligned to this wider policy through its performance-based funding allocations.

The expectation is that all participating sites for a study must complete their set-up activities to recruiting the first participant within 90 days and we strongly encourage sites to begin set up processes as soon as possible in parallel to regulatory assessments to capitalise on timings.

Exclusions clarified at study level (set out in question 2 above) will be applied at site level, so sites will not be negatively affected by studies covered in these exclusions e.g. rare disease studies.

Existing data fields should be completed in LPMS. We appreciate that sites will be requiring resource to provide this data, we have therefore kept the core data to a minimum of 6 essential fields:

Data item
(these refer to CPMS Fields which cannot be modified)		Data definition
Date site invitedThe date on the sponsor email received by the site providing the near final or final protocol.
Date site selectedThe date that the sponsor emails the site following an expression of interest and sponsor due diligence process, when the sponsor requests the site to start set-up.
Non-confirmation statusThe reason why the site was not confirmed i.e. the site did not proceed, where applicable.

This is a drop-down field with the following options:
1. Sponsor declined site confirmation
2. Site confirmed no capacity and capability (declined to participate)
3. Null response
Date site confirmedThe date of the last contract signature of all the organisations involved (i.e. sponsor, site, CRO).
Date site ready to startThe date the sponsor confirms that they have given the green light and a site may begin to recruit.
First patient first visit dateThe first date (in accordance with applicable study protocol and regulations) on which a potential participant signs an informed consent to participate in the trial.

For interventional clinical trials this is the date (in accordance with the study protocol and regulations) of the first study visit of the first participant.

Further work has been undertaken by the NIHR RDN to map these CPMS data fields to LPMS and have subsequently provided this additional guidance.

Colleagues across the NIHR RRDN are able to support you with this. If you have a question, please send it to RRDN@nihr.ac.uk and put ‘150 days’ in the subject line. If you have specific support requests or queries, contact NIHR for support via your NIHR Regional Research Delivery Network (RRDN).

Sites not meeting the target may have this reflected in their NIHR RDN performance-based funding allocation, which is 20% of the overall allocation. Sites will still receive RDN funding based on historical allocation (to ensure stability) and activity-based funding associated with recruitment, study complexity and number of open and recruiting studies. Furthermore, with our messaging to ensure effective cost recovery and strategic funding opportunities, sites should not be discouraged from participating in studies and we will work closely with sponsors to exclude those studies where they have indicated they do not wish to go at the pace of this target.

This is not a new target, the 150-day measure was already in existence and performance against this has been routinely published through the UKCRD KPI Report.

The target seeks to support the UK governments policy to streamline and reform the set-up and delivery of all clinical trials (with a particular focus on commercial interventional studies) and acts as a measure to determine the success of this policy and the interventions and incentives underpinning it led by DHSC and delivered through the UKCRD Programme.

To ensure fairness and equity for research delivery organisations in measuring this target we maintain our policy on excluding from the reporting studies where the 150-day target is not expected to be met in the study milestone plan, such as rare disease and other low recruitment studies – using criteria that apply already in our UKCRD KPI Report – and extension studies. Details of exclusion criteria can be found in this additional guidance provided by the NIHR RDN.

DHSC together with system partners are closely monitoring studies and feedback across the research community in order to identify where further support and additional clarity is needed. We welcome your feedback to UKCRDprogramme@dhsc.gov.uk.

It remains vital that policies and guidance set out in the UKCRD Study Set-Up Plan are embedded and implemented effectively. The Plan was completed in two phases, with phase 1 deliverables published in April 2025 and phase 2 deliverables published in June 2025. 

On 24 October 2025, NHS England published the Medium Term Planning Framework which includes requirements for NHS providers to meet the site-specific timeframes as part of the government’s set-up target and also requires provider Boards to review research activity and income on a 6 monthly basis. As outlined in the policy statement, we strongly advise sites to begin set up processes as soon as possible in parallel to regulatory assessments to help them meet the overall target of setting up within 150 days, including regulatory approval.

The RDN offers support in the following areas:

  • Regional Data and Analytics teams – providing high-quality analytical expertise, clarifying data definitions, and ensuring robust data integrity to inform study planning and delivery.
  • Study Support Service – delivering coordinated lead network support for studies in which sites are acting as the lead organisation, ensuring readiness and smooth study initiation.
  • Agile Research Delivery Teams – deploying rapid, on-the-ground operational support to enable sites to recruit their first participant within required timeframes.

The new NIHR Industry Hub provides a coordinated national system for setting up and running commercial studies, to deliver faster and more predictable clinical research. For Sponsors and sites supporting commercial studies there is additional support through the NIHR Industry Hub accessible through your Key Account Manager. For sites and all other Sponsors please contact your local RRDN.

On 24 October 2025, NHS England published the Medium Term Planning Framework which includes requirements for NHS providers to meet the site-specific timeframes as part of the government’s set-up target and also requires provider Boards to review research activity and income on a 6 monthly basis.

NIHR RDN has created a dashboard to support sites in actively monitoring their set-up performance, and addressing any data integrity issues. Please refer to this additional guidance from the NIHR RDN on how to access the dashboard.

As outlined in the policy statement, we strongly advise sites to begin set up processes as soon as possible and in parallel to regulatory assessments to help them meet the overall target of recruiting within 150 days, including regulatory approval. We also strongly advise sites to adopt the guidance and new ways of working developed through the Study Set-Up Plan which seeks to reduce duplication and unnecessary bureaucracy.

The UKCRD Programme will continue to develop guidance and resources for the research community to support this priority. Further information can be found here.

As outlined in the policy statement, the start point for the site-level component is defined as: Regulatory approval (either Health Research Authority and Health and Care Research Wales [HRA and HCRW] approval, or suitable equivalent used by the other devolved governments) or date site selected, whichever comes later.

For sites that are enrolled later in a study, as outlined in the policy statement we have expanded the definition of start point to include date site selected and provided a definition for this.  To clarify, the policy expectation is that all participating sites for a study must complete their set-up activities within 90 days, as part of the overall target of 150 days including regulatory approval.  This metric comprises two distinct stages of site set-up:

  1. Time from regulatory approval (either Health Research Authority and Health and Care Research Wales [HRA and HCRW] approval, or suitable equivalent used by the other devolved governments) or date site selected, whichever comes later, to site opening – the metric is 60 days.
  2. Time from site opening to first participant recruited – the metric is 30 days.

Importantly, we have accommodated for the different start points for sites that are approached before or during regulatory review (start point is date of study receiving regulatory approval), and sites that are approached after approval (start point is date site selected). 

It is important to note that sites approached before or during the regulatory review process are expected to start undertaking site set-up activities in parallel to regulatory review.

The decision to participate in a study is with the site. We encourage sites to have early conversations with the study sponsor to mutually agree timelines and manage expectations. Communication and good collaboration are key to successful and timely study set-up. We strongly advise sites to engage early on these milestones with the Sponsor or CRO as early as possible.

The HRA, with devolved government partners, have published a new standard email to be used by the sponsor to confirm selection. This will provide guidance on the joint activities to precede that email. It is important for sites to recognise that if they are not in a position to start site set-up when the sponsor requests, then the sponsor may choose not to proceed with that site at all.

No, as outlined in the policy statement, sites will only be monitored against the latter 90 days metric in which to complete their set-up activities. That is, sites in England must recruit their first participant for a study within 90 days of a study receiving regulatory approval, or the site being selected to take part, whichever comes later. 

Yes, it is still desirable that a site will achieve a global first outside of the policy and government’s set-up targets. 

The new NIHR RDN funding model (from 26/27) will recognise Global and European firsts via direct payments of performance-based funding. These will sit outside of the cap and collar system for NHS Trusts, meaning that high-performing organisations can attract additional funding against the following set-up milestones:

  • First UK site to open to recruitment within 60 days of HRA approval
  • First UK participant recruited within 90 days of HRA approval
  • First European site to recruit
  • First global site to recruit

More information can be found here: NIHR RDN funding model | NIHR RDN

The NIHR RDN takes justifiable factors into consideration (e.g. rare disease, extension and low recruiting studies) when applying its Terms and Conditions for NIHR RDN support (including funding). The RDN has worked closely with DHSC to ensure that the metrics associated with the performance element of the funding model are aligned to UKCRD key performance indicators, therefore the same exceptions apply.

The RDN has recently released indicative allocations for FY 26/27 which can be found here  NIHR RDN funding model | NIHR RDN. These are indicative allocations; final allocations will be released in early 2026 based on data over the 12-month period ending 31 December 2025. This will allow organisations to improve data quality and performance and submit the most accurate/ up to date data possible to inform their allocations for next year. The RDN and DHSC acknowledges the inherent challenges in introducing performance-linked metrics for funding and are committed to ongoing monitoring and refinement of the metrics.

20% of the NIHR RDN funding model is performance-based funding and will be distributed through two mechanisms: direct payments and performance adjustments. The metrics will consider both the site performance of the 90-day element of the overall 150-day target (via direct payments) and the distinct 60- and 30- day elements via performance adjustments.

Direct payments:

Organisations will receive direct payments for achieving the following set-up milestones:

  • First UK site to open to recruitment within 60 days of HRA approval
  • First UK participant recruited within 90 days of HRA approval
  • First European site to recruit
  • First global site to recruit

Performance adjustments:

Baseline allocations are adjusted up or down depending on an organisation’s performance against these metrics:

  • Site opened within 60 days of HRA approval or site selection.
  • First Participant, First Visit within 30 days of site readiness.
  • Recruitment to Time and Target (commercial studies).
  • Increase in recruitment to interventional commercial trials.
  • Increase in the number of interventional commercial trials recruiting.

More detail can be found here: NIHR RDN funding model | NIHR RDN.

Frequently asked questions the NIHR RDN Funding model can be found here: NIHR RDN funding model frequently asked questions (FAQs) | NIHR RDN.

 

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