Study Set-Up Plan: Questions

Published 22 September 2025

Introduction

The Study Set-Up Plan, led by the Department of Health and Social Care (DHSC) on behalf of the four UK nations, has been delivered through the UK Clinical Research Delivery Programme (UKCRD) – a cross-sector programme of work that brings together key stakeholders to achieve the comm on aim to offer a world-leading environment for life sciences to undertake research across the UK. 

At the beginning of April, delivery partners from across the system presented this new Study-Set Up plan in a webinar Streamlining and reform of study set-up. 

DHSC, along with System Partners (NHS England, Health Research Authority, National Institute for Health and Care Research, Medicines and Healthcare Regulatory Agency and the Devolved Administrations Health Departments) have responded to the most frequently asked questions about the Study Set-Up Plan. 

 While activity has progressed since presenting this webinar and we have now reached the final milestone of this current plan, streamlining and reforming the set-up and delivery of clinical trials remains a key priority for the UKCRD programme. We will be continuing to engage and collaborate with the system under the UKCRD programme, and you can stay up to date on latest progress at UKCRD.org.

If you have any additional questions or want to learn more, please contact the Study Set-Up Team at UKCRDprogramme@dhsc.gov.uk 

General Questions about the Study Set-Up Plan

Q: Who informed the development of this plan and are there opportunities to still get involved?

A: We worked closely with stakeholders across the clinical research system through intensive consultation and engagement to identify barriers contributing to study set-up delays.

Including: National Institute for Health and Care Research (NIHR), NHS England (NHSE), Health Research Authority (HRA), Devolved Administrations Health Departments, the UKCRD Programme Committees, UK R&D and The Association of the British Pharmaceutical Industry (ABPI) fora to determine the root causes of set-up delays and also incorporating the success of the UK Vaccine Innovation Pathway (VIP) accelerated delivery pilot learnings.

Acceleration work continues across the system, and we would like to hear your thoughts and feedback. If you would like to get involved, please contact the UKCRD programme using the contact details at the end of this document.

Q: Is this plan for both commercial and non-commercial studies?

A: Yes, the work of the Study Set-Up Plan looked closely at both commercial and non-commercial studies. Set-up activities happen in parallel for both the commercial and non-commercial portfolio, and to make the biggest impact we must drive efficiencies and improvements to the whole process across the portfolio. 

Q: Are there more workstreams planned in the future, and will these support both commercial and non-commercial research? 

A: We know no single action will resolve delays in study set-up. These workstreams are supported by a wider suite of complementary activity looking at both commercial and non-commercial studies. We are now scoping future work to support the Study Set-Up Plan to help support the Prime Minsters ambition to turbocharge clinical research, to fast-track clinical trials and reduce set-up time to less than 150 days by March 2026.

Q: How can we follow the progress of the Study Set-Up Plan? 

A: You can stay up to date on the latest progress of the Study Set-Up Plan and other related activities at UKCRD.org. Here you can find UKCRD’s monthly UK Clinical Research Update as well as our site-level reports. 

Q: How is the Study Set-Up Plan addressing capacity and resource restraints?   

A: This Study Set-Up Plan is designed to remove unnecessary duplication and bureaucracy to free up capacity for our vital workforce.

In May, NHS England wrote to NHS leaders including Finance and R&D Directors of NHS providers reminding them to comply with terms and conditions attached to any research income outside of NHS HM Treasury allocations, and use this funding for its intended purpose including recruiting to research and development posts. NHSE are running roundtables with Trust Directors to discuss how better to support implementation of the NHSE research finance guidance and what further development it may need. These conversations have a focus on invoicing and cost recovery to further support capacity and resource building.

Questions about Workstream 1

Develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation and remove duplication of activity that can be done once on a per study basis during study set-up.

Q: When will new agreement templates be available for use and what should we do if organisations try to modify these?

A: Latest templates for use are available via IRAS help. Visit HRA Now - Health Research Authority for more information. 

On 28th April 2025:

• We published a new model Commercial Chief Investigator Agreement (mCCIA) which aims to reduce unnecessary negotiation during contracting. 

• We notified Commercial Sponsors wishing to enter into a Confidential Disclosure Agreement (CDA) with prospective NHS research sites, that an unmodified model CDA must be used to cut unnecessary duplication and streamline contracting. 

On 19th May 2025:

• We updated model commercial agreements to clarify NCVR-negotiated and non-NCVR-negotiated costs, we know have been causing disruption during site set-up.

On 20th June 2025:

• Following early feedback on the mCCIA, we published a revised version, allowing greater transparency and flexibility in the annual CI services procured, as well as publishing a version of the template suitable for unmodified use with CRO involvement.

 If an organisation seeks to use a bespoke or modified commercial agreement, where an appropriate UK template agreement exists, they should be referred to this Q&A webpage and other guidance relevant to the UK policy expectation of unmodified use.  Where an organisation maintains that no suitable UK template agreement exists for its purpose, that it cannot enter into a UK template without modification for reasons specific to it or its study, or has any other concerns about the policy expectation, they should be directed to research.agreements@hra.nhs.uk. NHS England will mandate the use of the new processes and templates for commercial trials by October to fully embed them across the NHS in England.

Q: How will introducing a new site / location selected agreement between Sponsor and Sites streamline study set-up?

A: The intention for the proposed site/location selected agreement is two-fold:

1. To place on a formal footing the key decision of site selection, as part of wider work to standardise the actions needed from sponsors and sites to set-up and deliver research, thereby ensuring that the right information is available, to the right people, at the right time in a nationally consistent way.  This will facilitate meaningful agreement that a site has the capability to deliver a particular research study, allowing the parties to then commence putting in place the capacity to deliver.

2. To provide a consistent means of sharing key information and expectations relating to the site and sponsor and the specific study, such as key timepoints, contact and escalation mechanisms and the way in which the parties will work together to deliver the study, thereby avoiding confusion, duplication and delay.

We are still working with the research community to further develop our thinking on the function and content of this document, as well as the wider process within which it will sit.  This includes exploring whether the document should have the legal force of a contract or serve as a letter of intent,  as well as whether the agreement should include the option of financial incentives for hitting agreed timepoints and/or ensure cost recovery of set-up costs incurred where site initiation does not complete. 

 We welcome all contributions to this ongoing conversation, including from sponsors and CROs keen to engage in early testing and piloting, please contact alastair.nicholson@hra.nhs.uk  

Q: Will the site / location selected agreement include incentives or repercussions if the timelines are not by the sites? 

A: No final decision has yet been taken on whether the site / location selected agreement will include the option of financial incentives from the sponsor/CRO for the site/location meeting agreed set-up milestones, nor has any agreement yet been reached on whether the agreement should include arrangements for reimbursement of set-up fees should the site not conclude its set-up, through no fault of its own. We are keen to ensure  this adds value to the set up process and are testing both concepts with a broad range of stakeholders welcoming views from all, please contact alastair.nicholson@hra.nhs.uk.

Q: Why is this workstream for commercial studies only? 

A: Contracting for commercial research has been raised as a cause of confusion and delay by industry partners in a global context, distinct from issues raised by the non-commercial sponsor sector.   The baseline for commercial research from which we are able to build is different to that for non-commercial, with mandated use of model commercial agreements in place since 2018 and a long- established commercial costing model, mandated as NCVR since 2022 in England. We are also aware that the process and templates best suited for commercial processes are unlikely to be a suitable fit for non-commercial sponsors.  Our intention is to use the workstream to develop the appropriate policies, guidance and templates for commercial contract usage, with the intention of using the learning to later develop the equivalents that are best suited for non-commercial usage to support work in workstream 4 of the study set-up plan.

Questions about Workstream 2

Remove duplication of activity that can be done once on a per study basis during study set-up by making it easier to understand and accept assurance from UK Pharmacy and Radiation Technical Assurances and Information Governance study-wide reviews.

Q: Can NHS Sponsors still use their own Radiology/Pharmacy departments to provide reviews for IRAS, instead of separate HRA Radiology/Pharmacy assurances?  

A: The technical assurance process will continue to offer a self-managed option for non-commercial sponsors who choose to take part in the pilot. The reviews for technical assurance are completed in addition to IRAS and provide detailed technical information to all sites to help them set-up . Only Sponsors who choose to put a study through the pilot are required to use the pharmacy assurance process and new set-up guidance. The pharmacy pilot is testing a proposed pathway for set-up and improvements to the lead review forms used in technical assurance. We hope this will ultimately increase uptake by Sponsors and remove unnecessary duplication for sites to help set-up, where capacity is limited in these high demand clinical services.

Q: Have current capacity issues been considered when building these processes for Pharmacy? 

A: This work aims to simplify and standardise the site selection and set-up processes for both Sponsors and Sites, clarifying when decisions should be made and set-up activities should start so that capacity in pharmacy is maximised. By providing standardised pharmacy technical information to sites early, we aim to remove duplication of reviews and reduce queries later, also helping sponsors by providing early feedback for site set-up.   This work aims to enhance the effectiveness and application of pharmacy technical review information, so that local pharmacy teams can focus on the parts of set-up only they can do.

During the pilot, lead reviewers will only be chosen by the Sponsor from sites who are selected to take part, removing the need for pharmacy teams to do reviews for studies they will not set-up. We hope this will be a benefit to all sites and free up vital capacity of our workforce.

Q: How do you plan to prevent additional local checks taking place at sites during set-up and will there be an escalation process? 

A: We aim to prevent additional local checks taking place at sites during set-up by first being clear on the purpose of each step in the set-up pathway, the actions for sites and sponsors at each step, and the information needed to support them whilst identifying anything that can be done once at study-level. The focus for existing technical assurances and reviews will be on how they are best used for and during set-up. We will be working closely with R&D departments, Pharmacy, Information Governance, Medical Physics and Clinical Radiation Experts, as well as Sponsors and CROs/CTUs to help ensure all guidance is co-developed and the central reviews are impactful. For studies submitted through the pharmacy pilot, Experimental Cancer Medicine Centres (ECMC) sites and Sponsors will be supported by the central team and issues can be escalated through this. All ECMC sites are required to confirm readiness to follow the guidance and not duplicate checks pilot studies, by the end of September. It is important to note this initiative does not aim to replace essential local quality assurance or compliance activities, but we aim to remove unnecessary duplication and reduce queries at individual sites. Technical assurances for studies outside of the pilot continue to remain optional.  

Q: Will the planned improvements to Pharmacy technical assurance guidance also be informed by other trials, in addition to the planned ECMC pilot? 

A: The pharmacy technical assurance itself has been developed and already tested widely across all study types.  There is also a process in place to ensure updates can be made quickly with oversight from an expert group (UK–wide). We have updated this recently to include more support for ATMPS and GMO studies.

The pharmacy pilot will evaluate the new study set-up guidance that mandates use of pharmacy technical assurance for early phase oncology trials coming through the pilot at ECMC sites including:

• Both commercial and non-commercial trials.

• Amendments for trials previously using pharmacy technical assurance.

• Excluding trials involving healthy volunteers.

We are considering expanding the pilot through the newly established Clinical Research Delivery Centres to look at how it might help trials in hub and spoke arrangements.

All information and resources on the pharmacy pilot, including the draft guidance can be found on the ECMC website here: Pharmacy Assurance Pilot | ECMC.

Q: Are there plans for a model agreement to be prepared for using centralised services and paying for them (e.g., central radiation, central pharmacy assurance, etc.)?

A: This is not something we are looking at during the pharmacy pilot because lead reviewers will only be chosen by the Sponsor at sites selected for set-up. This means for the pilot sites, Sponsors can add payment for the lead review in their site agreement as a pass-through cost.  Workstream one is looking at the standardised contracting process where there may be opportunities to build this into other existing planned agreements and we are looking at all options for the future. 

Q: How will the HRA work with sites and individuals to improve their psychological safety to trust central reviews?   

A: The purpose of this workstream is to bring sponsors, sites and support departments together with a focus on transparency, communication and collaboration. Our central and technical reviews have been developed by those expected to use them and we will continue to do this. For technical reviews this includes pharmacists and radiation experts to provide the early technical information needed at site. Our current IG workstream involves experts in IG. We provide indemnity for our lead reviews and will continue to make this clear to sites. 

We intend to work closely with all involved throughout our pilot work and beyond. We see this as a collaboration and development process, working with all the communities, regulators and professional bodies involved, including the inspectorates. We hope by being transparent and co-creating the way forward, we will start to see more trust developing. We are working with many national bodies and groups and would welcome hearing from and with any more contacts. Many groups are starting to build strong communities of practice, which we welcome and support. HRA is always open to feedback on our processes, and we will work with sites who feel they cannot take our assurances.  

Questions about Workstream 3

Enhance the granularity of study set-up performance data by including the site-level study set-up data behind the two key performance indicators (KPIs) currently published for commercial clinical study set-up.

Q: What are the definitions for ‘Date Site Selection’ and ‘Date Site Ready to Start’ fields to support this work, and how are they being standardised?

A: Date Site Selected is the date on the sponsor email received by the site providing the minimum defined documents to enable site to commence arrangement and/or confirmation of local capacity and capability as applicable representing that the site has been selected to take part in the study.

Note: we will continue to collect HRA approval letter date as part of the data to assess the KPI at study level.

Date Site Ready to Start is the date that the site is ready to start (i.e., recruit study participants, provide data or tissue) defined by all other requirements to start, additional to contract signature and/or Statement of Activity agreement, are satisfied.

The corresponding data fields in LPMS used across the RRDN can be found in this table. Users of EDGE will note that clarification has been added to the data fields within the EDGE system.

We are continuing to identify where further refine data definitions to support standardised performance reporting. 

Q: Who is responsible for entering this data? 

A: Delivery organisations (research sites) are responsible for providing the data, in line with established requirements and processes for providing data to NIHR RDN, including DHSC’s Terms and Conditions for NIHR RDN support.

Q: Do you only plan to report study set-up performance data (KPIs) for commercial trials only?

A: Initially, this report will only cover commercial studies. DHSC are committed to increasing visibility and transparency of performance data for the entire research portfolio and plan to publish study set-up performance data for non-commercial trials in future and breaking this data down into study type.  

Q: How will this report factor where some studies are not expected to open or recruit within these timeframes? i.e. rare disease studies

A: Studies of rare diseases and other very low recruiting studies are excluded from the assessment of KPI 3 (Proportion of studies recruiting first participant within 30 days of sites opening to recruitment). These studies are also excluded from the site level reports.  

We are aware that there are instances in which the study sponsor does not wish to open a site to recruitment within the 60-day timeline e.g. not included in the first wave of site activation. These studies are still included in the data and will impact on the indicator.

We continue to work with system partners to assess how best to refine this data as this report develops.

Q: Are trusts expected to achieve these metrics at site level?

A: Yes, the Prime Minister’s announcement to turbocharge medical research in April confirmed plans to accelerate the development of medicines and therapies of the future and cut clinical trial set-up for commercial research to 150 days by March 2026. The 150-day metric is a measure of the time it takes for a single study from application for regulatory approval through to recruitment of first study participant.

To achieve this target, sites participating in a study are expected to deliver set-up activities within 90-days.

150-day metric consists of:

• up to 60 days for trials to undergo combined review;​

• up to 60 days for sites to open to recruitment from the date HRA approval received and; ​

• up to 30 days for sites to recruit first participant from opening to recruitment

Q: How will this data be used?

A: The aim of this report is to take initial steps in improving granularity of study set-up activity to support closer to real time monitoring of system performance. Publishing monthly study set-up performance by Trust is a step towards enhancing the set-up data we already publish in the UK Clinical Research Delivery KPI Reports to enable more oversight of pinch points in the set-up process and areas which require support. 

Q: Is the data being monitored in real time? 

A: Reports to track progress towards achievement of the metrics are produced monthly, the latest reports can be found here. To give sites enough time to reach and record endpoints for these indicators (60 or 30 days), a 4-month reporting lag is currently applied to this monthly report, allowing sufficient time for these timepoints to elapse and for sites to record them in the LPMS. However, we encourage sites to input data into their LPMS as close to real-time as possible. 

Questions about Workstream 4

Develop a single UK-wide costing and contracting model for non-commercial sponsored studies to reduce bureaucracy across the system.

Q: Will you be issuing guidance and information regarding the interim use of the SoECAT by non-commercial organisations to help streamline its application? 

A: Guidance for using the SoECAT is available on the NIHR website here nihr.ac.uk/online-soecat-guidance  and as part of the funder resource pack nihr.ac.uk/funder-resource-pack. These resources will be updated in line with the workstream. ACoRD training is also available through the NIHR Learn platform – please contact your regional office (Research Delivery Network or Devolved Administration office for more details).

Q: Are funders supportive of this model, as it could mean more funding for sites?

A: The workstream activities enable the collation of views from funders, and others, across the sector to explore the options and impact of this workstream.  The existing guidance for attributing the costs of R&D and the Scheule of Events Cost Attribution Tool already provide mechanisms to be open and transparent about the resource requirements of each study so that high quality research can be delivered effectively and efficiently. This workstream intends to explore further steps we can take to ensure transparency and streamlined and efficient approaches to costing and contracting non-commercial research. 

Q: How will this work impact submission at grant funding level?

A: The workstream will build on the existing process and tools and increase consistency and visibility of resource requirements and attribution for non-commercial research across the UK system.  There is a wealth of best practice available to support grant funding in the funder resource pack nihr.ac.uk/funder-resource-pack. We are also proactively engaging funders in these discussions to inform further exploratory work. 

Q: How and who will you consult for this workstream and how can I get involved? 

A: A task and finish group based on the existing Non-commercial costing and attribution group membership has been convened to support this workstream.  Additional members will be included as relevant to the activities.  Keep in touch with the latest progress or to get involved please utilise the UKCRD programme website.

Update: Notification of the compulsory use of an unmodified SoECAT, Organisation Information Document (OID) and model Non-commercial Contract Agreement (mNCA) for NIHR RDN portfolio studies was published as a bulletin by the DHSC 30th June 2025. DHSC has updated the Eligibility Criteria for NIHR Research Delivery Network Support and the Terms and Conditions for NIHR Research Delivery Network Support (ahead of further updates later this year) to clarify the position on the SoECAT, mNCA and OID use. In addition, the NIHR has updated the guidance for research funders. These can be found on the NIHR website.  (rdn.nihr.ac.uk/support-and-services/support-non-commercial) 

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