Study Set-Up Plan: Phase 2 Completed

Published 30th June 2025

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

30th June marks the final milestone of this Study Set-Up Plan. Together with System Partners (NHS England, The Health Research Authority, National Institute for Health and Care Research, Medicines and Healthcare Regulatory Agency) we are pleased to share the following progress:

• DHSC and NIHR issued:

• Notice that the attributions in the authorised SoECAT, submitted as part of the study documentation for study approval, cannot be modified at local level. 

• Notice for UK non-commercial sponsors and sites to use the existing template UK contracts and study agreements, without modification, for studies on the NIHR RDN Portfolio, whilst work will continue to align these improvements across the devolved nations.

A bulletin with more information can be found here.

• The pilot launched with the Experimental Cancer Medicine Centres Network to test a streamlined study set-up pathway and mandated UK Pharmacy Assurance is ongoing, the associated guidance for Pharmacy has been published and expression of interests for studies to pilot this are underway. More information and how to take part can be found here.

• The HRA are collaborating with the Information Commissioner’s Office to ensure alignment of guidance to the community and have published an additional blog providing an update on Information Governance improvements which outlines next steps to improve confidence in UK study-wide reviews for Information Governance to streamline checks during study set-up. 

• We have published a monthly report alongside the UKCRD Key Performance Indicator Report to provide an additional monthly snapshot of site-level commercial study set-up performance.

• The community has highly anticipated the work to formalise early sponsor and site negotiations with the development of a new Site Selected Agreement. HRA leading the development of this work, have undertaken initial discovery work and together with the devolved nations will be consulting on options and inviting feedback. More information will be shared on this here soon. 

• Work also continues with the development of a clarifying statement on the interpretation of current Ionising Radiation (Medical Exposure) Regulations. With initial steps undertaken to support clarifications with the Care Quality Commission. More information will be shared on this here soon. 

Next Steps

The Study Set Up Plan was developed to take rapid action to achieve system level improvements. Although we have 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.

The successful implementation of the plan will be closely monitored for impact. Monitoring will be undertaken by DHSC and partners through focused stakeholder engagement through workstream task and finish groups and collaboration and wider communications through the UKCRD programme governance structures. NHS England will mandate the use of the new processes and templates for commercial trials by October to fully embed them across the NHS.

Under the UKCRD Programme, we will continue to work closely with devolved nation partners to ensure processes are compatible and improvements benefit the whole of the UK.

Following the success of the webinar we held in April, we plan to host an additional webinar in September to provide further information and updates.

We would like to thank colleagues across the sector for their continued support with this work to collectively drive to make the UK a world leader in clinical research.