Study Set-Up Plan: Phase 1 Completed

Published 28th April 2025

UKCRD has published a policy statement announcing the new Study Set-Up Plan, led by the Department of Health and Social Care (DHSC) on behalf of the four UK nations, to rapidly address the delays affecting clinical research through digitalisation and reducing unnecessary bureaucracy. 

At the beginning of April, delivery partners from across the system presented this new Study-Set Up plan in a webinar that took place earlier this month, which was attended by approximately 1,100 people. You can learn more about the Study Set-Up Plan via the webinar recording. 

The Study Set Up plan was agreed at the UKCRD Oversight Board on 11 February 2025, since then, the plan has reached its first delivery milestone today. Below are key deliverables highlighting the initial improvements to streamline and accelerate study set up across the UK. System Partners (NHS England, The Health Research Authority, National Institute for Health and Care Research, Medicines and Healthcare Regulatory Agency) on behalf of all four UK nations have committed to delivering this plan at pace and are pleased to share the following progress:

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

• We have 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. 

• We have launched a pilot with The Experimental Cancer Medicine Centres Network to test a streamlined study set-up pathway and mandated UK Pharmacy Assurance. This pilot seeks to develop a new process which aims to remove duplication of UK study-wide reviews and improve the use and impact of pharmacy technical review information.

• We have developed a policy paper for the proportionate interpretation of the current Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) and initiated discussions with the Care Quality Commission (CQC) to seek their endorsement. This is the first step in providing clearer guidance on the interpretation of the regulations, reducing unnecessary duplication and bureaucracy, whilst ensuring patient safety and compliance with the regulations.  

• The HRA have shared an update on their previous blog on Information Governance, outlining the 3 prioritised steps the HRA will be undertaking to improve confidence in UK study-wide reviews for Information Governance to streamline checks during study set-up.     

DHSC along with System Partners have overseen and continue to work at pace through the UKCRD programme towards delivering key interventions through to June 2025, which will mark the next phase of the Study Set-Up Plan.