Site Setup Projects

Study setup Standard Operating Procedures (SOPs) were assessed, aligned to the Health Research Authority (HRA) Assess, Arrange, Confirm procedure – when the site is formally invited to assess capacity and capability through to site confirmation. 

SOPs were provided by partners who had one, and key activities and next steps were assessed.  This was also informed by other emergent information such as The Clinical Trials Best Practice Guide 2024 (Shelford Group/ABPI [1]), feedback gathered via the BHP Reducing Bureaucracy Survey [2] and the CRN Sponsor Survey [3]. 

We identified that while the NHS worked to the mandated national process, there was substantial variation in the information, detail, timing of steps and supporting materials. A review of HEI processes offered opportunities to align to external processes and reduce delays. 

Recommendations were made to create sector-leading alignment:

• Recommendation 1: establish a common data system to ensure a single accurate tracking process for BHP clinical trials
   

• Recommendation 2: develop unified SOPs for BHP NHS sites, aligning processes and providing consistency to ensure best practice
   

• Recommendation 3: align SOPs within University of Birmingham to bring clarity in roles, responsibilities and timelines for activities
   

These have received approval from members of the BHP board (NHS Chief Executives and Board Chairs and University Vice-Chancellors), the BHP executive (NHS Chief Medical Officers and University Head of College/ Deputy Vice-Chancellors), as well as commitment from R&D Directors and Managers

A workshop was held on 9 January 2025, sponsored by University of Birmingham and with facilitation by the Regional Research Delivery Network (RRDN – former Clinical Research Network West Midlands) and engagement by the Health Research Authority.

The event brought together peer group members, their operational leads and key representatives from across partners, focussed on solutions that translate nationally i.e. sector-wide (not BHP specific).  

The aims of the day were to:

• Establish a shared understanding of current processes

• Identify opportunities with potential to improve setup times

• Agree next steps to support the recommendations
   

We gained commitment to;

• Continue process mapping efforts, increasing communication and genuine co-development of trial documents between NHS and HEI

• In the absence of a national model, develop a BHP NHS academic grants costing model

• Explore digital systems to support project management tools, facilitate increased/automated updates and document sharing

• Consider BHP tools which support communication, engagement and dissemination of programme outputs

Read more here.