UK Guidance for Study Set-Up
The latest guidance for clinical trial sites to speed up study set-up times.
The UK Government, working with the Devolved Administrations in Scotland, Wales and Northern Ireland, is committed to accelerating clinical trial set-up times to under 150 days to enable faster, more predictable trial delivery and improve patient access to innovative treatments. All participating sites are expected to deliver against this target (see UKCRD policy statement and FAQs).
This forms part of a wider programme of UK clinical trial reform, designed to drive efficiency and predictability across the research environment.
This page sets out the guidance and policies for study set-up that sites should follow to achieve this. For commercial contract research studies in England, the NHS national directive mandates the processes NHS Trusts must use.
For country specific support, visit Homepage | Health Care Research Wales | Home | NHS Research Scotland | NHS Research Scotland | Public Health Agency – Research & Development in Northern Ireland |.
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Oversight, workforce and finance readiness
Applies to all study types in NHS Trusts in England.
Sites should put in place board-level oversight of research delivery, ensure sufficient workforce capacity to support study set-up and delivery, and follow NHS England guidance on staffing and research finance, including timely cost recovery arrangements.
- Read the NHS England guidance on Board Oversight and Staffing (May 2025 PDF)
- Access the NHS England guide to Managing Research Finance (external website) NHS England guidance has been recognised by NHS Research Scotland.
- Review the letter on Supporting National Ambitions and the 150-day target (November 2025 PDF)
- Download the Medium Term Planning Framework 2026/27 to 2028/29 (PDF)
Contracting
Applies to all study types, UK-wide.
Sites should use the relevant central model agreements, where applicable, and should not amend them locally.
Guidance links:
Non-commercial costing
Applies to non-commercial studies, UK-wide.
Sites should use the Schedule of Events Cost Attribution Tool (SoECAT) and required supporting documents for all relevant non-commercial studies.
Commercial costing
Applies to commercial contract studies, UK-wide.
Sites should follow the National Contract Value Review (NCVR) principles and process for all commercial contract research.
- Visit our National Contract Value Review (NCVR) process improvement page
- Visit the NHS Accelerated Access Collaborative for the National Contract Value Review (external website)
Nation-specific guidance:
Health Research Authority (HRA) policies and guidance
Applies to all eligible study types, UK-wide.
Sites should rely on study-wide assurances where available and align with HRA guidance, including pharmacy, radiation, information governance, and IR(ME)R interpretation guidance.
Data reporting
Applies to all studies, UK-wide. In England, Government level performance reporting against this metric only applies to commercial interventional clinical trials and the NHS Outcome Framework metric applies to all clinical trials in England.
Sites should record the 90-day site-level part of the 150-day target set-up milestones using the agreed definitions and processes.
- View the live NHS Trust Study Set-up dashboard (external plaform)(Note: To align with UKCRD reporting, navigate to the ‘90 days’ tab and select ‘UKCRD Selections’)