The Study Intensity Tool (SIT) is a standardised resource for clinical research teams, designed to support consistent planning of workforce, resources, and costing across studies. It is widely used by CRFs and research teams across the UK, providing a practical and transparent way to understand study intensity, allocate staff effectively, and plan resources efficiently.

Built by CRFs, for CRFs, the SIT is fully adaptable for different team structures and study designs, making it suitable for a wide range of clinical research settings. Whether you are running a simple observational study or a complex interventional trial, the SIT helps teams assess staffing requirements, workload distribution, and costing needs in a standardised way.

The tool documents activity across nursing, laboratory, imaging, and up to four MDT staff groups, as well as administrative roles, ensuring a comprehensive view of the resources needed to deliver a study successfully. It provides a practical framework to:

• Calculate workforce requirements using WTE and WTE per annum
• Assess study intensity per visit and overall workload for a study
• Capture administrative and protocol-driven activities
• Provide transparent costing and staffing evidence for feasibility assessments, budgeting, and study review

The SIT workbook consists of eight pages:

• SIT Page 1–5: study activity pages, including recruitment and MDT involvement
• Admin: capture administrative and nursing admin activity
• Summary: overall study intensity, staffing, and costing
• Support: guidance, resources, and links for further support

The latest version, SIT v14 (December 2025), brings several enhancements while keeping the core calculations consistent with V13:

• Adult and Paediatric integration: One workbook, change between participant types easily
• Improved usability: Streamlined layout, colour coding aligned with UKCRF branding, frozen headers, and minimisable sections
• Enhanced summary page: Pulls together all WTE, intensity, and costing data across pages and staff groups
• Administrative improvements: Includes a dedicated nursing admin section, updated procedures, and clearer guidance to avoid double counting
• Updated procedure timings: Aligned with national guidelines
• Note: At launch, V14 cannot yet be uploaded to CRFManager®. Sites that require CRFManager® compatibility should continue to use V13. Please join the waitlist, and we will notify sites when V14 upload becomes possible.

• Efficiency: Quickly assess study demands across multiple disciplines
• Accuracy: Standardised WTE and costing calculations
• Flexibility: Adaptable for different teams, studies, and protocols
• Community-led: Developed collaboratively by CRFs
• Transparency: Provides clear evidence for workforce planning and feasibility assessments

• Existing users: v14 Summary of changes
• New users: Beginner training (tool demonstration to come)
• More bite sized videos on various topics to come!

• The tool can be downloaded using the button above, or if this doesn’t work, via the UKCRF Network Portal
• Summary of Changes document: overview of v14 updates
• Demo SIT: take a look at the test demonstration SIT that is used as an example in the demonstration video (COMING SOON)
• Monthly Q&A Webinars: Request the calendar invites using this MS Form. Dates will also be sent to your CRF Manager and Senior/Lead Nurse.
• Contact: [email protected] for questions or guidance

Thanks to the UKCRF Network Study Intensity Tool Group for developing and maintaining the SIT. Their work, informed by real-world CRF feedback, ensures the tool meets the needs of research teams across the UK.