Pharmacy assurance pilot
This targeted pilot streamlines and strengthens pharmacy technical assurance in early-phase oncology trials.
About the pilot
We’ve worked with the Health Research Authority to develop this pilot. It stems from the Study Set-Up Project and the UK Clinical Research Delivery programme.
The pilot aims to:
Apply across all our network centres, for both commercial and non-commercial early-phase oncology trials (excluding healthy volunteer studies).
Reduce duplication and variation in pharmacy reviews, improving efficiency and consistency.
Provide clearer guidance on information needed from sponsors and sites during selection and set-up.
Support better coordination through early engagement of pharmacy and research and development teams, and enhancements to the current technical review form (including Advanced Therapy Medicinal Products, genetically modified organisms, and transport logistics).
Improve management of amendments within the assurance process.
Useful resources
Guidance on setting up clinical trials
This guidance sets out clear steps for setting up clinical trials, focusing on collaboration between sponsors, sites, and pharmacy departments. (PDF, 504 KB)
Summary of the guidance
This document provides an accessible summary of our draft guidance on setting up clinical trials. (PDF 158 KB)
Pilot information sheet
This information sheet provides details on what the pilot involves and how to participate. (PDF 206 KB)
Guidance for amendments, changes and adding sites
This guidance provides support for sponsors, sites and pharmacy departments to handle changes to clinical trials. (PDF 188 KB)
Additional resources
This presentation provides useful tips and information for sponsors and sites. (509 KB)
Key contacts
Experimental cancer medicine centres
For general information related to our role in the pharmacy assurance pilot, please contact our Project Manager, Neil Bhattacharjee.
Email neil.bhattacharjee@cancer.org.uk
Health Research Agency
For information related to joining the pilot, please contact the HRA.
Email pilot.testing@hra.nhs.uk
Pharmacy Technical Assurance
For support related to pharmacy technical assurance please contact the HRA.