Clinical trials
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Operating as an NHS clinical trial site post EU Exit
11 February 2026A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland.
Product design considerations for optimising ATMP implementation
11 February 2026This guidance provides advice for ATMP developers, highlighting implementation challenges faced by the NHS and suggesting design consideration to minimise them.
Outsourcing ATIMP handling: A template technical agreement
11 February 2026A template technical agreement for outsourcing the receipt, storage, preparation and onward supply of ATIMPs for clinical trial sites.
Undertaking an audit of a cell therapy laboratory
11 February 2026A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the pharmacy department
Supply of aseptically prepared IMPs across legal boundaries
19 November 2025The legal and practical implications when transferring aseptically prepared Investigational Medicinal Products (IMPs) across legal boundaries.
Pharmacy manual checklist for clinical trials for ATIMPs
2 March 2023Pharmacy manual content expectations for optimal site implementation of ATIMP clinical trials.
Clinical Trials
Advice and guidance to support the provision of pharmacy clinical trials services.