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Clinical trials

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Ex-Vivo (cell based) GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing Ex-Vivo genetically modified organism (GMO) Gene Therapy.

In-Vivo GMO Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

20 March 2025This document outlines key areas for focus of pharmacy expertise prior to an organisation implementing In-Vivo Genetically Modified Organism (GMO) Gene Therapy.

How to undertake an audit of a cell therapy laboratory

18 February 2025A guide to performing audits of cell therapy laboratories where receipt, storage and handling of cell-based ATMPs has been outsourced by the Pharmacy department

Outsourcing ATIMP Handling: A Template Technical Agreement

7 February 2024A Template Technical Agreement for outsourcing the Receipt, Storage, Preparation and Onward Supply of ATIMPs for Clinical Trial Sites

Pharmacy Manual Checklist for Clinical Trials for ATIMPs

2 March 2023Pharmacy Manual content expectations for optimal site implementation of ATIMP Clinical Trials.

Closing clinical trials

12 December 2022Sponsor pharmacy responsibilities during trial closure and the final monitoring visit

Monitoring and auditing clinical trials by participating sites

12 December 2022An overview of the Sponsor Pharmacy's responsibilities for monitoring and auditing a clinical trial as part of participating site management

Constructing a pharmacy manual for clinical trials

12 December 2022Sponsor pharmacy must construct a pharmacy manual when required by sites hosting clinical trials

Feasibility and setting up of clinical trials at participating sites

12 December 2022An overview of the Sponsor Pharmacy's responsibilities during setup of a clinical trial as part of participating site management

Risk assessing Investigational Medicinal Products (IMPs)

12 December 2022Sponsor pharmacy responsibilities when assessing the risk associated with CTIMPs