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Clinical trials

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Additional considerations for single or multi-centre trials

8 December 2022Ensure the correct process is followed depending on whether it is a single or multi-centre trial sponsored by an NHS organisation

Assuring Investigational Medicinal Product (IMP) supply

22 September 2022Sponsor pharmacy role regarding the supply assurance of Investigational Medicinal Products (IMPs) in CTIMPs

Clinical Trials

Advice and guidance to support the provision of pharmacy clinical trials services.

Closing clinical trials

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

Constructing a pharmacy manual for clinical trials

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

Costing Clinical Trials of ATIMPs using the NIHR iCT - Advice for Pharmacy Sites

12 July 2022Guidance to support and promote consistent pharmacy costing for commercial clinical trials involving ATIMPs.

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

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

Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites

16 September 2022A 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

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
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