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Service advice and planning

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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

Archived model policy for NHS COVID-19 vaccine handling and management

17 December 2020A model policy to enable organisation to implement good governance in the safe and secure handling and management of COVID-19 vaccines.

Assurance of aseptic preparation of medicines

13 January 2023Updated guidance from NHSE to reflect governance and visibility of the assurance and audit of unlicensed aseptic preparation

Assuring Investigational Medicinal Product (IMP) supply

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

Bank and agency staff and Patient Group Directions

25 February 2020The below summarises the advice on the use of PGDs by bank and agency staff working within organisations.

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

DS 21/75 Prescription Charges for Drugs Given to Patients in Clinical Trials (Department of Health and Social Security, 1975)

2 April 2019In 2019, this remains the only known documented government guidance to the NHS on the subject.

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

Guidance on Definition of Supervision under Section 10 Aseptic Preparation Activities, 3rd Edition, Sep 2019 (Yellow Cover)

3 September 2019The NHS Aseptic Services Accreditation Working Group, working closely with the South West Product Approval Accreditation Programme have developed and published a definition of Supervision…