Clinical trials

Site readiness and guidance

Advice on costing advanced therapy clinical trials and guidance to ensure institutional readiness at sites.

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Online Article
12/07/2022

Costing Clinical Trials of ATiMPs using the NIHR interactive Costing Tool – Advice for Pharmacy Sites

Advice produced by the Pan UK Pharmacy Working Group for ATMPs for Pharmacy sites on costings for clinical trials of ATMPs, using the NIHR interactive costing tool.
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Online Article
04/12/2020

Diagnosis and medical management of acute CAR-T cell toxicities in adults

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.
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Online Article
21/07/2020

Ex Vivo (cell based) gene therapy medicinal products – pharmacy institutional readiness guidance

Ex vivo gene therapy medicinal products are ATMPs, which require pharmacy oversight, even when being handled elsewhere within a healthcare organisation. This document produced by the Pan UK Pharmacy Working Group for ATMPs outlines the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any ex vivo (cell based) Gene Therapy Medicinal Product (GTMP)
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Example risk assessment for proposed activities involving; Gene Therapy Medicinal Products (GTMPs) or Gene Therapy Investigational Medicinal Products (GTIMPs)

An example risk assessment used to fully review the risk posed by GTMP/GTiMPs in preparation for submission to local genetic modification safety committee
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pdf
22/09/2022

Feasibility and risk assessment for all clinical trials

Template for the feasibility and risk assessment of all clinical trials (not just ATIMP)
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Online Article
30/10/2019

Gene Therapy Medicinal Products – Governance and Preparation Requirements

A Pharmacy Working Group for ATMPs resource. Pharmacy is often the first port of call when an organisation wishes to use a gene therapy and needs to provide pragmatic guidance to facilitate the introduction of these innovative products. This document is designed to give practical advice to centres wishing to undertake gene therapy trials and need to understand the requirements and recommendations for governance and, in particular to have in place a Genetic Modification Safety Committee. The document also gives practical advice for centres to help them understand operational requirements including deciding the optimal location for preparation.
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Online Article
01/01/2020

Guidance on Pharmacy oversight and Pharmacist Supervision of licensed ATMPs requiring a preparation/reconstitution step

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs, providing definitions of oversight and supervision and clarifies where each are required when implementing Advanced Therapy Medicinal Products
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Online Article
16/10/2020

Handling Dry Ice and Vapour Phase Nitrogen Shippers – Advice for Hospital Pharmacies

A Pan UK Pharmacy Working Group for ATMPs resource. Some medicines, including many ATMPs, achieve greatest stability at ultra-low temperatures. Therefore the use of -80°C and below is commonplace to achieve optimal product shelf-life. As the usage of ATMPs is increasing, Pharmacy departments are becoming required to receive shipments and to store products at ultra-low temperatures
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Online Article
01/07/2020

In Vivo (virus based) gene therapy medicinal products – pharmacy institutional readiness guidance

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.
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Online Article
15/09/2022

Operational implications of UK Exit from the EU – Guidance for NHS Pharmacy Clinical Trial Sites

Guidance produced by the Pan UK Pharmacy Working Group for ATMPs regarding the operational implications of the UK exit from the EU for NHS Pharmacy clinical trial sites, including ATiMPs
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Online Article
14/11/2022

Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries

This guidance produced by the Pan UK Pharmacy Working Group for ATMPs describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services.  The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.
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Online Article
01/01/2020

Pharmacy institutional readiness for marketed CAR-T therapy: checklists for pharmacy services

A Pharmacy Working Group of ATMPs resource. CAR-T treatments require governance and management by Chief Pharmacists. They present risks which Chief Pharmacists should ensure are minimised. Whilst collaboration with expert cellular product handling colleagues will be key operationally, it may present challenges for Pharmacy to embed this new working relationship
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pdf
30/04/2020

Pharmacy/Pathology Management of Cellular Therapy Products (CTPs) as Advanced Therapy Medicinal Products (ATMPs)

To describe the procedure for managing CTPs used as ATMP which are manufactured outside The Christie NHS Foundation Trust, received, stored and issued by The Stem Cell Laboratory at The Christie Pathology Partnership which has been prescribed by an appropriate prescriber
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pdf
06/04/2021

Self Assessment questionnaire to perform the storage and release of ATMPs on behalf of Pharmacy

Self-assessment questionnaire to assess regulatory compliance in The Christie Pathology Partnership Laboratories to perform the storage and release of ATMPs
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Online Article
01/07/2020

Somatic cell therapy medicinal products – pharmacy institutional readiness guidance

The purpose of this document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where Chief Pharmacists should focus pharmaceutical expertise prior to an organisation implementing any Somatic Cell Therapy Medicinal Product (sCTMP). This document presents a flow diagram outlining a stepwise approach to implementing processes to prepare and administer sCTMPs. It is followed by checklists which relate to the various steps presented in the diagram
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  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

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    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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