Immune effector cell therapy – eLearning Module

NHS Readiness Toolkit

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Online Article
17/11/2021

A quick reference guide to preparing and infusing frozen stem cells

A quick reference guide to preparing and infusing frozen stem cells.
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Online Article
27/02/2023

ABPI Roadmap

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring
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Online Article
31/03/2021

Accelerated Access Collaborative (AAC)

The AAC is bringing together industry, government, regulators, patients and the NHS to remove barriers and accelerate the introduction of ground-breaking new treatments and diagnostics which can transform care, including ATMPs
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pdf
18/10/2021

Adult CAR T Cell Shared Care Guidelines

This exemplar guideline suggests roles and responsibilities between CAR T cell referring centres and treatment centres. It also outlines common late adverse effects that may occur when patients have returned to their referring centre.
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Online Article
27/01/2022

Advanced therapy investigational medicinal product (ATIMP) clinical trials – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user a refresher of standard clinical trial studies and explains the additional features which impact on the design of trials for investigational advanced therapy medicinal products (ATIMPs) and how they can be addressed. Roles and responsibilities, governance and sources of support for ATIMP clinical trials are also outlined.
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pdf
14/07/2022

Aide Memoire – Procurement Site Qualification

A guidance checklist for NHS staff in preparation for ATMP starting material procurement site qualification. This document would be best utilised when beginning to set up a service for procurement of a new cell or tissue type but could be used as a checklist for existing cell or tissue type procurement
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pdf
27/02/2023

All CAR-T follow up checklist

Please click here for CAR-T follow up checklist
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pdf
23/08/2022

Ambulatory Care for Lymphodepletion Prior to CAR-T Cell Infusion

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust to provide a safe and effective framework by which lymphodepletion can be performed in the outpatient setting, prior to admission for CAR-T Cell infusion.
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pdf
02/10/2023

Apheresis Horizon Scanning Infographic: Examining current & future demand for apheresis services

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pdf
01/06/2020

Apheresis process flow

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis
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pdf
27/02/2023

Apheresis Training and Competency Manual

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.
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pdf
27/02/2023

Apheresis Weekly Cleaning Log

A template of an apheresis weekly cleaning log.
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pdf
23/08/2022

Assessment of Suitability for Ambulatory Care BMT at BHOC

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust detailing the inclusion and exclusion criteria when referring patients to the Ambulatory Care (AC) BMT service.
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pdf
02/02/2022

ATiMP Clinical Trials Quality Technical Agreement Guidance

A guidance document providing an oversight of the purposes and contents of a Quality Technical Agreement (QTA) for use between advanced therapy clinical trial Sponsor and Participating Organisation. The document set outs a proposed standardised format for advanced therapy clinical trial QTA with example roles and responsibilities.
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xlsx
27/02/2023

ATIMP Feasibility Questionnaire FAQ Database Template

A template produced by The Christie NHS Trust to hold and update frequently asked questions and responses to cell therapy trial feasibility questionnaires.
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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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