National infrastructure, templates and guidance

National infrastructure, templates and guidance

National infrastructure, templates and guidance

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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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Online Article
26/01/2021

Cell and Gene Therapy Insights Paper on Best Practice in Flow Cytometry

This paper highlights the major themes found in designing and applying flow cytometric analysis for cellular therapies and discusses practical solutions to common problems
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docx
27/02/2023

Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTa) for investigational Advanced Therapy Medicinal Products

Model Clinical Trials Agreement - This model agreement captures all the specific contractual requirements of ATMP commercial clinical trials for implementation in the NHS.
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Online Article
27/02/2023

Clinical trials for medicines: apply for authorisation in the UK

Government advice on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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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
27/02/2023

EMA – Clinical Trials Information System, Training and Support

Training and supporting materials provided by the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS).
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Online Article
27/02/2023

EMA – Clinical Trials Regulation

Information provided by the European Medicines Agency (EMA) on the European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation, entered into application on 31 January 2022.
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Online Article
16/03/2021

Evaluation of institutional readiness at sites within the UK NHS using a novel advanced therapy medicinal product assessment tool

This publication reports on a study to assess institutional readiness (IR) of NHS sites that form part of the Northern Alliance Advanced Therapy Treatment Centre to deliver advanced therapy medicinal products, and discusses the development of an assessment tool to support self-assessment of IR in healthcare institutions
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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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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
01/10/2020

Governance and operational considerations for delivering ATMPs in hospitals – Webinar

This training webinar gives an overview of the preparations required prior to treating patients with ATMPs
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docx

Guidance – Model Clinical Trial Agreement and Clinical Research Organisation Model Clinical Trial Agreement

This guidance documents accompanies the ATMP model clinical trials agreement and can be use as a guide to allow the proper use of the model agreements.
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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
31/03/2021

Guidance on the use of genetically modified microorganisms in a clinical setting

HSE (Health and Safety Executive) guidance to help organisations to choose the most appropriate regulatory procedure, particularly those wishing to undertake studies involving the administration to humans of substances based upon genetically modified microorganisms (GMMs)
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Online Article
27/02/2023

HRA – Preparing Study Documentation

When applying for HRA Approval you will need to check what supporting documents you will need to provide well in advance of when you expect to submit your application. This will avoid unnecessary delays to your application. This page details the required supporting documentation.
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  • Advanced therapy clinical trials process overview

    Advanced therapy clinical trials process overview

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    This section features The NIHR Clinical Trials Toolkit and The ABPI ATMP road map

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  • Trial Governance

    Trial Governance

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    Information regarding the governance arrangements required within the NHS to approve, set up and manage clinical trials of advanced therapy investigational products is included here, with details on local governance, committees, feasibility and risk assessments.

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  • Procurement of Starting Materials

    Procurement of Starting Materials

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    Information and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:

    • Solid tumours A suite of SOPS by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (Tils)
    • Blood (aphaeresis) A suite of SOPS for adoptive cellular therapy (Immune Effector Cells)

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  • Receipt, storage & issue of advanced therapies

    Receipt, storage & issue of advanced therapies

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    Available here are examples of checklists and templates for the safe receipt, storage and issue of advanced therapies within the NHS.

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  • Pharmacy considerations

    Pharmacy considerations

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    The considerations for hospital pharmacy departments delivering advanced therapies, including:

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  • Clinical management of patients at site

    Clinical management of patients at site

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    Includes exemplar SOPs and information regarding the clinical management of patients receiving advanced therapies in a hospital setting, covering patient consent, treatment, management of toxicities and follow-up care.

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  • Education and training

    Education and training

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    This section includes links to webinars, e-learning modules and a range of resources, to assist all staff delivering advanced therapy trials in an NHS setting.

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  • Performance management and metrics

    Performance management and metrics

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    An outline of the barriers to effective advanced therapy clinical trial set up, changes to overcome these barriers, and the key metrics to measure success in terms of trial set up and patient referral and recruitment is available here.

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  • National infrastructure, templates and guidance

    National infrastructure, templates and guidance

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    Links to information on the national infrastructure surrounding the clinical trial application process, also further guidance, and templates to assist in the set up and delivery of advanced therapy clinical trials. Including examples of model ATiMP clinical trial agreements.

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    • Explore all toolkit sections

  • 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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