Trial governance

Trial governance

Information regarding the governance arrangements 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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pdf
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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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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pdf
03/03/2022

British Pharmacopeia MHRA White paper detailing the Flow Cytometry framework for ‘Good Practice’

A British Pharmacopeia whitepaper for the application of flow cytometry for the cell and gene therapy community.
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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
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
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
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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pdf

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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Online Article
27/02/2023

HRA – a guide to managing projects via combined review

For new for new Clinical Trials of Investigational Medicinal Products (CTIMPs) and combined IMP/device trials. A step by step guide on how use use IRAS for a combined review.
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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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Online Article
27/02/2023

HRA Consent and patient information guidance and templates

The Health Research Authority's (HRA) online guidance to share best practice on consent and participant information by providing examples and templates.
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Online Article
27/02/2023

HRA Consent and patient information guidance and templates – Researchers and Ethics Committees

The Health Research Authority's online guidance for researchers and ethics committees on consent and how to prepare materials to support this process.
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Online Article
27/02/2023

Integrated Research Application System (IRAS) – preparing and submitting applications

Advice on preparing and submitting applications on Integrated Research Application System (IRAS).
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Online Article
28/11/2022

ISBT 128 labels for advanced therapies – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.
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Online Article
27/02/2023

NIHR Clinical Trial Routemap

The NIHR Clinical Trial Routemap is an interactive colour-coded tool to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The routemap distinguishes between legal and good practice requirements and indicates which aspects of these are relevant to wider clinical research in general. It includes an overview of trial practices along with more detailed information available at ‘stations’ along the route.
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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

    Read more about this section.

    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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