Trial Governance

Trial Governance

Trial Governance

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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
26/04/2019

ATMP Governance Structure

Governance structure organogram for supporting the introduction of ATMPs at the Christie Hospital
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pdf
22/09/2022

ATMP Risk Assessment

Risk assessment form that is the basis for assessment of capacity and capability within Manchester University NHS Foundation Trust.
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pdf
02/03/2020

Clinical trials toolbox

A summary of activities across NA-ATTC hospitals geared towards patient centred, safe and efficient trial set-up, delivery and completion
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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
22/04/2019

Exemplar Terms of Reference ATMP Education and Training Committee

Exemplar terms of reference for an ATMP Education and Training Committee at The Christie NHS Foundation Trust
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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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pdf
03/06/2019

GMO contained use authorisation procedures for clinical trial products in the UK

This guidance summarises the authorisation process for Genetically Modified Organisms (GMO) as Investigational Medicinal Products (IMP) for contained use (CU) within the United Kingdom (UK). These submissions are unique to GMOs, in addition to Clinical Trial Authorisation (CTA) and Ethics
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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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pdf
27/02/2023

Manchester CRF (Christie site) Research Application Form

A proforma for submission to the Manchester Clinical Research Facility (Christie site), which outlines NHS Trust clinical and resource requirements, prior to study set up.
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pdf
07/05/2021

Research and Innovation Board Terms of Reference – The Christie

Terms of Refence for the Research and Innovation ATIMP Board (a sub-committee of the ATMP board) at The Christie Hospital Manchester. Included are aspects such as the boards powers and membership.
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pdf
27/02/2023

Research and Innovation Trial Feasibility proforma (IEC trial protocol review)

A proforma outlining considerations for an NHS Trust prior to commencing a cell therapy / immune effector cell trial.
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docx
22/01/2020

Risk assessment form – genetically modified organisms (GMOs) – contained use activities involving micro-organisms and cells

An example risk assessment form to be completed prior to the use of genetically modified organisms (GMO's) within a hospital
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Explore all clinical trials sub-sections

  • 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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